Parastomal Reinforcement With Strattice

Phase 4

Completed

• Conditions: Parastomal Hernia
• Interventions: Other: Standard ostomy creation; Device: Strattice Reconstructive Matrix

• Registration Number: NCT00771407
• Lead Sponsor: LifeCell

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2008-12
• Primary Completion: 2012-02
• Study Completion: 2012-07
• Results First Submitted: 2013-08-20
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-25
• Last Update Submitted: 2015-08-25
• Results First Posted: 2015-09-28
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• adults
• need for permanent ileostomy or colostomy

Exclusion Criteria

• history of hernia at new ostomy site
• has previously implanted surgical mesh at site of planned ostomy
• requires a temporary ostomy
• has need for multiple ostomies
• is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
• is bedridden or otherwise non-ambulatory

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ostomy construction	Standard ostomy creation	Ostomy will be created in the standard fashion
Strattice fascial inlay	Strattice Reconstructive Matrix	Strattice will be placed as a fascial inlay to support the ostomy site

Primary Outcome Measures

Name	Time	Method
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.	24 months

Secondary Outcome Measures

Name	Time	Method
Stoma Complications	more than 1 month postoperatively
Stoma Quality of Life	Serially over 24 months

Trial Locations

Locations (23)

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Christ Hospital Research; 🇺🇸 Cincinnati, Ohio, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Washington University School of Medicine - Barnes Jewish West; 🇺🇸 St Louis, Missouri, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

Office of Dr Phillip Fleshner; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

University of California at Irvine; 🇺🇸 Orange, California, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States

University of Maryland/Baltimore VA; 🇺🇸 Baltimore, Maryland, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Ochsner Clinic; 🇺🇸 New Orleans, Louisiana, United States

Spectrum Health - Butterworth Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Colon & Rectal Surgery Inc; 🇺🇸 Omaha, Nebraska, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Mt Sinai Medical Center; 🇺🇸 New York City, New York, United States

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Colon and Rectal Surgery Associates Ltd; 🇺🇸 St Paul, Minnesota, United States