Topical Treatment and Prevalence of P. Acnes

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Surgical Site Infection

Treatments: Drug: Benzoyl peroxide 5% gel; Drug: Clindamycin 1% Gel; Drug: BenzaClin 5%-1% Topical Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03257202

HS-17-00319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Control

No Intervention group

Description:

No topical treatment

Clindamycin alone

Experimental group

Description:

topical clindamycin alone using Clindamycin 1% Gel

Treatment:

Drug: Clindamycin 1% Gel

Benzoyl peroxide alone

Experimental group

Description:

topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

Treatment:

Drug: Benzoyl peroxide 5% gel

Clindamycin and benzoyl peroxide

Experimental group

Description:

Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel

Treatment:

Drug: BenzaClin 5%-1% Topical Gel