Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Condition: Surgical Site Infection; Unplanned Fracture-Related Reoperation; Open Appendicular Fracture
MeSH terms: Surgical Wound Infection; Fractures, Bone; Fractures, Open
Intervention: 10% povidone-iodine (1% free iodine) in purified water; 4% chlorhexidine gluconate (CHG) in purified water
Intervention description: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.; Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
Intervention MeSH terms: Iodine; Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Treatment allocation will be determined using a cluster-randomized crossover trial design. 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.
Masking: Single (Outcomes Assessor)
Masking description: 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 povidone-iodine, 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.
Enrollment: 1638.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgical Site Infection; Open Fracture; Povidone-iodine; Chlorhexidine gluconate; Peri-operative Preparation Solutions

Summary:

      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.
    

Eligibility criteria:

        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. Previous enrollment in a PREP-IT trial.

         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. Excluded due to sampling strategy.