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NCT02901405 Clinical Trial

Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02901405
Other study ID # GN15OR558
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 18, 2016
Est. completion date April 28, 2020

Study information
Verified date November 2021
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date April 28, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Negative Pressure Wound Therapy (ActivVAC, KCI)

• Standard dressings
Current absorbent dressing is 'tegaderm with absorbent pad' (3M)

Locations
Country Name City State
United Kingdom Glasgow Royal Infirmary Glasgow Scotland

Sponsors (1)
Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Site Infection (proportion) As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines 30 days
Secondary 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
Secondary Delay to discharge form hospital (nominal scale) Number of additional hospital stays attributable to wound issues 30 days
Secondary Adverse events (count) Number of unanticipated events 30 days
Secondary Cost analysis (comparative nominal scale in £) Cost analysis to evaluate potential offset of costs for NPWT 30 days
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