Background and Significance
Fractures to the extremities (limbs) are common and very devastating to patients. Previous research suggests simple measures may have dramatic improvements in reducing surgical site infections (SSIs) following fractures. Exploratory analysis from one of our recently completed fracture studies has suggested that the type of antiseptic skin solution applied to the fractured limb in the operating room may affect outcomes. Therefore, the rationale for the proposed Pragmatic Randomized Trial Evaluating Preoperative Antiseptic Skin Solutions in Fractured Extremities (PREPARE) is the need to reduce avoidable SSIs and their negative impact on fracture patients.
In the words of our patient stakeholders, we will “determine which choice between two commonly available preoperative skin antiseptic solutions is the best for reducing infections in patients undergoing surgery with plates and screws or a rod to fix a broken bone in their limb.” Our overarching objective is to optimize the benefits of preoperative skin antisepsis by identifying the most effective prophylactic solution for surgical fracture care.
PREPARE is a pragmatic cluster-randomized crossover trial that will compare chlorhexidine gluconate in alcohol versus iodine-povacrylex in alcohol preoperative skin antiseptic solutions in 8,680 fracture patients. This clinical trial design is a novel research method in which all fracture patients treated at our 10 participating hospitals will receive the predetermined study intervention prior to being asked to participate in the study. Unlike traditional cluster-randomized trial designs, the crossover method ensures each participating hospital eventually uses both treatments. The order of treatment allocation for each hospital is randomly assigned.
All patients 16 years of age or older who present to one of our 10 participating hospitals for surgical treatment for a fracture will be screened for participation. Eligible patients must have their fracture corrected using internal fixation. Patients with multiple fractures or open fractures will also be eligible.
Our primary outcome is SSI and our secondary outcome is health-related quality of life (HRQL). Both outcomes are clinically meaningful and were chosen in direct response to the needs of our patients and stakeholders. Identification of the primary outcome, SSI, will occur as part of a patient’s standard clinical care. For patients who experience an SSI, research personnel will administer a 12-question survey to measure patient-reported HRQL. All study participants will be followed for 90 days after their fracture fixation surgery. The analysis and reporting of the results will follow the Consolidated Standards of Reporting Trials statement for reporting of cluster-randomization studies.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.