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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sarcoma
• Wound Infection

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