Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures (Aqueous-PREP)

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 4

Conditions: Unplanned Fracture-Related Reoperation; Surgical Site Infection; Open Appendicular Fracture

Treatments: Drug: 4% chlorhexidine gluconate (CHG) in purified water; Drug: 10% povidone-iodine (1% free iodine) in purified water

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03385304

HP-00078470

Details and patient eligibility

About

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.

Enrollment: 1,638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,638 participants in 2 patient groups

10% povidone-iodine (1% free iodine) in purified water

Experimental group

Description:

The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.).

Treatment:

Drug: 4% chlorhexidine gluconate (CHG) in purified water

Drug: 10% povidone-iodine (1% free iodine) in purified water

4% chlorhexidine gluconate (CHG) in purified water

Experimental group

Description:

The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.).

Treatment:

Drug: 4% chlorhexidine gluconate (CHG) in purified water

Drug: 10% povidone-iodine (1% free iodine) in purified water