A Randomized Trial of Ostomy Closure Techniques

NCT01713452 | Completed

• 1 other identifier: 0806M37362
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Infection

Keywords

Surgical Stomas; ileostomy; surgical site infection

Outcome Measures

Primary Outcomes (1)

• surgical site infection

  30 days postoperatively

Secondary Outcomes (2)

• delayed wound healing

  30 days postoperatively

• patient satisfaction

  30 days postoperatively

Study Arms (2)

Purse string closure

ACTIVE COMPARATOR

Patients undergo a purse string closure of their old stoma site.

Procedure: Purse string closure

Primary closure

ACTIVE COMPARATOR

Patients have their stoma sites close primarily with staples.

Procedure: Primary closure

Interventions

Purse string closure PROCEDURE

1. 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. 2. 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. 3. Diameter of the skin defect should then be measured. 4. A postoperative photo will then be taken.

Purse string closure

Primary closure PROCEDURE

1. 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. 2. 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. 3. Length of the incision should be measured in centimeters. 4. A postoperative photo will then be taken.

Primary closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Subjects will be excluded from the study if:
• The stoma site is left open to heal by secondary intention due to gross contamination (surgeon discretion)
• The stoma site is re-used (i.e. the same stoma site used for the formation of a new ostomy)
• A new stoma is created at a different site.

Sponsors & Collaborators

• University of Minnesota: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209.

  PMID: 25285695 DERIVED

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: December 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)