Achten, Juul, Parsons, Nicholas R., Bruce, J. (Julie), Petrou, Stavros, Tutton, Elizabeth, Willett, Keith, Lamb, S. E. (Sallie E.) and Costa, Matthew L. (2015) Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb : UK wound management of open lower limb fractures (UK WOLFF). BMJ Open, 5 (9). pp. 1-10. e009087. doi:10.1136/bmjopen-2015-009087

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Abstract

Introduction:
Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures.

Methods and analysis:
All adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12 months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patients’ experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12 months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12 months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1 year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05.

Ethics and dissemination:
Ethical approval was given by NRES Committee West Midlands—Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing > Royal College of Nursing Research Institute (RCN) (- July 2017) Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Fractures, Open -- Treatment
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	22 September 2015
Dates:	Date Event 22 September 2015 Published 20 July 2015 Accepted 16 June 2015 Submitted
Date of first compliant deposit:	11 December 2015
Date of first compliant Open Access:	11 December 2015
Volume:	5
Number:	9
Number of Pages:	10
Page Range:	pp. 1-10
Article Number:	e009087
DOI:	10.1136/bmjopen-2015-009087
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	National Institute for Health Research (Great Britain) (NIHR)
Grant number:	HTA10/57/20 (NIHR)

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