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

NCT04088162 | Completed

• 1 other identifier: JagiellonianU-05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Incidence of wound management complications

  Primary endpoint is described as a reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation. Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .

  90 days

• Incidence of wound management complications in groups treated with different types of postopNPWT

  The primary endpoint is described as a comparison of reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation between 3 different postopNPWT devices (KCI NANOVA, Smith\&Naphiew PICO and Gynadyne XLR 8) . Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .

  90 days

Secondary Outcomes (3)

• Surgical Site Infections (SSI) Incidence

  90 days

• Postoperative Hospital Stay (LOS)

  90 days

• Complete wound healing (CWH) time

  90 Days

Study Arms (2)

Standard Dressing

NO INTERVENTION

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

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.

Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA

Interventions

Postoperative Negative Pressure Wound Therapy KCI NANOVA DEVICE

Also known as: Postop. NPWT, Postoperative VAC

Postoperative NPWT dressing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michał Pędziwiatr: lead

Study Sites (2)

Oddział kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej

Poznan, Wielkopolska, 60-355, Poland

Location

2nd Department of General Surgery, Jagiellonian University

Krakow, 31-501, Poland

Location

Related Publications (1)

• 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.

  PMID: 33161523 DERIVED

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asoc. Prof.

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 12, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 20, 2024

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)