Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

Sponsor

NHS Greater Glasgow and Clyde (Other)

Overall Status

Terminated

CT.gov ID

NCT02901405

Collaborator

(none)

Enrollment

Location

Arms

42.3

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Wound Infection	Device: Negative Pressure Wound Therapy (ActivVAC, KCI) Device: Standard dressings	N/A

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

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 18, 2016

Actual Primary Completion Date :

Apr 28, 2020

Actual Study Completion Date :

Apr 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Negative Pressure Wound Therapy 120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.	Device: Negative Pressure Wound Therapy (ActivVAC, KCI)
Active Comparator: Standard dressings Absorbant dressings applied in a standard fashion, i.e. only changed as necessary	Device: Standard dressings Current absorbent dressing is 'tegaderm with absorbent pad' (3M)

Arm

Intervention/Treatment

Experimental: Negative Pressure Wound Therapy

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

Device: Negative Pressure Wound Therapy (ActivVAC, KCI)

Active Comparator: Standard dressings

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

Device: Standard dressings

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glasgow Royal Infirmary	Glasgow	Scotland	United Kingdom	G31 2ER

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Investigators

Principal Investigator: Sanjay Gupta, MBBS, NHS Greater Glasgow and Clyde

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier:

NCT02901405

Other Study ID Numbers:

GN15OR558

First Posted:

Sep 15, 2016

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

Keywords provided by NHS Greater Glasgow and Clyde

sarcoma

infection

negative pressure

Additional relevant MeSH terms:

Wound Infection

Sarcoma

Study Results

No Results Posted as of Nov 26, 2021