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Completed

NCT Number: NCT01713452

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.

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Key information

Conditions

Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Treatment and study plan

Purse string closure

Procedure
  • 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

Procedure
  • 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.

Primary outcomes

  1. surgical site infection

    Time frame: 30 days postoperatively

Secondary outcomes

  1. delayed wound healing

    Time frame: 30 days postoperatively

    Evidence of delayed wound-healing at stoma takedown site

  2. patient satisfaction

    Time frame: 30 days postoperatively

    We are measuring subject satisfaction with wound healing and cosmetic outcome

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2012
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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