N/A
N=242
Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
Postoperative Infection · Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT03926208 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Bacterial Culture Growth — 32; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soak and Scrub (Procedure); Clorhexadine scrub (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Culture Growth |
32; 33 | — |
Summary
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak & scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Patient requires a foot or ankle operative procedure
- Patient provides informed consent
Exclusion Criteria
- Patient refuses
- Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent
Data sourced from ClinicalTrials.gov (NCT03926208). 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.