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Open Access 01-12-2016 | Study protocol

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Authors: Catherine Arundel, Hannah Buckley, Emma Clarke, Nicky Cullum, Stephen Dixon, Jo Dumville, Caroline Fairhurst, Anna Firth, Eileen Henderson, Karen Lamb, Elizabeth McGinnis, Angela Oswald, Pedro Saramago Goncalves, Marta Soares, Nikki Stubbs, David Torgerson, Ian Chetter

Published in: Trials | Issue 1/2016

Abstract

Background

Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT.

Methods

This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months.

Discussion

This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI.

Trial registration

Clinical Trial Registry: ISRCTN12761776, registered on 10 December 2015 – retrospective registration.

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Title: Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial
Authors: Catherine Arundel
Hannah Buckley
Emma Clarke
Nicky Cullum
Stephen Dixon
Jo Dumville
Caroline Fairhurst
Anna Firth
Eileen Henderson
Karen Lamb
Elizabeth McGinnis
Angela Oswald
Pedro Saramago Goncalves
Marta Soares
Nikki Stubbs
David Torgerson
Ian Chetter
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1661-1

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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