Trial Outcomes & Findings for RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction (NCT NCT02228889)
NCT ID: NCT02228889
Last Updated: 2025-06-06
Results Overview
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
6 week postoperatively
Results posted on
2025-06-06
Participant Flow
There were no significant events in the study. Enrollment was stopped prior to the pre-determined 70 total participants, as a shift in practice and national trend toward the use of synthetic mesh over biologic mesh hindered participant recruitment.
Participant milestones
| Measure |
Strattice
Abdominal wall reconstruction with Strattice Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
|
XenMatrix
Abdominal wall reconstruction with XenMatrix Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
30
|
|
Overall Study
COMPLETED
|
16
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Strattice
n=16 Participants
Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis
|
XenMatrix
n=30 Participants
Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=16 Participants
|
57 years
n=30 Participants
|
60 years
n=46 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=16 Participants
|
14 Participants
n=30 Participants
|
24 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=16 Participants
|
16 Participants
n=30 Participants
|
22 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
29.6 kg/m^2
n=16 Participants
|
33.1 kg/m^2
n=30 Participants
|
33.1 kg/m^2
n=46 Participants
|
|
Number of prior Hernia Repairs
|
2.5 prior repairs
n=16 Participants
|
1 prior repairs
n=30 Participants
|
1 prior repairs
n=46 Participants
|
|
Hernia Width
|
15.8 cm
n=16 Participants
|
12.9 cm
n=30 Participants
|
12.9 cm
n=46 Participants
|
|
Diabetes
|
7 Participants
n=16 Participants
|
7 Participants
n=30 Participants
|
14 Participants
n=46 Participants
|
|
Hypertension
|
7 Participants
n=16 Participants
|
14 Participants
n=30 Participants
|
21 Participants
n=46 Participants
|
|
COPD
|
5 Participants
n=16 Participants
|
5 Participants
n=30 Participants
|
10 Participants
n=46 Participants
|
|
Immunosuppression
|
2 Participants
n=16 Participants
|
10 Participants
n=30 Participants
|
12 Participants
n=46 Participants
|
|
Previous Hernia Repair
|
11 Participants
n=16 Participants
|
20 Participants
n=30 Participants
|
31 Participants
n=46 Participants
|
|
ASA Class
Stage I
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=46 Participants
|
|
ASA Class
Stage II
|
3 Participants
n=16 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=46 Participants
|
|
ASA Class
Stage IIII
|
13 Participants
n=16 Participants
|
24 Participants
n=30 Participants
|
37 Participants
n=46 Participants
|
|
ASA Class
Stage IV
|
0 Participants
n=16 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=46 Participants
|
|
ASA Class
Stage V
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=46 Participants
|
|
Ventral Hernia Working Group
1
|
1 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=46 Participants
|
|
Ventral Hernia Working Group
2
|
2 Participants
n=16 Participants
|
9 Participants
n=30 Participants
|
11 Participants
n=46 Participants
|
|
Ventral Hernia Working Group
3
|
11 Participants
n=16 Participants
|
13 Participants
n=30 Participants
|
24 Participants
n=46 Participants
|
|
Ventral Hernia Working Group
4
|
2 Participants
n=16 Participants
|
7 Participants
n=30 Participants
|
9 Participants
n=46 Participants
|
|
Kanters Grade
1
|
1 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=46 Participants
|
|
Kanters Grade
2
|
6 Participants
n=16 Participants
|
16 Participants
n=30 Participants
|
22 Participants
n=46 Participants
|
|
Kanters Grade
3
|
9 Participants
n=16 Participants
|
13 Participants
n=30 Participants
|
22 Participants
n=46 Participants
|
|
Primary Fascial Repair
|
14 Participants
n=16 Participants
|
22 Participants
n=30 Participants
|
36 Participants
n=46 Participants
|
|
Unilateral Component Separation
|
2 Participants
n=16 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=46 Participants
|
|
Bridged Repair
|
2 Participants
n=16 Participants
|
6 Participants
n=30 Participants
|
8 Participants
n=46 Participants
|
|
Total OR Time
|
471 minutes
n=16 Participants
|
417 minutes
n=30 Participants
|
417 minutes
n=46 Participants
|
PRIMARY outcome
Timeframe: 6 week postoperativelyPopulation: participants who got to 6 weeks
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Outcome measures
| Measure |
Strattice
n=16 Participants
Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis
|
XenMatrix
n=30 Participants
Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis
|
|---|---|---|
|
Rate of Surgical Site Occurrences (SSOs) at 6 Week
|
1 event
Standard Error 6.25
|
11 event
Standard Error 36.67
|
Adverse Events
Strattice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
XenMatrix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeffrey Janis
The Ohio State University Wexner Medical Center
Phone: (614) 297-2913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place