Trial Status: Recruitment closed: April 2018
WHIST is funded by the NIHR Health Technology Assessment programme.
HTA Project Reference: 14/199/14
WHIST - Wound Healing In Surgery for Trauma
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 arms and 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 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 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. 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.
The study protocol publication can be found here.
The statistical analysis plan publication can be found here.