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

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ClinicalTrials.gov Identifier: NCT04088162
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Michał Pędziwiatr, Jagiellonian University

Tracking Information
First Submitted Date  ICMJE August 31, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE January 1, 2016
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • 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 .
  • 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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • 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
  • Postoperative Hospital Stay (LOS) [ Time Frame: 90 days ]
    Secondary endpoints is described as postoperative length of hospital stay (LOS)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery
Official Title  ICMJE 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.
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 .

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stoma Ileostomy
  • Surgical Wound
  • Negative Pressure Wound Therapy
  • Postoperative Wound Infection
Intervention  ICMJE Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA
Other Name: Postop. NPWT, Postoperative VAC
Study Arms  ICMJE
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mateusz Wierdak, MD +48609098599 mateusz.wierdak@uj.edu.pl
Contact: Michał Pedziwiatr, As. prof. +48608552323 michal.pedziwiatr@uj.edu.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04088162
Other Study ID Numbers  ICMJE JagiellonianU-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michał Pędziwiatr, Jagiellonian University
Study Sponsor  ICMJE Michał Pędziwiatr
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jagiellonian University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP