NCT02228889

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Jeffrey Janis · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not). Our goals in this study are: 1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively 2. SECONDARY OUTCOMES i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey

Conditions

• Hernia, Ventral
• Intestinal Fistula
• Fibromatosis, Abdominal

Interventions

Type	Name	Description
PROCEDURE	Abdominal wall reconstruction with Strattice	Abdominal wall reconstruction using Strattice
OTHER	Assess pain intensity at last office visit preoperatively	Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
OTHER	Assess pain interference at last office visit preoperatively	Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
OTHER	Assess physical functioning at last office visit preoperatively	Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
OTHER	Assess patient quality of life at last office visit preoperatively	Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
OTHER	Assess patient pain intensity postoperatively	Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
OTHER	Assess pain interference postoperatively	Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
OTHER	Assess physical functioning postoperatively	Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
OTHER	Assess quality of life postoperatively	Assess quality of life at 1 year postoperatively using the HerQLes survey
OTHER	Assess hernia recurrence at 30 days postoperatively	Assess hernia recurrence at 30 days
OTHER	Assess bulge at 30 days postoperatively	Assess bulge at 30 days
OTHER	Assess Surgical Site Occurrences at 30 days postoperatively	Assess Surgical Site Occurrences at 30 days
OTHER	Assess hernia recurrence at 1 year postoperatively	Assess hernia recurrence at 1 year postoperatively
OTHER	Assess bulge at 1 year postoperatively	Assess bulge at 1 year postoperatively
OTHER	Assess Surgical Site Occurrences at 1 year postoperatively	Assess Surgical Site Occurrences at 1 year postoperatively
OTHER	Assess overall complications at 30 days postoperatively
OTHER	Assess overall complications at 1 year postoperatively
PROCEDURE	Abdominal wall reconstruction with XenMatrix	Abdominal wall reconstruction with XenMatrix
DEVICE	Strattice	Strattice mesh
DEVICE	XenMatrix	Xenmatrix mesh

Timeline

• Start date: 2015-01-01
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2014-08-29
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

1 site across 1 country: United States