WHIST - Wound Healing In Surgery for Trauma

Background - Major Trauma is the leading cause of death in those under 45 years and a significant cause of short- and long-term morbidity. The National Audit Office estimate that trauma costs the NHS between £0.3 and £0.4 billion a year in immediate treatment with an annual lost economic output between £3.3 billion and £3.7 billion. In 85% of major trauma, the limbs are affected. Rates of infection in limb trauma have been reported to be as high as 40%. One of the factors which may reduce the risk of surgical site infection in the surgical wounds of major trauma patients is the type of dressing applied over the incision at the end of the operative procedure. New techniques for wound management are being developed but are often implemented into the NHS without sufficient evidence. Negative pressure wound therapy (NPWT) has provided promising preliminary results in different patient groups, including patients with surgical wounds associated with major trauma. We propose a multi-centre randomised clinical trial comparing negative-pressure wound therapy with standard dressings for patients with major trauma requiring surgical incisions for the treatment of lower limb fractures. Methods - All adult patients presenting at the trial centres within 72 hours of sustaining major trauma and who require a surgical incision to treat a fractured lower limb are potentially eligible for inclusion. A randomisation sequence, stratified by trial centre, open or closed fracture at presentation, and Injury Severity Score (ISS) 9-15 vs ISS 16+ will be generated and administered via a secure web-based service. The random allocation will be to either standard wound management or negative pressure wound therapy. The patients will have clinical follow-up to a minimum of 6 months, as per standard NHS practice after such injury. Photographs of the wound and diagnosis of any infection will be taken at 30 days to assess wound healing. The quality of the surgical scar will be assessed by the patients using a validated self-reported tool. Functional and quality of life outcome data will be collected using the Disability Rating Index and EQ-5D questionnaires at 30 days, 3 months and 6 months post-injury. Patients will then be followed up annually for 5 years. Outcome questionnaires will be administered centrally by a data administrator. In addition, at the same time-points, 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. The main analysis will investigate differences in the primary outcome measure, the proportion of patients with deep infection, at 30 days post operation. The stratified randomization procedure should ensure balance in the recruiting centre and ISS score between test interventions. The economic evaluation will be conducted from the recommended NHS and personal social services (PSS) perspective. Due to the known limitations of within-trial economic evaluations, we will also construct a decision-analytical model to model beyond the parameters of the proposed trial the cost-effectiveness of negative pressure wound therapy in this clinical population.