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

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

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection; Wound Heal
• Intervention / Treatment: Procedure: Linear skin closure with wound drain; Procedure: Purse-string skin closure with negative pressure wound therapy

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeehye Lee, MD; Phone Number: +82-31-787-6555; Email: jlee0531@snubh.org

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Duck-Woo Kim, MD PhD; Phone Number: +82-31-787-7101; Email: kdw@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Linear skin closure with wound drain; 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.
Active Comparator: 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.	Procedure: Purse-string skin closure with negative pressure wound therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Duck-Woo Kim, MD PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Wounds and Injuries; Surgical Wound Infection
• Other Study ID Numbers: B-2007/627-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No