The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) After Ileostomy Reversal

Study Overview
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Brief Summary
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Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study

Official Title
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The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) on Wound Recovery After Ileostomy Reversal: A Prospective Randomized Clinical Trial

Conditions
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Surgical Site Infection, Wound Heal

Intervention / Treatment
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* Procedure: Linear skin closure with wound drain
* Procedure: Purse-string skin closure with negative pressure wound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients experiencing ileostomy repair at multicenter Exclusion Criteria: Active bacterial infection needing antibiotics before surgery parastomal infection before surgery uncontrolled diabetes mellitus Emergency repair of stoma (ex. stoma prolapse, high output stoma etc...) Inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linear skin closure with wound drain<br>Reduce fluid collection and dead space by inserting drain into the subcutaneous layer using the wound closure method previously used in the experimental center. The linear suture has a relatively quick time to stitch out. | Procedure: Linear skin closure with wound drain<br>* An oval incision is made around the ileostomy and the continuity of the intestinal tract is restored after adhesion division. Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling. Linear suture of the rectus abdominis fascia layer by layer. A Jackson-Pratt drainage tube is placed in the subcutaneous tissue and vertical mattress suture is performed with a non-absorbable thread.<br>|
| Active Comparator: Purse-string skin closure with negative pressure wound therapy<br>Close the wound with a purse-string suture which is better in terms of surgical site infection but known to take a long time for wound healing, and use negative pressure wound therapy to help granulation of tissues and help healing. | Procedure: Purse-string skin closure with negative pressure wound therapy<br>* Recover the intestinal continuity after adhesion division by making a circular incision along the ileostomy Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling. Linear suture of the rectus abdominis fascia layer by layer. Negative pressure wound therapy is performed after suturing the subcutaneous tissue using absorbable thread.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsuccessful wound recovery rate | (patients with unsuccessful wound recovery / all enrolled patients) x 100 **Unsuccessful wound recovery definition: 1) Occurrence of Surgical Site Infection (SSI) or 2) reoperation due to wound complication or 3) delayed healing over 30 days or 4) Out patient department follow up more than 5 times | Check at postoperative 30th day and report through study completion, an average of 1 year |