Phase 4
N=6,785
Pre-operative Alcohol Skin Solutions in Fractured Extremities
Surgical Site Infection · Unplanned Fracture-Related Reoperation · Open Appendicular Fracture · Closed Lower Extremity Fracture · Pelvic Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03523962 ↗Enrolled (actual)
6,785
Serious AEs
37.6%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) — 20; 27; 6; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DuraPrep (Drug); ChloraPrep (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) |
20; 27; 6; 9 | — |
| PRIMARY Number of Participants With a Deep Incisional Infection |
29; 54; 21; 20 | — |
| SECONDARY Number of Participants With an Unplanned Fracture-Related Reoperation |
164; 179; 126; 114 | — |
Summary
The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity 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 extremity fracture surgery.
Eligibility Criteria
The open fracture 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) (i.e., 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 open fracture exclusion criteria are:
- Fracture of the hand (distal to radial carpal joint).
- Patients who 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 fracture at a nonparticipating hospital or clinic (as applicable).
- Open fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).
- 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.
- 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.
- Prior or current enrollment in a PREP-IT trial.
- Enrolled in the PREPARE closed cohort.
- Excluded due to sampling strategy.
The closed fracture inclusion criteria are:
- Patients 18 years of age or older.
- Closed fracture of the lower extremity or pelvis.
- Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.).
- Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion).
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained.
- Patient enrolled within 6 weeks of their fracture.
The closed fracture exclusion criteria are:
- Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
- Received previous surgical management of their fracture at a non-participating hospital or clinic.
- Fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).
- 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.
- 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.
- Prior or current enrollment in a PREP-IT trial.
- Enrolled in the PREPARE open cohort.
- Excluded due to sampling strategy.
Data sourced from ClinicalTrials.gov (NCT03523962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.