Trial Outcomes & Findings for StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (NCT NCT04765202)
NCT ID: NCT04765202
Last Updated: 2025-05-16
Results Overview
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
At Month 2
Results posted on
2025-05-16
Participant Flow
Participants took part in the study at 5 investigative sites in the United States from 10 October 2021 to 07 June 2024.
The study was planned to be conducted in 2 cohorts. Only Cohort 1 data is reported, as the study was terminated before any participant was enrolled in Cohort 2. Total 13 participants were randomized in Cohort 1, each participant served as their own control. All participants had 2 treatment sites that were randomized to receive autograft treatment (AG Tx) at 1 treatment site, and StrataGraft overlay of meshed autograft (SOMA Tx) on the 2nd treatment site.
Unit of analysis: treatment sites
Participant milestones
| Measure |
Cohort1 Group1: AG Tx
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group1: SOMA Tx
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm\^2) in area on Day 1.
|
Cohort1 Group2: AG Tx
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group2: SOMA Tx
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7 7
|
7 7
|
6 6
|
6 6
|
|
Overall Study
COMPLETED
|
6 6
|
6 6
|
3 3
|
3 3
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
3 3
|
3 3
|
Reasons for withdrawal
| Measure |
Cohort1 Group1: AG Tx
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group1: SOMA Tx
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm\^2) in area on Day 1.
|
Cohort1 Group2: AG Tx
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group2: SOMA Tx
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Baseline characteristics by cohort
| Measure |
Cohort 1 Group 1
n=7 Participants
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 2
n=6 Participants
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 12.20 • n=99 Participants
|
47.2 years
STANDARD_DEVIATION 12.54 • n=107 Participants
|
47.3 years
STANDARD_DEVIATION 11.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Month 2Population: FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx.
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Outcome measures
| Measure |
Cohort1 Group1: AG Tx
n=7 sites
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group1: SOMA Tx
n=7 sites
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort1 Group2: AG Tx
n=6 sites
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group2: SOMA Tx
n=6 sites
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|
|
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
|
6 treatment sites
|
7 treatment sites
|
6 treatment sites
|
6 treatment sites
|
PRIMARY outcome
Timeframe: At Month 12Population: FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx. Here, the overall number analyzed of participants are the number of participants with data available for analysis.
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
Outcome measures
| Measure |
Cohort1 Group1: AG Tx
n=6 Participants
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group1: SOMA Tx
n=3 Participants
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort1 Group2: AG Tx
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort1 Group2: SOMA Tx
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
AG Tx Site
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
SOMA Tx Site
|
6 Participants
|
3 Participants
|
—
|
—
|
Adverse Events
Cohort 1 Group 1: All Participants
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1 Group 1: AG Tx Sites
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 Group 1: SOMA Tx Sites
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1 Group 2: All Participants
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1 Group 2: AG Tx Sites
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 Group 2: SOMA Tx Sites
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Group 1: All Participants
n=7 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 1: AG Tx Sites
n=7 participants at risk
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort 1 Group 1: SOMA Tx Sites
n=7 participants at risk
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 2: All Participants
n=6 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 2: AG Tx Sites
n=6 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort 1 Group 2: SOMA Tx Sites
n=6 participants at risk
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Homicidal ideation
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
Other adverse events
| Measure |
Cohort 1 Group 1: All Participants
n=7 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 1: AG Tx Sites
n=7 participants at risk
Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort 1 Group 1: SOMA Tx Sites
n=7 participants at risk
Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 2: All Participants
n=6 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
Cohort 1 Group 2: AG Tx Sites
n=6 participants at risk
Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
|
Cohort 1 Group 2: SOMA Tx Sites
n=6 participants at risk
Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
General disorders
Pain
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Pilonidal cyst
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Vascular device infection
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Injury, poisoning and procedural complications
Skin graft failure
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
33.3%
2/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
33.3%
2/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
33.3%
2/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
28.6%
2/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
14.3%
1/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Investigations
Blood pressure diastolic abnormal
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
0.00%
0/7 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
16.7%
1/6 • Up to 13 months
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place