Parastomal Reinforcement With Strattice (PriSm)

LifeCell

Status and phase: Completed; Phase 4

Conditions: Parastomal Hernia

Treatments: Other: Standard ostomy creation; Device: Strattice Reconstructive Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00771407

LFC2008.01.01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Strattice fascial inlay

Active Comparator group

Description:

Strattice will be placed as a fascial inlay to support the ostomy site

Treatment:

Device: Strattice Reconstructive Matrix

Standard ostomy construction

Other group

Description:

Ostomy will be created in the standard fashion

Treatment:

Other: Standard ostomy creation