Skip to main content
OpenTrials
Completed

NCT Number: NCT04088162

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stoma Ileostomy Infections Negative Pressure Wound Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Wound Infection Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oddział kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej, Poznan, Wielkopolska, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Negative Pressure Wound Therapy KCI NANOVA

Device

Other names: Postop. NPWT, Postoperative VAC

Primary outcomes

  1. Incidence of wound management complications

    Time frame: 90 days

    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 .

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

    Time frame: 90 days

    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 .

Secondary outcomes

  1. Surgical Site Infections (SSI) Incidence

    Time frame: 90 days

    Secondary endpoints is described as incidence of SSI. Incisional SSI diagnosis criteria included an infection that occurred within 30 days after the operation involving the skin, subcutaneous tissue, or deep soft tissue (e.g. fascia and muscle layers) at the incision site, organ or space according to the criteria of CDC and ECDC for diagnosis of SSI

  2. Postoperative Hospital Stay (LOS)

    Time frame: 90 days

    Secondary endpoints is described as postoperative length of hospital stay (LOS)

  3. Complete wound healing (CWH) time

    Time frame: 90 Days

    Secondary endpoints is described as the duration of complete wound healing (CWH). Complete wound healing was defined as complete closure of the wound without any discharge at the outpatient clinic or reported by patient.

Sponsors and collaborators

Lead sponsor

Michał Pędziwiatr

Other

Registry information

Official study title

The Use of Post-operative Negative Pressure Wound Therapy (NPWT) Dressing in the Prevention of Wound Healing Problems and Infectious Complications After Ostomy Reversal Surgery.

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2019
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.