Back to resultsA Randomized Trial of Ostomy Closure Techniques
Primary Purpose
Wound Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Purse string closure
Primary closure
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection focused on measuring Surgical Stomas, ileostomy, surgical site infection
Eligibility 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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Purse string closure
Primary closure
Arm Description
Patients undergo a purse string closure of their old stoma site.
Patients have their stoma sites close primarily with staples.
Outcomes
Primary Outcome Measures
surgical site infection
Secondary Outcome Measures
delayed wound healing
Evidence of delayed wound-healing at stoma takedown site
patient satisfaction
We are measuring subject satisfaction with wound healing and cosmetic outcome
Full Information
NCT ID
NCT01713452
First Posted
October 22, 2012
Last Updated
October 30, 2019
Sponsor
University of Minnesota
Collaborators
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT01713452
Brief Title
A Randomized Trial of Ostomy Closure Techniques
Official Title
A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Surgical Stomas, ileostomy, surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Purse string closure
Arm Type
Active Comparator
Arm Description
Patients undergo a purse string closure of their old stoma site.
Arm Title
Primary closure
Arm Type
Active Comparator
Arm Description
Patients have their stoma sites close primarily with staples.
Intervention Type
Procedure
Intervention Name(s)
Purse string closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Primary closure
Intervention Description
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 Outcome Measure Information:
Title
surgical site infection
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
delayed wound healing
Description
Evidence of delayed wound-healing at stoma takedown site
Time Frame
30 days postoperatively
Title
patient satisfaction
Description
We are measuring subject satisfaction with wound healing and cosmetic outcome
Time Frame
30 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25285695
Citation
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.
Results Reference
derived
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A Randomized Trial of Ostomy Closure Techniques
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