Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures



Status:Enrolling by invitation
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:April 3, 2018
End Date:September 2021

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Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

The prevention of infection is the single most important goal influencing peri-operative care
of patients with open fractures. Standard practice in the management of open 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 open
fracture surgery.


The 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)
(e.g., 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 exclusion criteria are:

1. Patients that did not or will not receive the allocated pre-operative surgical
preparation solution due to a medical contraindication.

2. Received previous surgical debridement or management of their open fracture at a
non-participating hospital or clinic.

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

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. Previously enrolled in the Aqueous-PREP trial.
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7000 Fannin St
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