Phase 4
N=50
BPO vs Hibiclens Soap for Surgical Preparation
Propionibacterium Acnes
Bottom Line
View on ClinicalTrials.gov: NCT04021524 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate — 25; 24; 14; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Benzoyl Peroxide 10% Bar (Drug); Chlorhexidine Gluconate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate |
25; 24; 14; 11 | — |
| PRIMARY Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate |
1.6; 1.5; 0.8; 0.8 | — |
Summary
This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).
Eligibility Criteria
Inclusion Criteria
- Male subjects
- Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
- Subjects between ages 18-89
Exclusion Criteria
- Subjects who self-report very sensitive skin
- Subjects who are sensitive to benzoyl peroxide
- Subjects who are allergic to chlorhexidine
- Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
- Subjects who had recent use of acne treatment
- Subjects who are not fluent in English.
Data sourced from ClinicalTrials.gov (NCT04021524). 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.