Extrait

Background and study aims Major trauma is where a person has sustained serious and often multiple injuries. In many cases, it is the result of traffic accidents, falls and physical violence, and is one of the most common causes of death and long-term disability in people under the age of 45. Leg injuries are particularly common in cases of major trauma, and many patients require surgery to help fix broken bones. Many patients suffer from infection in surgical sites however in victims of major trauma this is thought to be as high as 40%. This is thought to be because the extensive damage to the muscles and other tissues can make patients’ tissues less resistant to bacteria and more vulnerable to infection. 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. Wound dressings are commonly used to prevent infections of surgical sites in adults; however the type of dressing used could reduce the risk of infection. New dressings are constantly being developed, however these are often introduced into the NHS without any formal testing in research projects. Negative pressure wound therapy (NPWT) is a technique which involves applying gentle suction to the surface of the wound as it heals. The aim of this study is to test the effectiveness of NPWT in comparison to standard dressings, at reducing rates of surgical site infections in major trauma patients. Who can participate? Major trauma patients aged 16 or over who need surgery to treat a broken leg. What does the study involve? Following surgery, participants are randomly allocated to one of two groups. For participants in the first group, the surgical wounds are dressed with a NPWT dressing. This consists of a foam pad, which is connected to a mini-pump to create a partial vacuum over the wound. For participants in the second group, their surgical wounds are dressed using an ordinary dressing which does not use negative pressure. 30 days after the injury occurred, the amount of participants who have had a deep infection is recorded. At the start of the study and again at 3 and 6 months, participants complete a number of questionnaires in order to measure their level of disability and quality of life, as well as how well their wound is healing. Their long-term disability and quality of life is also measured using a questionnaire at 1, 2, 3, 4 and 5 years. What are the possible benefits and risks of participating? There are no direct risks or benefits to participants taking part in the study. Where is the study run from? John Radcliffe Hospital, Oxford (lead centre) and five other NHS hospitals in England (UK) for the pilot phase When is the study starting and how long is it expected to run for? January 2016 to April 2023 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Juul Achten [email protected]

Critère d'inclusion

• Patients with major trauma requiring surgery for a fracture to the lower limb

Liens

• isrctn
• ictrp