Trial Outcomes & Findings for Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions (NCT NCT02704104)

Last Updated: 2018-08-07

Results Overview

Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up. Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

30 Days Post Procedure

Results posted on

2018-08-07

Participant Flow

Patients were recruited who were to undergo excision of two skin lesions in the same sitting.

Participant milestones

Participant milestones
Measure	All Study Participants All study participants had two freshly excised lesions, each randomized to either application of a topical hemostatic device (AC5) or control (saline) treatment.
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=46 Participants Characteristics of the 46 patients enrolled in the study
Age, Continuous	57 years STANDARD_DEVIATION 15.5 • n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	45 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Ireland	46 participants n=99 Participants
Antiplatelet therapy	10 Participants n=99 Participants

PRIMARY outcome

Timeframe: 30 Days Post Procedure

Outcome measures

Outcome measures
Measure	AC5 Topical Hemostatic Device n=46 Participants The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions	Control n=46 Participants The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At time of application (Day 0)

Population: Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.

Measure of time from application of treatment or control to the wound, to bleeding cessation

Outcome measures

Outcome measures
Measure	AC5 Topical Hemostatic Device n=46 Participants The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions	Control n=46 Participants The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
Median Time to Hemostasis (Seconds)	24.5 seconds Interval 7.0 to 165.0	44 seconds Interval 10.0 to 387.0

SECONDARY outcome

Timeframe: At time of application (Day 0)

Population: Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.

Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area

Outcome measures

Outcome measures
Measure	AC5 Topical Hemostatic Device n=46 Participants The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions	Control n=46 Participants The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
Time to Hemostasis in Seconds Per Square Centimeter Wound Area	42 seconds/cm2 Interval 5.0 to 1100.0	104 seconds/cm2 Interval 6.0 to 797.0

SECONDARY outcome

Timeframe: 7 and 30 Days Post Procedure

Population: Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.

The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and \>40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.

Outcome measures

Outcome measures
Measure	AC5 Topical Hemostatic Device n=46 Participants The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions	Control n=46 Participants The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30 Day 7	40 wounds	40 wounds
Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30 Day 30	44 wounds	44 wounds

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: The overall number of patients is 46, 10 of whom were taking anti platelet therapy at the time of the procedure.

Outcome measures

Outcome measures
Measure	AC5 Topical Hemostatic Device n=46 Participants The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions	Control n=46 Participants The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions
Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication Taking antiplatelet therapy	24 seconds Interval 7.0 to 120.0	90 seconds Interval 23.0 to 387.0
Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication Not taking antiplatelet therapy	24 seconds Interval 8.0 to 165.0	40 seconds Interval 10.0 to 244.0

Adverse Events

AC5 Topical Hemostatic Device

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AC5 Topical Hemostatic Device n=46 participants at risk The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient	Control n=46 participants at risk The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient
Injury, poisoning and procedural complications Wound complication	8.7% 4/46 • Number of events 5 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.	8.7% 4/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.
General disorders Secretion discharge	6.5% 3/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.	6.5% 3/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.
Investigations Fibrin D dimer increased	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.
Injury, poisoning and procedural complications Wound hemorrhage	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.
Musculoskeletal and connective tissue disorders Back pain	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.	4.3% 2/46 • 30 days Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.

Additional Information

Medical/Scientific Affairs

Arch Therapeutics, Inc

Phone: 617 431-2313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place