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

NCT04986111 | Unknown

• 1 other identifier: B-2007/627-003
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infection; Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Linear skin closure with wound drain

EXPERIMENTAL

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

Purse-string skin closure with negative pressure wound therapy

ACTIVE COMPARATOR

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

Interventions

Linear skin closure with wound drain PROCEDURE

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.

Linear skin closure with wound drain

Purse-string skin closure with negative pressure wound therapy PROCEDURE

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.

Purse-string skin closure with negative pressure wound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients experiencing ileostomy repair at multicenter

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Duck-Woo Kim, MD PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeehye Lee, MD

CONTACT

+82-31-787-6555; jlee0531@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 2, 2021
• Study Start: January 25, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

KR (1)