A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

LifeCell23 sites in 1 country120 target enrollmentDecember 2008

ConditionsParastomal Hernia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Parastomal Hernia
Sponsor: LifeCell
Enrollment: 120
Locations: 23
Primary Endpoint: Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

July 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LifeCell

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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