Topical Treatment and Prevalence of P. Acnes

Study Overview
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Brief Summary
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This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.

Detailed Description
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P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.

Official Title
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Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Clindamycin 1% Gel
* Drug: Benzoyl peroxide 5% gel
* Drug: BenzaClin 5%-1% Topical Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteer age > 18 Exclusion Criteria: history of antibiotic use in the last month active acne on the back non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No topical treatment | |
| Experimental: Clindamycin alone<br>topical clindamycin alone using Clindamycin 1% Gel | Drug: Clindamycin 1% Gel<br>* topical clindamycin<br>|
| Experimental: Benzoyl peroxide alone<br>topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel | Drug: Benzoyl peroxide 5% gel<br>* topical benzoyl peroxide<br>|
| Experimental: Clindamycin and benzoyl peroxide<br>Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel | Drug: BenzaClin 5%-1% Topical Gel<br>* Topical clindamycin and benzoyl peroxide together<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms. | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propionibacterium Acnes, Surgical Site Infection, Shoulder