Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Sarcoma, Wound Infection

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy (ActivVAC, KCI)
* Device: Standard dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (proportion) | 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 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) | Number of additional hospital stays attributable to wound issues | 30 days | 
| Adverse events (count) | Number of unanticipated events | 30 days | 
| Cost analysis (comparative nominal scale in £) | Cost analysis to evaluate potential offset of costs for NPWT | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoma, infection, negative pressure