Parastomal Reinforcement With Strattice

Parastomal Hernia Clinical Trial

— PriSm  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771407
• Other study ID #: LFC2008.01.01
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2008
• Last updated: August 25, 2015
• Start date: December 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2015
• Source: LifeCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

• Parastomal Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Maryland/Baltimore VA	Baltimore	Maryland
United States	University of Vermont	Burlington	Vermont
United States	University of Illinois	Chicago	Illinois
United States	The Christ Hospital Research	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Spectrum Health - Butterworth Hospital	Grand Rapids	Michigan
United States	The Methodist Hospital	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Office of Dr Phillip Fleshner	Los Angeles	California
United States	University of South Alabama	Mobile	Alabama
United States	Louisiana State University	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Mt Sinai Medical Center	New York City	New York
United States	Colon & Rectal Surgery Inc	Omaha	Nebraska
United States	University of California at Irvine	Orange	California
United States	Washington University School of Medicine - Barnes Jewish West	St Louis	Missouri
United States	Colon and Rectal Surgery Associates Ltd	St Paul	Minnesota
United States	Stanford University Medical Center	Stanford	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.		24 months	No
Secondary	Stoma Complications		30 days	Yes
Secondary	Stoma Complications		more than 1 month postoperatively	Yes
Secondary	Stoma Quality of Life		Serially over 24 months	No