Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns (NCT NCT02148705)

Last Updated: 2024-07-10

Results Overview

Comparison of NexoBrid over Gel Vehicle for eschar removal as measured by Number of Participants with complete eschar removal at the end of the topical agent soaking period by a blinded assessor.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

post application (post 2 h soaking)

Results posted on

2024-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	NexoBrid Gel NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle	Standard of Care (SOC) Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC)
Overall Study STARTED	75	25	75
Overall Study Treated	77	24	68
Overall Study Completed Acute Phase	67	23	63
Overall Study Completed 12M FU Period	57	20	58
Overall Study COMPLETED	57	20	58
Overall Study NOT COMPLETED	18	5	17

Reasons for withdrawal

Reasons for withdrawal
Measure	NexoBrid Gel NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle	Standard of Care (SOC) Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC)
Overall Study Death	2	0	0
Overall Study Lost to Follow-up	13	4	10
Overall Study Withdrawal by Subject	3	0	2
Overall Study Not Treated	0	1	5

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NexoBrid Gel n=75 Participants NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=25 Participants Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle	Standard of Care (SOC) n=75 Participants Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC)	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=99 Participants	21 Participants n=107 Participants	70 Participants n=206 Participants	159 Participants n=7 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants	16 Participants n=7 Participants
Age, Continuous	41.28 years STANDARD_DEVIATION 15.03 • n=99 Participants	40.68 years STANDARD_DEVIATION 17.30 • n=107 Participants	40.91 years STANDARD_DEVIATION 15.16 • n=206 Participants	40.95 years STANDARD_DEVIATION 15.03 • n=7 Participants
Sex: Female, Male Female	26 Participants n=99 Participants	10 Participants n=107 Participants	16 Participants n=206 Participants	52 Participants n=7 Participants
Sex: Female, Male Male	49 Participants n=99 Participants	15 Participants n=107 Participants	59 Participants n=206 Participants	123 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=99 Participants	8 Participants n=107 Participants	8 Participants n=206 Participants	30 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=99 Participants	17 Participants n=107 Participants	67 Participants n=206 Participants	145 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants	3 Participants n=107 Participants	13 Participants n=206 Participants	24 Participants n=7 Participants
Race (NIH/OMB) White	61 Participants n=99 Participants	21 Participants n=107 Participants	59 Participants n=206 Participants	141 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants

PRIMARY outcome

Timeframe: post application (post 2 h soaking)

Population: Standard of Care (SOC) is not included as it was pre-specified in the statistical analysis plan that for the primary endpoint, NexoBrid Gel will be compared only to the Gel Vehicle

Comparison of NexoBrid over Gel Vehicle for eschar removal as measured by Number of Participants with complete eschar removal at the end of the topical agent soaking period by a blinded assessor.

Outcome measures

Outcome measures
Measure	NexoBrid Gel n=75 Participants NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=25 Participants Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle
Primary Endpoint: Number of Participants With Complete Eschar Removal.	70 Participants	1 Participants

SECONDARY outcome

Timeframe: Post application (post 2 h soaking) for NexoBrid arm and immediately post surgical excision for SOC arm.

Population: Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC

Comparison of NexoBrid over SOC in number of Participants with surgical need for excisional eschar removal as measured by an analysis of incidence of surgical eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).

Outcome measures

Outcome measures
Measure	NexoBrid Gel n=75 Participants NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=75 Participants Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle
Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)	3 Participants	54 Participants

SECONDARY outcome

Timeframe: From randomization until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.

Population: Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC

Comparison of NexoBrid over SOC with regard to the time (in days) when complete eschar removal has been achieved. Results of the Generalized Wilcoxon-Gehan Test Adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs (FAS)

Outcome measures

Outcome measures
Measure	NexoBrid Gel n=75 Participants NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=75 Participants Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle
Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal	1.02 Days Interval 0.98 to 1.07	3.87 Days Interval 1.98 to 5.98

SECONDARY outcome

Timeframe: For NexoBrid arm, blood loss during NexoBrid application until post soaking. For SOC arm, blood loss during SOC procedures, through last dressing change for non-surgical SOC arm and through excision surgery for surgical SOC arm.

Population: Gel arm is not involved in comparison as defined in the statistical analysis plan. Only NexoBrid and SOC were compared

Comparison of NexoBrid over SOC with regard to the blood loss (volume in mL) occurred during the eschar removal procedures.

Outcome measures

Outcome measures
Measure	NexoBrid Gel n=75 Participants NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=75 Participants Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle
Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)	14.17 mL Standard Deviation 512.40	814.51 mL Standard Deviation 1020.32

Adverse Events

NexoBrid Gel

Serious events: 9 serious events

Other events: 49 other events

Deaths: 2 deaths

Gel Vehicle

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Standard of Care (SOC)

Serious events: 9 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Keren David Zarbiv

MediWound

Phone: 972-77-9714103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	NexoBrid Gel n=77 participants at risk NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=24 participants at risk Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle	Standard of Care (SOC) n=68 participants at risk Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC)
Congenital, familial and genetic disorders Atrial Septal Defect	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Congenital Tricuspid Valve Incompetence	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Laryngomalacia	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Patent Ductus Arteriosus	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Persistent Fetal Circulation	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Trisomy 21	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Congenital, familial and genetic disorders Ventricular Septal Defect	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Cellulitis	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Sepsis	2.6% 2/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Injury, poisoning and procedural complications Intentional Overdose	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of the Oral Cavity	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Nervous system disorders Cerebral Ventricle Dilatation	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Pregnancy, puerperium and perinatal conditions Failure to Thrive	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Psychiatric disorders Suicide Attempt	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Psychiatric disorders Anxiety	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Renal and urinary disorders Acute Kidney Injury	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Respiratory, thoracic and mediastinal disorders Neonatal Respiratory Failure	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Respiratory, thoracic and mediastinal disorders Transient Tachypnoea of the Newborn	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Surgical and medical procedures Eventration Repair	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Vascular disorders Deep Vein Thrombosis	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Cardiac disorders Acute Coronary syndrome	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Cardiac disorders Bifascicular Block	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Gastrointestinal disorders Appendicitis Noninfective	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Gastrointestinal disorders Subileus	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
General disorders Death	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
General disorders Chest Pain	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
General disorders Infusion Site Thrombosis	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Wound Infection Bacterial	2.6% 2/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Diverticulitis	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Osteomyelitis	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Urosepsis	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Clostridium Difficile Infection	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Septic Shock	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Injury, poisoning and procedural complications Thermal Burn	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Injury, poisoning and procedural complications Graft Loss	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Nervous system disorders Seizure	0.00% 0/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.

Other adverse events
Measure	NexoBrid Gel n=77 participants at risk NexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours. NexoBrid	Gel Vehicle n=24 participants at risk Gel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours. Gel Vehicle	Standard of Care (SOC) n=68 participants at risk Subjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment. Standard of Care (SOC)
Blood and lymphatic system disorders Leukocytosis	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Cardiac disorders Tachycardia	6.5% 5/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Gastrointestinal disorders Nausea	6.5% 5/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	12.5% 3/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	2.9% 2/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Gastrointestinal disorders Vomiting	6.5% 5/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	1.5% 1/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Gastrointestinal disorders Constipation	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	8.3% 2/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	8.8% 6/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
General disorders Pyrexia	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	8.3% 2/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	7.4% 5/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
General disorders Pain	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	2.9% 2/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Urinary Tract Infection	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Wound Infection Bacterial	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	5.9% 4/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Sepsis	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Infections and infestations Sinusitus	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.4% 3/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Injury, poisoning and procedural complications Graft Loss	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.4% 3/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Injury, poisoning and procedural complications Wound Complications	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	2.9% 2/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Musculoskeletal and connective tissue disorders Joint Range of Motion Decreased	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	16.7% 4/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	7.4% 5/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Musculoskeletal and connective tissue disorders Pain in Extremity	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Nervous system disorders Headache	3.9% 3/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	12.5% 3/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Psychiatric disorders Insomnia	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.2% 1/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	4.4% 3/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Skin and subcutaneous tissue disorders Pruritis	7.8% 6/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	12.5% 3/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	7.4% 5/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Skin and subcutaneous tissue disorders Rash	5.2% 4/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.
Investigations Lymphocyte Count Decreased	1.3% 1/77 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	8.3% 2/24 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.	0.00% 0/68 • Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study. An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.