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Comparative Study of Biologic Mesh Versus Repair With Component Separation.

NCT01295125 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-01-25

Study results available
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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.

Conditions

  • Ventral Hernia

Interventions

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

Sponsors & Collaborators

  • Bard Ltd

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Michael J. Rosen, MD. · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295125 on ClinicalTrials.gov