Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NPWT in Soft Tissue Sarcoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901405
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Sarcoma Wound Infection Device: Negative Pressure Wound Therapy (ActivVAC, KCI) Device: Standard dressings Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Surgical Site Infection (proportion) [ Time Frame: 30 days ]
    As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines


Secondary Outcome Measures :
  1. 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)

  2. Delay to discharge form hospital (nominal scale) [ Time Frame: 30 days ]
    Number of additional hospital stays attributable to wound issues

  3. Adverse events (count) [ Time Frame: 30 days ]
    Number of unanticipated events

  4. Cost analysis (comparative nominal scale in £) [ Time Frame: 30 days ]
    Cost analysis to evaluate potential offset of costs for NPWT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901405


Contacts
Layout table for location contacts
Contact: Ashish Mahendra, MBBS 01412114000 ashish.mahendra@ggc.scot.nhs.uk
Contact: Sanjay Gupta, MBBS 01412114000 sanjaygupta@doctors.org.uk

Locations
Layout table for location information
United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
NHS Greater Glasgow and Clyde

Layout table for additonal information
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02901405     History of Changes
Other Study ID Numbers: GN15OR558
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Keywords provided by NHS Greater Glasgow and Clyde:
sarcoma
infection
negative pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Wound Infection
Sarcoma
Infection
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms