A Randomized Trial of Ostomy Closure Techniques
Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure|
- surgical site infection [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]
- delayed wound healing [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]Evidence of delayed wound-healing at stoma takedown site
- patient satisfaction [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]We are measuring subject satisfaction with wound healing and cosmetic outcome
|Study Start Date:||December 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Purse string closure
Patients undergo a purse string closure of their old stoma site.
Procedure: Purse string closure
Active Comparator: Primary closure
Patients have their stoma sites close primarily with staples.
Procedure: Primary closure
The investigators will randomize ileostomy takedown patients to either a primary closure or purse string closure technique intraoperatively. Surgeons at both the University of Minnesota and the CHUV hospital in Switzerland will participate in the this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713452
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|