WHIST - Wound Healing In Surgery for Trauma
Research type
Research Study
Full title
WHIST - Wound Healing In Surgery for Trauma. A Randomised Controlled Trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb
IRAS ID
192580
Contact name
Matthew Costa
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN12702354
Duration of Study in the UK
7 years, 3 months, 30 days
Research summary
Major trauma, is the leading cause of death in people under 45 years and a significant cause of short and long-term disability. 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; the damaged tissues are less able to resist the bacteria which cause infections. \nOne 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. 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.\nA 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 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 also measure the patients’ function and quality of life at 30 days, 3 and 6 months after the injuries. We intend to follow their recovery path for 5 years.
LAY SUMMARY OF STUDY RESULTS:
We found no evidence of a difference in the rate of surgical site infection between those patients randomised to negative-pressure wound therapy and those patients randomised to standard wound dressings. There was no difference in the rate of other wound healing complications or in the patients' self-report of disability, health-related quality of life or scar healing. Negative-pressure wound therapy is very unlikely to be cost-effective for the NHS. In conclusion, and contrary to previous reports, the findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to their legs.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0006
Date of REC Opinion
5 Feb 2016
REC opinion
Favourable Opinion