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

NCT ID: NCT04088162

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2021-01-01

Brief Summary

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 .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Dressing

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Postoperative NPWT dressing

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.

Group Type: EXPERIMENTAL

Postoperative Negative Pressure Wound Therapy KCI NANOVA

Intervention Type: DEVICE

Interventions

Postoperative Negative Pressure Wound Therapy KCI NANOVA

Intervention Type: DEVICE

Other Intervention Names

Postop. NPWT, Postoperative VAC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michał Pędziwiatr

OTHER

Sponsor Role: lead

Responsible Party

Michał Pędziwiatr

Asoc. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oddział kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej

Poznan, Wielkopolska, Poland

2nd Department of General Surgery, Jagiellonian University

Krakow, , Poland

Countries

Poland

References

Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, Kolodziejska K, Nowakowski M, Vongsurbchart T, Pedziwiatr M. Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial. Tech Coloproctol. 2021 Feb;25(2):185-193. doi: 10.1007/s10151-020-02372-w. Epub 2020 Nov 7.

Reference Type: DERIVED

PMID: 33161523 (View on PubMed)

Other Identifiers

JagiellonianU-05

Identifier Type: -

Identifier Source: org_study_id