Trials / Completed
CompletedNCT00771407
Parastomal Reinforcement With Strattice
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- LifeCell · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2012-02-01
- Completion
- 2012-07-01
- First posted
- 2008-10-13
- Last updated
- 2015-09-28
- Results posted
- 2015-09-28
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00771407. Inclusion in this directory is not an endorsement.