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

Not Applicable

• Conditions: Surgical Site Infection; Wound Heal

• 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

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