Clinical trial · Interventional
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
NCT02228889CI-TRIAL-00090686completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibromatosis, Abdominal | Abdominal (Mesenteric) Fibromatosis | ALIAS | 0.90 |
| Hernia, Ventral | — | UNRESOLVED | — |
| Intestinal Fistula | — | UNRESOLVED | — |
Interventions
Interventions (20)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal wall reconstruction with Strattice | Procedure | — | UNRESOLVED |
| Abdominal wall reconstruction with XenMatrix | Procedure | — | UNRESOLVED |
| Assess bulge at 1 year postoperatively | Other | — | UNRESOLVED |
| Assess bulge at 30 days postoperatively | Other | — | UNRESOLVED |
| Assess hernia recurrence at 1 year postoperatively | Other | — | UNRESOLVED |
| Assess hernia recurrence at 30 days postoperatively | Other | — | UNRESOLVED |
| Assess overall complications at 1 year postoperatively | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Strattice
- description
- Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively 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
- interventionNames
- Procedure: Abdominal wall reconstruction with Strattice
- Other: 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDElemosho A, Sarac BA, Olson MA, Khansa I, Hackenberger PN, Narula V, Eiferman DS, Janis JE. Comparative Outcomes of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Complex Abdominal Wall Reconstruction: A Randomized Controlled Trial and an Observational Cohort Study. World J Surg. 2026 Apr;50(4):848-859. doi: 10.1002/wjs.70271. Epub 2026 Feb 20. PMID 41720620