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

Overview of attention for article published in Trials, November 2016
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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
Published in
Trials, November 2016
DOI 10.1186/s13063-016-1661-1
Pubmed ID
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

Abstract

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

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Geographical breakdown

Country Count As %
Unknown 69 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 13 19%
Student > Master 9 13%
Student > Ph. D. Student 6 9%
Researcher 5 7%
Other 4 6%
Other 10 14%
Unknown 22 32%
Readers by discipline Count As %
Medicine and Dentistry 20 29%
Nursing and Health Professions 12 17%
Engineering 6 9%
Business, Management and Accounting 2 3%
Neuroscience 1 1%
Other 8 12%
Unknown 20 29%