Phase 4
N=1,638
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
Surgical Site Infection · Unplanned Fracture-Related Reoperation · Open Appendicular Fracture
Bottom Line
View on ClinicalTrials.gov: NCT03385304 ↗Enrolled (actual)
1,638
Serious AEs
44.8%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) — 13; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 10% povidone-iodine (1% free iodine) in purified water (Drug); 4% chlorhexidine gluconate (CHG) in purified water (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) |
13; 7 | — |
| PRIMARY Number of Participants With a Deep Incisional or Organ/Space Infection |
46; 51 | — |
| SECONDARY Number of Participants With an Unplanned Fracture-Related Reoperation |
118; 115 | — |
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT03385304). 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.