Trial Outcomes & Findings for Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds. (NCT NCT06600152)
NCT ID: NCT06600152
Last Updated: 2026-06-03
Results Overview
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
COMPLETED
NA
40 participants
Week 0 (treatment) up to Week 24 (End of Study)
2026-06-03
Participant Flow
Participants were recruited at three U.S. dermatologic surgery centers. Eligible subjects were identified from patients scheduled to undergo Mohs micrographic surgery for non-melanoma skin cancer. Screening, informed consent, eligibility confirmation, and enrollment were conducted on the same day as surgery. Subjects were enrolled consecutively based on protocol-defined criteria. A total of 40 subjects were enrolled, within the planned enrollment range.
All enrolled participants (N=40) were randomized and received the assigned intervention on the same day as enrollment. There were no exclusions between enrollment and assignment and no pre-assignment procedures (e.g., washout or run-in). No significant events occurred prior to assignment.
Participant milestones
| Measure |
Microporous Annealed Particle (MAP) Wound Matrix
The Microporous Annealed Particle (MAP) Wound Matrix device was topically applied to the wound immediately following Mohs micrographic surgery (MMS).
|
Hydrocolloid Dressing (DuoDerm)
A hydrocolloid (DuoDerm) was topically applied to the wound immediately following Mohs micrographic surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
14
|
|
Overall Study
COMPLETED
|
26
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
Baseline characteristics by cohort
| Measure |
Microporous Annealed Particle (MAP) Wound Matrix
n=26 Participants
The Microporous Annealed Particle (MAP) Wound Matrix device was topically applied to the wound immediately following Mohs micrographic surgery (MMS).
|
Hydrocolloid Dressing (DuoDerm)
n=14 Participants
A hydrocolloid (DuoDerm) was topically applied to the wound immediately following Mohs micrographic surgery.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 10 • n=20 Participants
|
80 years
STANDARD_DEVIATION 6 • n=20 Participants
|
78 years
STANDARD_DEVIATION 9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Week 0 (treatment) up to Week 24 (End of Study)Population: All randomized participants were included in the analysis population. The number of participants analyzed is identical to the number assigned to each arm (MAP Wound Matrix: 26; Control: 14). No participants were excluded from the analysis.
Incidence of serious adverse device effects (SADE) (including delays in wound healing and surgical site infections) in subjects treated with MAP Wound Matrix, compared to the control group.
Outcome measures
| Measure |
Microporous Annealed Particle (MAP) Wound Matrix
n=26 Participants
The Microporous Annealed Particle (MAP) Wound Matrix device was topically applied to the wound immediately following Mohs micrographic surgery (MMS).
|
Hydrocolloid Dressing (DuoDerm)
n=14 Participants
A hydrocolloid (DuoDerm) was topically applied to the wound immediately following Mohs micrographic surgery.
|
|---|---|---|
|
Incidence of Serious Adverse Device Effects in the Treatment Group Compared to the Control Group.
|
0 Participants
|
0 Participants
|
Adverse Events
Microporous Annealed Particle (MAP) Wound Matrix
Hydrocolloid Dressing (DuoDerm)
Serious adverse events
| Measure |
Microporous Annealed Particle (MAP) Wound Matrix
n=26 participants at risk
The Microporous Annealed Particle (MAP) Wound Matrix device was topically applied to the wound immediately following Mohs micrographic surgery (MMS).
|
Hydrocolloid Dressing (DuoDerm)
n=14 participants at risk
A hydrocolloid (DuoDerm) was topically applied to the wound immediately following Mohs micrographic surgery.
|
|---|---|---|
|
Infections and infestations
Pneumonia (aspiration)
|
0.00%
0/26 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
7.1%
1/14 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/26 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
7.1%
1/14 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
|
Cardiac disorders
Cardiac flutter with atrial fibrillation
|
0.00%
0/26 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
7.1%
1/14 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
Adverse events and serious adverse events were defined and collected in accordance with ICH E6(R2) and FDA regulations. The safety population included all participants who received study treatment (N=40), which is identical to the number assigned to each arm. No differences in definitions or analysis populations were applied.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place