Woman and Man
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Extract
Background and study aims Fractures of the legs are extremely common injuries in both the civilian and military populations. The majority of these injuries are 'closed' i.e. the skin around the fracture is intact. However, if the fracture is 'open', such that the barrier provided by the skin is breached, then the broken bone is exposed to contamination from the environment. This may lead to infection and disability. The management of open fractures requires the removal of all contaminated tissue and washout of the wound in the operating theatre. Once the wound is clean, a dressing is applied. The standard treatment is a sterile dressing that is applied to the exposed area. Negative-pressure wound therapy (NPWT) is an alternative form of dressing where a foam is laid onto the wound which is attached to a pump which creates a partial vacuum. This negative-pressure removes blood and ooze from the area of the wound, thereby potentially reducing the risk of infection. Patients will be placed at random into one of the two wound management groups: standard versus NPWT and asked to complete questionnaires at 3, 6, 9 and 12 months following their injury. The study will provide us with information which may help improve the treatment of patients with similar injuries in the future. Who can participate? All patients over 16 years who present with an open fracture of the leg will potentially be eligible to take part. What does the study involve? All patients will be followed up carefully to make sure that their fracture is healing and there is no sign of infection. The only additional commitment we ask is for questionnaires to be completed at 3, 6, 9 and 12 months following the injury. What are the possible benefits and risks of participating? There are no specific risks of having one type of wound dressing or the other. The risks of the injury and the surgery are the same for both groups of patients in the study and are the same as for patients who are not taking part in the study. Both standard dressings and suction dressings are used across the NHS for patients with an open fracture of the leg so there is no specific advantage to you for taking part in the study. However, the information we get from this study may help us to improve treatment for future patients with similar injuries. Where is the study run from? Warwick Clinical Trials Unit at the University of Warwick coordinates the study and over 20 hospitals across the country are taking part. When is the study starting and how long is it expected to run for? April 2012 to March 2017. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK) Who is the main contact? Miss Jaclyn Brown [email protected]
Inclusion criteria
- Open fractures of the lower limb