Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

November 16, 2021 updated by: NHS Greater Glasgow and Clyde

Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision

This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.

Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation

Study Type

Interventional

Enrollment (Actual)

17

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

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults undergoing primary soft tissue sarcoma excision which is primarily closed.

Exclusion Criteria:

  • Unable to consent
  • Children
  • Post radiation sarcomas or sarcoma in presence of active infection
  • Multiple metastatic disease
  • Presence of Endoprosthesis

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Negative Pressure Wound Therapy
120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.
Device: Negative Pressure Wound Therapy (ActivVAC, KCI)
Active Comparator: Standard dressings
Absorbant dressings applied in a standard fashion, i.e. only changed as necessary
Device: Standard dressings
Current absorbent dressing is 'tegaderm with absorbent pad' (3M)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (proportion)
Time Frame: 30 days
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wound dryness (nominal scale)
Time Frame: 30 days
Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)
30 days
Delay to discharge form hospital (nominal scale)
Time Frame: 30 days
Number of additional hospital stays attributable to wound issues
30 days
Adverse events (count)
Time Frame: 30 days
Number of unanticipated events
30 days
Cost analysis (comparative nominal scale in £)
Time Frame: 30 days
Cost analysis to evaluate potential offset of costs for NPWT
30 days

Collaborators and Investigators

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

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Sanjay Gupta, MBBS, NHS Greater Glasgow and Clyde

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)

October 18, 2016

Primary Completion (Actual)

April 28, 2020

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 10, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN15OR558

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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