Pre-operative Alcohol Skin Solutions in Fractured Extremities

More than one million Americans suffer an extremity fracture (broken bone in the arm, leg, or
pelvis) that requires surgery each year. Approximately 5% (or 50,000) of surgical fracture
patients develop a surgical site infection (SSI), which is twice the rate among most surgical
patients and nearly five times the rate among patients undergoing elective orthopaedic
surgeries (e.g. joint replacement). Patients who develop a SSI after their fracture fixation
surgery experience a long and difficult treatment pathway. Researchers have identified that
when a fracture patient experiences a SSI, they typically undergo at least two additional
surgeries to control the infection, spend a median of 14 additional days in the hospital, and
have significantly lower health related quality of life (HRQL). Similarly, results from the
recently completed Fluid Lavage of Open Wounds (FLOW) trial confirmed that patients who had a
SSI, or another complication, that required an additional surgery reported significantly
lower physical and mental HRQL in the 12 months following their fracture compared to patients
who did not experience a SSI. In the most severe cases, when a SSI cannot be controlled, a
limb amputation becomes necessary.

Open fractures, closed lower extremity fractures, and pelvic fractures represent some of the
most severe musculoskeletal injuries. Due to their high-energy mechanisms, these fractures
are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes.
The FLOW trial of 2,447 open fracture patients reported a 13.2% incidence of open
fracture-related reoperations; Closed fractures of the lower extremity are also at high risk
of complications, particularly when compared to closed upper extremity fractures. For
example, the rate of SSI in closed tibial plateau and plafond fractures range from 5.6 -
11.9%, although some cohort studies have reported infection rates as high as 25.0%. This is
contrast with SSI rates of <5% for common upper extremity fractures like humeral shaft,
forearm, or distal radius fractures. This is further illustrated in a series of 214 deep
orthopaedic fracture infections, in which 58% occurred in the tibia and ankle, and only 10%
occurred anywhere in the upper extremity. Finally, pelvic fractures are associated with some
of the most challenging SSIs to treat among closed fractures because of their propensity to
gram negative organisms and limitations in reconstruction options post-infection. Ultimately,
infectious complications in these fracture populations lead to prolonged morbidity, loss of
function, and potential limb loss.

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 the radial and 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
non-participating hospital or clinic (as applicable).

4. Open fracture managed outside of the participating orthopaedic service (e.g., hand
fracture managed by plastic surgeon).

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. Problems, in the judgment of study personnel, with maintaining follow-up with the
patient.

13. Prior enrollment in the PREP-IT trial.

14. Enrolled in the PREPARE closed cohort

15. Excluded as per 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 3 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 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. Problems, in the judgment of study personnel, with maintaining follow-up with the
patient.

12. Prior enrollment in a PREP-IT trial

13. Enrolled in the PREPARE open cohort

14. Excluded as per sampling strategy