A randomised controlled trial of standard-of-care wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb
A patient with an open fracture of the lower limb will be randomly assigned to receive either standard wound care or a vacuum-sealed dressing called negative pressure wound therapy. This matters because open fractures carry a high risk of deep infection, which can lead to prolonged treatment, repeated surgery, or amputation. Surgeons lack clear evidence on whether negative pressure wound therapy reduces infection rates better than conventional dressings after the initial wound cleaning. The trial will compare the two approaches directly, tracking complications, surgical interventions, and long-term infection outcomes. If negative pressure therapy proves superior, it could become the new standard of care in NHS trauma units, reducing the burden of chronic infection and repeat operations for patients with these severe injuries. If it does not, the NHS can avoid spending on a more expensive technology without proven benefit. The results will directly inform clinical guidelines for managing open lower-limb fractures, a common and serious orthopaedic emergency.
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Feasibility summary The feasibility phase will take place in 5 centres over a period of 6 months. The trial will run as described below, with the addition of a qualitative sub-study assessing patients’ experience of giving consent for the trial and the acceptability of the trial procedures to patients and staff. Screening logs will be kept at each site to determine the number of patients assessed for eligibility and reasons for any exclusion. In addition, the number of eligible and recruited patients, and the number of patients who withdraw, will be recorded. Main RCT summary All adult patients presenting at the trial centres within 72 hours of sustaining an open fracture of the lower limb are potentially eligible to take part in the trial. Inclusion within the trial depends on the severity the wound associated with the fracture; Gustilo and Anderson Grade 2 and 3 injuries will be included. A randomisation sequence, stratified by trial centre, patient age (as a surrogate for bone density) and Gustilo and Anderson grade, will be administered via a secure web-based service. The allocation will be to either standard wound management or negative pressure wound therapy applied at the end of the initial surgical debridement of the wound. The patients will have clinical follow-up in the local fracture clinic up to a minimum of 12 months as per standard NHS practice after this injury. Functional and quality of life outcome data will be collected using the DRI, SF36 and EQ-5D questionnaires at 3 months, 6 months, 9 months and 12 months post-operatively. These postal questionnaires will be administered centrally by a data administrator. In addition information will be requested with regards to resource use and any late complications or surgical interventions related to their injury with specific note of continuing treatment for deep infection.
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