Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

Not Applicable

Terminated

• Conditions: Sarcoma; Wound Infection
• Interventions: Device: Standard dressings; Device: Negative Pressure Wound Therapy (ActivVAC, KCI)

• Registration Number: NCT02901405
• Lead Sponsor: NHS Greater Glasgow and Clyde

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 Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-10
• Study First Posted: 2016-09-15
• Study Start: 2016-10-18
• Primary Completion: 2020-04-28
• Study Completion: 2020-04-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dressings	Standard dressings	Absorbant dressings applied in a standard fashion, i.e. only changed as necessary
Negative Pressure Wound Therapy	Negative Pressure Wound Therapy (ActivVAC, KCI)	120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection (proportion)	30 days	As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines

Secondary Outcome Measures

Name	Time	Method
Delay to discharge form hospital (nominal scale)	30 days	Number of additional hospital stays attributable to wound issues
Adverse events (count)	30 days	Number of unanticipated events
Cost analysis (comparative nominal scale in £)	30 days	Cost analysis to evaluate potential offset of costs for NPWT
Time to wound dryness (nominal scale)	30 days	Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)

Trial Locations

Locations (1)

Glasgow Royal Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom