Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02901405

Enrollment

Registered

2016-09-15

Start date

2016-10-18

Completion date

2020-04-28

Last updated

2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Wound Infection

Keywords

sarcoma, infection, negative pressure

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

Interventions

DEVICENegative Pressure Wound Therapy (ActivVAC, KCI)

DEVICEStandard dressings

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026