Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Surgical Site Infection (proportion)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults undergoing primary soft tissue sarcoma excision which is primarily closed.
Exclusion Criteria
- •Unable to consent
- •Post radiation sarcomas or sarcoma in presence of active infection
- •Multiple metastatic disease
- •Presence of Endoprosthesis
Outcomes
Primary Outcomes
Surgical Site Infection (proportion)
Time Frame: 30 days
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
Secondary Outcomes
- Delay to discharge form hospital (nominal scale)(30 days)
- Adverse events (count)(30 days)
- Cost analysis (comparative nominal scale in £)(30 days)
- Time to wound dryness (nominal scale)(30 days)