A Randomized Trial of Ostomy Closure Techniques

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Centre hospitalier universitaire vaudois, Lausanne, Switzerland

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01713452

First received: October 22, 2012

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention
Wound Infection	Procedure: Purse string closure Procedure: Primary closure

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Ostomy

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

surgical site infection [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	125
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Purse string closure Patients undergo a purse string closure of their old stoma site.	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.
Active Comparator: Primary closure Patients have their stoma sites close primarily with staples.	Procedure: 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.

Arms

Assigned Interventions

Active Comparator: Purse string closure

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

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.

Active Comparator: Primary closure

Patients have their stoma sites close primarily with staples.

Procedure: 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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713452

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Centre hospitalier universitaire vaudois, Lausanne, Switzerland

More Information

No publications provided

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01713452 History of Changes
Other Study ID Numbers:	IRB#0806M37362
Study First Received:	October 22, 2012
Last Updated:	October 23, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Surgical Stomas
ileostomy
surgical site infection

Additional relevant MeSH terms:

Wound Infection
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013

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