Pre-operative Alcohol Skin Solutions in Fractured Extremities (PREPARE)

This is an interventional treatment trial for Surgical Site Infection focused on measuring Surgical Site Infection, Open Fracture, Lower Extremity Fracture, Pelvis; Fracture, DuraPrep, ChloraPrep, Peri-operative Preparation Solutions Read More

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.