Back to resultsNegative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
Primary Purpose
Sarcoma, Wound Infection
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy (ActivVAC, KCI)
Standard dressings
Sponsored by
About this trial
This is an interventional prevention trial for Sarcoma focused on measuring sarcoma, infection, negative pressure
Eligibility 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
Sites / Locations
- Glasgow Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Negative Pressure Wound Therapy
Standard dressings
Arm Description
120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.
Absorbant dressings applied in a standard fashion, i.e. only changed as necessary
Outcomes
Primary Outcome Measures
Surgical Site Infection (proportion)
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
Secondary Outcome Measures
Time to wound dryness (nominal scale)
Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)
Delay to discharge form hospital (nominal scale)
Number of additional hospital stays attributable to wound issues
Adverse events (count)
Number of unanticipated events
Cost analysis (comparative nominal scale in £)
Cost analysis to evaluate potential offset of costs for NPWT
Full Information
NCT ID
NCT02901405
First Posted
September 1, 2016
Last Updated
November 16, 2021
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT02901405
Brief Title
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
Official Title
Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was unable to meet recruitment targets
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Wound Infection
Keywords
sarcoma, infection, negative pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.
Arm Title
Standard dressings
Arm Type
Active Comparator
Arm Description
Absorbant dressings applied in a standard fashion, i.e. only changed as necessary
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy (ActivVAC, KCI)
Intervention Type
Device
Intervention Name(s)
Standard dressings
Intervention Description
Current absorbent dressing is 'tegaderm with absorbent pad' (3M)
Primary Outcome Measure Information:
Title
Surgical Site Infection (proportion)
Description
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to wound dryness (nominal scale)
Description
Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)
Time Frame
30 days
Title
Delay to discharge form hospital (nominal scale)
Description
Number of additional hospital stays attributable to wound issues
Time Frame
30 days
Title
Adverse events (count)
Description
Number of unanticipated events
Time Frame
30 days
Title
Cost analysis (comparative nominal scale in £)
Description
Cost analysis to evaluate potential offset of costs for NPWT
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Gupta, MBBS
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
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