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The study was unable to meet recruitment targets
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | 120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound. |
|
| Standard dressings | Active Comparator | Absorbant dressings applied in a standard fashion, i.e. only changed as necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy (ActivVAC, KCI) | Device |
| ||
| Standard dressings |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection (proportion) | As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines | 30 days |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Gupta, MBBS | NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Royal Infirmary | Glasgow | Scotland | G31 2ER | United Kingdom |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D014946 | Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Device |
Current absorbent dressing is 'tegaderm with absorbent pad' (3M) |
|
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 |