Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

March 17, 2021 updated by: Dr. Balázs Bánky PhD, St. Borbala Hospital

Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.

NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.

In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.

Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.

Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).

A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.

Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Tatabánya, Hungary, 2800
        • St. Borbala Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
  • Surgical wound type III or IV..

Exclusion Criteria:

  • Patients not giving informed consent.
  • Patients requiring open abdominal wound care.
  • Patients with abdominal wall malignancy,
  • Patients with peritoneal carcinomatosis,
  • Patients who are planned for second look laparotomy within 5 days,
  • Patients with less thank 3 month life expectancy.
  • Patients who are operated with existing wound infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ciNPWT

Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation.

Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed.
Device: Prophylactic negative pressure wound dressing after laparotomy
Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.
NO_INTERVENTION: Traditional wound dressing
Control group with traditional, dry laparotomy wound dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 30 days
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full thickness abdominal wall dehiscence, requiring re-operation
Time Frame: 30 days
Full thickness abdominal wall dehiscence, requiring re-operation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Borbala Hospital

Collaborators

Semmelweis University
Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest
Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár
Institute of Surgery, University of Debrecen
Department of Surgery, University of Szeged
Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest
Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely
Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét
Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen
Department of Surgery, Szent Rókus Kórház, Baja
Department of Surgery, St. Borbala hospital, Tatabanya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

October 21, 2018

First Submitted That Met QC Criteria

October 21, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGYÉI/15347-9/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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