RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

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.

Conditions

• Hernia, Ventral
• Intestinal Fistula
• Fibromatosis, Abdominal

Interventions

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

Sponsors & Collaborators

• Jeffrey Janis

  lead OTHER

Principal Investigators

• Jeffrey E Janis, MD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2025-03-27

Completion

2025-03-27

Countries

• United States

Study Locations