Phase 4
N=120
Parastomal Reinforcement With Strattice
Parastomal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT00771407 ↗Enrolled (actual)
120
Serious AEs
65.5%
Results posted
Sep 2015
Primary outcome: Primary: Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. — 6; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Strattice Reconstructive Matrix (Device); Standard ostomy creation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LifeCell
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. |
6; 7 | — |
| SECONDARY Stoma Complications |
— | — |
| SECONDARY Stoma Complications |
— | — |
| SECONDARY Stoma Quality of Life |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00771407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.