Status:
COMPLETED
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
McMaster University
United States Department of Defense
Conditions:
Surgical Site Infection
Unplanned Fracture-Related Reoperation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 te...
Eligibility Criteria
Inclusion
- The inclusion criteria are:
- Patients 18 years of age or older.
- Open fracture of the appendicular skeleton.
- Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).
- Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained.
- Patient enrolled within 3 weeks of their fracture.
- The exclusion criteria are:
- Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
- Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.
- Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Burns at the fracture site.
- Incarceration.
- Expected injury survival of less than 90 days.
- Terminal illness with expected survival less than 90 days.
- Previous enrollment in a PREP-IT trial.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Excluded due to sampling strategy.
Exclusion
Key Trial Info
Start Date :
April 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
1638 Patients enrolled
Trial Details
Trial ID
NCT03385304
Start Date
April 8 2018
End Date
June 27 2022
Last Update
March 31 2023
Active Locations (15)
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1
The CORE Institute / Banner University Medical Center
Phoenix, Arizona, United States, 85006
2
Banner - University Medical Center Tucson
Tucson, Arizona, United States, 85721
3
University of California San Francisco
San Francisco, California, United States, 94143
4
University of Florida
Gainesville, Florida, United States, 32611