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

Not Applicable

• Conditions: Surgical Site Infection; Wound Heal
• Interventions: Procedure: Linear skin closure with wound drain; Procedure: Purse-string skin closure with negative pressure wound therapy

• Registration Number: NCT04986111
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-25
• Status Verified: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-22
• Last Update Submitted: 2021-07-22
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linear skin closure with wound drain	Linear skin closure with wound drain	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.
Purse-string skin closure with negative pressure wound therapy	Purse-string skin closure with negative pressure wound therapy	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.

Primary Outcome Measures

Name	Time	Method
Unsuccessful wound recovery rate	Check at postoperative 30th day and report through study completion, an average of 1 year	(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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of