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. TRIAL REGISTRATION NUMBER: ISRCTN33756652.

Original publication

DOI

10.1136/bmjopen-2015-009087

Type

Journal article

Journal

BMJ Open

Publication Date

22/09/2015

Volume

5

Keywords

ACCIDENT & EMERGENCY MEDICINE, ORTHOPAEDIC & TRAUMA SURGERY, WOUND MANAGEMENT, Adult, Bandages, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Female, Follow-Up Studies, Fractures, Open, Health Care Costs, Humans, Leg Injuries, Male, Middle Aged, Negative-Pressure Wound Therapy, Quality of Life, United Kingdom