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

Seoul National University

Status: Unknown

Conditions: Surgical Site Infection; Wound Heal

Treatments: Procedure: Linear skin closure with wound drain; Procedure: Purse-string skin closure with negative pressure wound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04986111

B-2007/627-003

Details and patient eligibility

About

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

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

Linear skin closure with wound drain

Experimental group

Description:

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.

Treatment:

Procedure: Linear skin closure with wound drain

Purse-string skin closure with negative pressure wound therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Purse-string skin closure with negative pressure wound therapy