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Parastomal Reinforcement With Strattice

NCT00771407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-09-28

Study results available
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Summary

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Conditions

  • Parastomal Hernia

Interventions

DEVICE

Strattice Reconstructive Matrix

Strattice will be placed as a fascial inlay to support stoma sites

OTHER

Standard ostomy creation

Ostomy will be created as routinely performed

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • James Fleshman, MD · Washington University, St Louis MO

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-02-29
Completion
2012-07-31

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 NCT00771407 on ClinicalTrials.gov