Tourniquets are commonly used during ankle fracture fixation surgery. This is a device which is applied around the thigh and stops blood flowing through the leg during the operation. Some surgeons believe it helps reduce intraoperative blood loss and improves their field of view, reducing operative time. However, tourniquets have been associated with various adverse effects such as increased pain, and risk of blood clot formation inside the deep veins of the leg (which can occasionally break off and travel to the lungs). Tourniquets also reduce the amount of oxygen being delivered to the soft tissues which might increase the risk of wound healing complications. Considering the clinical uncertainty regarding tourniquet use, a well-designed, multicentre trial addressing the flaws and limitations of previous studies is required to inform clinical practice. As a stepping stone, a feasibility trial is needed to assess factors affecting participant recruitment rate and evaluate the potential to effectively address the identified limitations in the previous studies.
Feastibility Randomised Controlled Trial (RCT): This involves recruitment of approximately 50 patients who require ankle fracture fixation surgery, in accordance with clinician’s standard clinical practice and the established indications for treatment of this injury. Patients will be randomised to surgery with or without tourniquet. This study will evaluate recruitment uptake, surgeon and patient equipoise, randomisation, blinding, and enable the estimation of an appropriately powered sample size for any future definitive trial.
Qualitative Interview study: This involves carrying out semi-structured interviews with approximately 12 participants and 12 surgeons who participated in the feasibility trial to explore experiences of their involvement in the trial to enhance the interpretation of its findings.