BPO vs Hibiclens Soap for Surgical Preparation

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation

Conditions
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Propionibacterium Acnes

Intervention / Treatment
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* Drug: Benzoyl Peroxide 10% Bar
* Drug: Chlorhexidine Gluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hibiclens Soap<br> | Drug: Chlorhexidine Gluconate<br>* Patients will wash with Chlorhexidine Gluconate<br>|
| Experimental: BPO Soap<br> | Drug: Benzoyl Peroxide 10% Bar<br>* Patients will wash with Benzoyl Peroxide 10% Bar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days. | Day of Surgery | 
| Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: no growth= 0, broth only= 0.1, one colony only= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days. | Day of Surgery |