A Randomized Trial of Ostomy Closure Techniques

Wound Infection Clinical Trial

Official title:

A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713452
• Other study ID #: 0806M37362
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer)

Exclusion Criteria:

Subjects will be excluded from the study if:

1. The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion)

2. The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy)

3. A new stoma is created at a different site.

Related Conditions & MeSH terms

• Wound Infection

Intervention

Procedure:
• Purse string closure
An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group. Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing. Diameter of the skin defect should then be measured. A postoperative photo will then be taken.
• Primary closure
An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed. Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (<1.5cm). No subcutaneous drains will be placed. Length of the incision should be measured in centimeters. A postoperative photo will then be taken.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical site infection		30 days postoperatively
Secondary	delayed wound healing	Evidence of delayed wound-healing at stoma takedown site	30 days postoperatively
Secondary	patient satisfaction	We are measuring subject satisfaction with wound healing and cosmetic outcome	30 days postoperatively