N/A
N=46
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Hernia, Ventral · Intestinal Fistula · Fibromatosis, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT02228889 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Rate of Surgical Site Occurrences (SSOs) at 6 Week — 1; 11 event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abdominal wall reconstruction with Strattice (Procedure); Assess pain intensity at last office visit preoperatively (Other); Assess pain interference at last office visit preoperatively (Other); Assess physical functioning at last office visit preoperatively (Other); Assess patient quality of life at last office visit preoperatively (Other); Assess patient pain intensity postoperatively (Other); Assess pain interference postoperatively (Other); Assess physical functioning postoperatively (Other); Assess quality of life postoperatively (Other); Assess hernia recurrence at 30 days postoperatively (Other); Assess bulge at 30 days postoperatively (Other); Assess Surgical Site Occurrences at 30 days postoperatively (Other); Assess hernia recurrence at 1 year postoperatively (Other); Assess bulge at 1 year postoperatively (Other); Assess Surgical Site Occurrences at 1 year postoperatively (Other); Assess overall complications at 30 days postoperatively (Other); Assess overall complications at 1 year postoperatively (Other); Abdominal wall reconstruction with XenMatrix (Procedure); Strattice (Device); XenMatrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jeffrey Janis
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Surgical Site Occurrences (SSOs) at 6 Week |
1; 11 | — |
Summary
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Eligibility Criteria
Inclusion Criteria
- Age > 18
- Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
- Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Exclusion Criteria
- Known allergy to porcine products
- Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
- Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
- Patients with frank purulence in the wound
Data sourced from ClinicalTrials.gov (NCT02228889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.