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

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

doi:10.1186/s13063-016-1661-1

Abstract

BackgroundMost 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.MethodsThis 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.DiscussionThis 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 registrationClinical Trial Registry: ISRCTN12761776, registered on 10 December 2015 – retrospective registration.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1661-1) contains supplementary material, which is available to authorized users.

Highlights

Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips
Surgical Wounds Healing by Secondary Intention (SWHSI) present a significant management challenge as they may remain open for many months and/or require multiple, additional treatments [2]
Design This study is a pilot Randomised controlled trial (RCT) conducted in three centres to test the methods and feasibility of a full RCT of Negative Pressure Wound Therapy (NPWT) compared with usual care for SWHSI

Summary

Introduction

Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. 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. A substantial number of surgical operations are conducted in the NHS each year, with most involving an incision [1] The edges of these incisions are often held together whilst healing occurs (primary closure); many surgical wounds break open or are left open to heal (healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) present a significant management challenge as they may remain open for many months and/or require multiple, additional treatments (e.g. prolonged hospitalisation, reoperation, infection management) [2]. The device is generally only used for part of the SWHSI treatment pathway rather than to the point of healing

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Methods

Conclusion