NCT02901405

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

September 1, 2016

Last Update Submit

November 16, 2021

Conditions

SarcomaWound Infection

Keywords

sarcomainfectionnegative pressure

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection (proportion)

    As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines

    30 days

Secondary Outcomes (4)

  • Time to wound dryness (nominal scale)

    30 days

  • Delay to discharge form hospital (nominal scale)

    30 days

  • Adverse events (count)

    30 days

  • Cost analysis (comparative nominal scale in £)

    30 days

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

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

Device: Negative Pressure Wound Therapy (ActivVAC, KCI)

Standard dressings

ACTIVE COMPARATOR

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

Device: Standard dressings

Interventions

Negative Pressure Wound Therapy (ActivVAC, KCI)DEVICE
Negative Pressure Wound Therapy
Standard dressingsDEVICE

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

Standard dressings

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing primary soft tissue sarcoma excision which is primarily closed.

You may not qualify if:

  • Unable to consent
  • Children
  • Post radiation sarcomas or sarcoma in presence of active infection
  • Multiple metastatic disease
  • Presence of Endoprosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

SarcomaWound InfectionInfections

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Sanjay Gupta, MBBS

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 15, 2016

Study Start

October 18, 2016

Primary Completion

April 28, 2020

Study Completion

April 28, 2020

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations

GB(1)