Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

October 7, 2020 updated by: Mehran Dadras, MD, Ruhr University of Bochum

Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie

This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44789
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.

Exclusion Criteria:

  • No primary skin closure.
  • Skin infection in area of operation (e.g. acne inversa).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes.
Other: Wound dressing with adhesive tapes
Regular adhesive wound tapes are applied over the closed skin.
Experimental: Incisional negative pressure group
After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days.
Other: Incisional negative pressure wound therapy
A negative pressure dressing is applied to the skin incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of drainage fluid
Time Frame: up to 14 days postoperatively
Measurement of total fluid amounts in drains and negative pressure device
up to 14 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complications
Time Frame: 3 months
Assessment of course of wound healing, necessary operative revisions, seroma formation
3 months
Wound margin perfusion
Time Frame: 5 days postoperatively
Measurement with laser doppler
5 days postoperatively

Collaborators and Investigators

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

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Björn Behr, MD, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
  • Study Director: Mehran Dadras, MD, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

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)

December 1, 2018

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-6411-BR

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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