Extrait

Background and study aims We are carrying out a study of patients who are undergoing an elective hip or knee replacement to compare different sutures used to close the surgical site wound. Our goal is to establish if the use of a triclosan coated suture will reduce the rate of surgical site infection. We will look at a number of patient characteristic such as age, gender, rates of infection, timing of surgery, and other characteristics. The study's findings should help to improve the well being of patients undergoing a hip and knee replacement in the UK, England and enhance the country's research base in orthopaedic infection. Who can participate? The study aims to recruit about 2600 patients, age > 18 years from 3 centers within Northumbria NHS trust. This study is based in a hospital setting. What does the study involve? Patients will be invited to participate in a study comparing two different sutures hip and knee replacement. Patients will be assigned to one of two groups. A process called ‘randomisation’, which is like a coin toss, will allocate the suture given to the patient based on a monthly assignment. Group 1 will receive a standard suture (that used in normal practice) and group 2 will receive triclosan-coated (antibacterial action) suture (that is used in other areas of surgical practice). Both groups then have the same postoperative care and follow up. At the end of the study, we will compare the rates of surgical site infection between the groups. Patients will be given the same clinical care whether or not they are in the study. What are the possible benefits and risks of participating? The benefits of the study will potentially develop a positive change in treatment for this operation in a rigorous scientific manner. This may ultimately change management for this fracture in the NHS. There may be no difference in either group. The risk is deemed low and is essentially the risks normally associated with operative intervention. Where is the study run from? The study has been set up and is sponsored by Northumbria NHS trust UK. When is the study starting and how long is it expected to run for? Recruitment started in May 2008 and follow up is expected to complete by December 2013. Participants will be enrolled on the study until around 2600 patients have been enrolled. Who is funding the study? Johnson & Johnson Medical Ltd, UK Who is the main contact? Mr Mike Reed, [email protected] Mr Andrew Sprowson, [email protected]

Critère d'inclusion

• Surgical site infection / orthopaedics / hip replacement / knee replacement

Liens

• ictrp
• isrctn