Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery

NCT ID: NCT02901405

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-18

Study Completion Date

2020-04-28

Brief Summary

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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

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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

Conditions

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Sarcoma Wound Infection

Keywords

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sarcoma infection negative pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Negative Pressure Wound Therapy

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

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy (ActivVAC, KCI)

Intervention Type DEVICE

Standard dressings

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

Group Type ACTIVE_COMPARATOR

Standard dressings

Intervention Type DEVICE

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

Interventions

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Negative Pressure Wound Therapy (ActivVAC, KCI)

Intervention Type DEVICE

Standard dressings

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjay Gupta, MBBS

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

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Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GN15OR558

Identifier Type: -

Identifier Source: org_study_id