Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

NHS Trust

Status: Terminated

Conditions: Sarcoma; Wound Infection

Treatments: Device: Negative Pressure Wound Therapy (ActivVAC, KCI); Device: Standard dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT02901405

GN15OR558

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.

Treatment:

Device: Negative Pressure Wound Therapy (ActivVAC, KCI)

Standard dressings

Active Comparator group

Description:

Absorbant dressings applied in a standard fashion, i.e. only changed as necessary

Treatment:

Device: Standard dressings