Determining the feasibility of a randomised controlled trial of implanting local antibiotic carriers in the management of complex orthopaedic trauma (IMPACT)

Research summary

Broken bones can happen to anyone, at any age. Sometimes an operation is needed to hold the broken bones together while they heal. One of the complications of this operation is an infection in the area where the bone has been fixed. These are called fracture-related infections (FRI). They can be serious, and usually require more operations. Some surgeons use local antibiotic carriers during the operation to try to lower the risk of FRIs. These are placed directly into the fracture and slowly release antibiotics into the injured area. However, not all surgeons use them, and we do not yet have strong research evidence showing whether they work better than standard care. A large clinical trial would help answer this question, but before doing this, we need to check whether such a trial is possible. The IMPACT study is a feasibility study, which is designed to see whether a future, larger trial can be successfully carried out. Adults with certain types of fractures that have a higher risk of infection will be invited to take part. Those who agree will be randomly allocated to receive either the local antibiotic carrier or standard care during their planned surgery. The IMPACT study will include 76 participants across at least 3 NHS hospitals in England. We will collect information on how many people agree to participate, whether the treatment is acceptable to patients and surgeons, how well follow-up works, and whether we can collect the right information about recovery. The results will help us plan a larger study to guide future NHS practice.

Principal Investigator

Mr David Noyes

Contact us

Email: Kathryn.Lewis@ouh.nhs.uk

IRAS number

331952