Topical Treatment and Prevalence of P. Acnes

Phase 2

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Clindamycin 1% Gel; Drug: Benzoyl peroxide 5% gel; Drug: BenzaClin 5%-1% Topical Gel

• Registration Number: NCT03257202
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Study Start: 2017-09-11
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Results First Submitted: 2019-06-20
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-25
• Last Update Submitted: 2019-10-25
• Results First Posted: 2019-11-13
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• healthy volunteer
• age > 18

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clindamycin alone	Clindamycin 1% Gel	topical clindamycin alone using Clindamycin 1% Gel
Benzoyl peroxide alone	Benzoyl peroxide 5% gel	topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
Clindamycin and benzoyl peroxide	BenzaClin 5%-1% Topical Gel	Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms	21 days	Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

Trial Locations

Locations (1)

Keck School of Medicine of the University of Southern California; 🇺🇸 Los Angeles, California, United States