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Topical Treatment and Prevalence of P. Acnes

NCT ID: NCT03257202

Last Updated: 2019-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-01-01

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.

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Healthy volunteers
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

No topical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Clindamycin alone

topical clindamycin alone using Clindamycin 1% Gel

Group Type EXPERIMENTAL

Clindamycin 1% Gel

Intervention Type DRUG

topical clindamycin

Benzoyl peroxide alone

topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

Group Type EXPERIMENTAL

Benzoyl peroxide 5% gel

Intervention Type DRUG

topical benzoyl peroxide

Clindamycin and benzoyl peroxide

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

Group Type EXPERIMENTAL

BenzaClin 5%-1% Topical Gel

Intervention Type DRUG

Topical clindamycin and benzoyl peroxide together

Interventions

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Clindamycin 1% Gel

topical clindamycin

Intervention Type DRUG

Benzoyl peroxide 5% gel

topical benzoyl peroxide

Intervention Type DRUG

BenzaClin 5%-1% Topical Gel

Topical clindamycin and benzoyl peroxide together

Intervention Type DRUG

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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George F. Hatch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George R Hatch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.

Reference Type BACKGROUND
PMID: 25187583 (View on PubMed)

Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.

Reference Type BACKGROUND
PMID: 19651954 (View on PubMed)

Wright TE, Boyle KK, Duquin TR, Crane JK. Propionibacterium acnes Susceptibility and Correlation with Hemolytic Phenotype. Infect Dis (Auckl). 2016 Oct 9;9:39-44. doi: 10.4137/IDRT.S40539. eCollection 2016.

Reference Type BACKGROUND
PMID: 27773990 (View on PubMed)

Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733.

Reference Type BACKGROUND
PMID: 24306704 (View on PubMed)

Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.

Reference Type BACKGROUND
PMID: 23543526 (View on PubMed)

Mook WR, Garrigues GE. Diagnosis and Management of Periprosthetic Shoulder Infections. J Bone Joint Surg Am. 2014 Jun 4;96(11):956-965. doi: 10.2106/JBJS.M.00402. Epub 2014 Jun 4.

Reference Type BACKGROUND
PMID: 24897745 (View on PubMed)

Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.

Reference Type BACKGROUND
PMID: 15912075 (View on PubMed)

Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.

Reference Type BACKGROUND
PMID: 21543562 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HS-17-00319

Identifier Type: -

Identifier Source: org_study_id

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