The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery

Michał Pędziwiatr

Status: Completed

Conditions: Negative Pressure Wound Therapy; Surgical Wound; Stoma Ileostomy; Postoperative Wound Infection

Treatments: Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA

Study type: Interventional

Funder types: Other

Identifiers

NCT04088162

JagiellonianU-05

Details and patient eligibility

About

Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer.

Materials & Methods: Prospective, randomized study will be conducted. Patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without NPWT. The primary endpoint are incidence of wound related complications (WRC) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). The secondary endpoints are incidences of Surgical Site Infection (SSI) and length of postoperative hospital stay (LOS) and length of complete wound healing (CWH). Cost analysis will also be performed.

In first step of this study between January 2016 and December 2018 we will asses the usefulness of one of the NPWT devices (NANOVA KCI) in prevention of WHC in established group. The second part of the study will be performed in 2 centers between January 2019 and December 2021. In this step we want to compere other NPWT devices in the same application and to confirm single center outcomes .

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 or older
• Previous colorectal resection with the formation of protective ileostomy due to cancer
• Ileostomy closure surgery as an elective procedure.

Exclusion criteria

• Emergency or urgent operation
• Active infection
• Other than ileostomy closure or parastomal hernioplasty operation performed.
• Patents who within 1 week after operation will be re-operated or transferred to Intensive Care Unit or other hospital word due to noninfectious complications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Standard Dressing

No Intervention group

Description:

In case of Control group. After Ileostomy closure skin will be closed by 6 to 8 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures, and sterile standard dressing will be placed.

Postoperative NPWT dressing

Experimental group

Description:

In case of NPWT group. After Ileostomy closure skin will be closed by 3 or 4 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures. Between them small sponge "tongues" 1x 0,5x2 cm were placed and over whole incision an NANOVA (KCI USA) negative pressure dressing will be placed. In control group first dressing change was made in 48 hours after operation and then every day until suture removal at 7 postoperative day. In NPWT group NANOVA dressing was taken out at 72 hours. 3 steri-streps were placed between sutures and standard sterile dressing was placed. After it dressing was changed every 24 hours until suture removal at 7 postoperative day.

Treatment:

Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA