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Topical Treatment and Prevalence of P. Acnes

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ClinicalTrials.gov Identifier: NCT03257202
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
George F. "Rick" Hatch, III MD, 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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Clindamycin 1% Gel Drug: Benzoyl peroxide 5% gel Drug: BenzaClin 5%-1% Topical Gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy volunteers
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-operative Topical Treatment and the Prevalence of Propionibacterium Acnes
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018


Arm Intervention/treatment
No Intervention: Control
No topical treatment
Experimental: Clindamycin alone
topical clindamycin alone using Clindamycin 1% Gel
Drug: Clindamycin 1% Gel
topical clindamycin

Experimental: Benzoyl peroxide alone
topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
Drug: Benzoyl peroxide 5% gel
topical benzoyl peroxide

Experimental: Clindamycin and benzoyl peroxide
Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel
Drug: BenzaClin 5%-1% Topical Gel
Topical clindamycin and benzoyl peroxide together




Primary Outcome Measures :
  1. positive growth [ Time Frame: 21 days ]
    detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL)


Secondary Outcome Measures :
  1. positive hemolysis [ Time Frame: 21 days ]
    detected presence of hemolysis on brucella agar (% hemolysis)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257202


Locations
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United States, California
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: George R Hatch, MD University of Southern California

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: HS-17-00319
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: HS-17-00319

Publications:

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Responsible Party: George F. "Rick" Hatch, III MD, Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT03257202     History of Changes
Other Study ID Numbers: HS-17-00319
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by George F. "Rick" Hatch, III MD, University of Southern California:
Propionibacterium Acnes
Surgical Site Infection
Shoulder
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Surgical Wound Infection
Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents