NCT04088162

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

Completed NA Last updated 20 March 2024

What this trial tests

NA trial testing Postoperative Negative Pressure Wound Therapy KCI NANOVA in Stoma Ileostomy in 70 participants. Completed in 1 January 2021.

Timeline

1 January 2016

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	Michał Pędziwiatr
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	70
Start date	1 January 2016
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	2 locations across Poland

Drugs / interventions tested

• Postoperative Negative Pressure Wound Therapy KCI NANOVA

Conditions studied

• Stoma Ileostomy — all drugs for Stoma Ileostomy →
• Surgical Wound — all drugs for Surgical Wound →
• Negative Pressure Wound Therapy — all drugs for Negative Pressure Wound Therapy →
• Postoperative Wound Infection — all drugs for Postoperative Wound Infection →

Sponsor

Michał Pędziwiatr

Who can join

18 and older, any sex, with Stoma Ileostomy or Surgical Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Negative pressure wound therapy for surgical wounds healing by primary closure.
   Norman G, Shi C, Goh EL, Murphy EM, et al · · 2022 · cited 71× · PMID 35471497 · DOI 10.1002/14651858.cd009261.pub7
2. Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial.
   Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, et al · · 2021 · cited 32× · PMID 33161523 · DOI 10.1007/s10151-020-02372-w