- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901405
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G31 2ER
- Glasgow Royal Infirmary
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
|
Active Comparator: Standard dressings
Absorbant dressings applied in a standard fashion, i.e.
only changed as necessary
|
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
Sponsor
Investigators
- Principal Investigator: Sanjay Gupta, MBBS, NHS Greater Glasgow and Clyde
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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Murk NiazCompletedSurgical Site Infection | Hepatobiliary Disease | Hepatobiliary DisordersPakistan
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Zuyderland Medisch CentrumCompletedBreast Cancer | Wound Infection | Wound Complication | Wound Dehiscence | Wound NecrosisNetherlands
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St. Joseph's Healthcare HamiltonUnity Health Toronto; Ontario Ministry of Health and Long Term Care; Women's... and other collaboratorsTerminatedSkin Ulcer | Pressure UlcerCanada
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