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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986111
• Other study ID #: B-2007/627-003
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2021
• Source: Seoul National University Bundang Hospital
• Contact: Jeehye Lee, MD
• Phone: +82-31-787-6555
• Email: jlee0531[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection
• Wound Heal
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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