Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial.
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.
York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK. catherine.arundel@york.ac.uk.
Catherine
0000-0003-0512-4339
C
Arundel
York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.
Hannah
H
Buckley
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Emma
E
Clarke
School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK.
Nicky
N
Cullum
Patient and Public Involvement Group Representative, Hull, UK.
Stephen
S
Dixon
School of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK.
Jo
J
Dumville
York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.
Caroline
C
Fairhurst
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Anna
A
Firth
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Eileen
E
Henderson
Leeds Community Healthcare NHS Trust, Leeds, UK.
Karen
K
Lamb
Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Elizabeth
E
McGinnis
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
Angela
A
Oswald
Centre for Health Economics, University of York, York, UK.
Pedro Saramago
PS
Goncalves
Centre for Health Economics, University of York, York, UK.
Marta
M
Soares
Leeds Community Healthcare NHS Trust, Leeds, UK.
Nikki
N
Stubbs
York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.
David
D
Torgerson
Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.|Hull York Medical School, York, UK.
Ian
I
Chetter
D002985:Clinical Protocols; D006801:Humans; D054843:Negative-Pressure Wound Therapy; D010865:Pilot Projects; D000072836:Surgical Wound / Q000503:physiopathology*; D014945:Wound Healing
Healing; Negative pressure wound therapy; Randomised controlled trial; Secondary intention; Surgical wounds