NCT01295125

Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

Detailed description

This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue. The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects. This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	XenMATRIX mesh	Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
PROCEDURE	Open abdominal ventral hernia repair	Abdominal ventral hernia repair with native tissue

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-02-14
• Last updated: 2023-01-25
• Results posted: 2023-01-25

Locations

1 site across 1 country: United States