PREPARE: A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites

HP-00080639

The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery.

2018-08-21

2023-03-15

2024-12-01

Active (not recruiting)

Early phase I

8000

The open fracture inclusion criteria are: 1. Patients 18 years of age or older. 2. Open fracture of the appendicular skeleton. 3. Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.). 4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Informed consent obtained. 7. Patient enrolled within 3 weeks of their fracture. The open fracture exclusion criteria are: 1. Fracture of the hand (distal to radial carpal joint). 2. Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication. 3. Received previous surgical debridement or management of their fracture at a nonparticipating hospital or clinic (as applicable). 4. Open fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist). 5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 6. Burns at the fracture site. 7. Incarceration. 8. Expected injury survival of less than 90 days. 9. Terminal illness with expected survival less than 90 days. 10. Currently enrolled in a study that does not permit co-enrollment. 11. Unable to obtain informed consent due to language barriers. 12. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient. 13. Prior or current enrollment in a PREP-IT trial. 14. Enrolled in the PREPARE closed cohort. 15. Excluded due to sampling strategy. The closed fracture inclusion criteria are: 1. Patients 18 years of age or older. 2. Closed fracture of the lower extremity or pelvis. 3. Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.). 4. Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion). 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Informed consent obtained. 7. Patient enrolled within 6 weeks of their fracture. The closed fracture exclusion criteria are: 1. Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication. 2. Received previous surgical management of their fracture at a non-participating hospital or clinic. 3. Fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist). 4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 5. Burns at the fracture site. 6. Incarceration. 7. Expected injury survival of less than 90 days. 8. Terminal illness with expected survival less than 90 days. 9. Currently enrolled in a study that does not permit co-enrollment. 10. Unable to obtain informed consent due to language barriers. 11. Likely, problems, in the judgment of study personnel, with maintaining follow-up with the patient. 12. Prior or current enrollment in a PREP-IT trial. 13. Enrolled in the PREPARE open cohort. 14. Excluded due to sampling strategy.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Treatment allocation will be determined using a cluster-randomized crossover trial design. The open and closed fracture populations will be treated with the same allocated solution at all times during the trial. The order of treatment allocation for each orthopaedic practice will be randomly assigned using a computer-generated randomization table. Each site will start with the initially allocated study solution and eventually crossover to the other solution for their second recruitment period. This process of alternating treatments will repeat approximately every 2 months as dictated by the initial randomization.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The orthopaedic team (including the study coordinators) cannot be blinded to the treatment allocation as the antiseptic solutions are visually distinguishable and these individuals need to lead the implementation of the cluster-crossover protocol at their clinical site. The Adjudication Committee Members and data analysts will be blinded to the study treatment. All interpretation of study results will initially be done in a blinded manner by developing two interpretations of the results. One interpretation will assume treatment A is iodine povacrylex, the other interpretation will assume it is CHG. Once the data interpretations for each assumption are finalized, the data will be unblinded and the correct interpretation will be accepted.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 8000, 'type': 'ESTIMATED'}}

2023-05-09