Title: WHIST - Wound Healing In Surgery for Trauma
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Background – ‘Major Trauma’ occurs when a patient sustains very serious injuries to one part of the body or injuries to several parts of the body at the same time. It is often caused by road traffic accidents or falls from height. Major trauma is the leading cause of death in people under 45 years and a significant cause of short and long-term disability. The National Audit Office estimate that trauma costs our health service between £0.3 and £0.4 billion a year in early hospital treatment. However, because major trauma affects young working people in particular, the cost to society due to lost economic output is between £3.3 billion and £3.7 billion. Most patients with major trauma have injuries to their legs, and many of these require surgery to fix broken bones etc. However, in major trauma, the rate of infection in surgical wounds may be as high as 40%. This is because there is usually extensive damage to the muscles and other tissues in the leg due to the injuries and before the surgery; the damaged tissues are less able to resist the bacteria which cause infections. Deep infection around the bone causes long-term problems for the patient, often required repeated operations and can even lead to amputation of the lower limb. One of the factors which may reduce the risk of infection in the surgical wounds of major trauma patients is the type of dressing applied over the wound at the end of the operation. New wound dressings are being developed which may reduce the risk of infection, but these are often introduced into the NHS without formal testing in research projects. Negative pressure wound therapy (NPWT) has provided promising early results in patients with surgical wounds associated with major trauma. NPWT involves applying gentle suction to the surface of the wound as it heals. We propose a large randomised clinical trial comparing NPWT with standard dressings for patients with surgical wounds associated with major trauma to the lower limb. Methods - All adult patients sustaining major trauma, and who require surgery for their limb injuries, will be able to take part in the trial. A total of 1540 patients will take part at several hospitals in the UK. Half of the patients will receive standard wound management and the other half negative pressure wound therapy (NPWT). The treatment for each individual patient will be decided by chance using a computer programme. The patients will be kept under review in the hospital clinics for a minimum of 6 months, which is the usual NHS practice after such injuries. We will record any signs of infection and take a photograph to assess wound healing. We will ask the patients themselves to rate the quality of their wound healing. We will also use questionnaires to measure the patients’ function and quality of life at 30 days, 3 months and 6 months after the injuries. We will then follow the patients recovery on an annual basis for 5 years. The main analysis of the trial will investigate differences in the number of patients who develop a wound infection in the 30 days after their injuries. This will allow us to determine whether NPWT reduces the rate of infection. We will also investigate the costs of the different types of wound dressing.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS