Topical Treatment and Prevalence of P. Acnes
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clindamycin 1% Gel
Benzoyl peroxide 5% gel
BenzaClin 5%-1% Topical Gel
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Propionibacterium Acnes, Surgical Site Infection, Shoulder
Eligibility 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)
Sites / Locations
- Keck School of Medicine of the University of Southern California
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
Clindamycin alone
Benzoyl peroxide alone
Clindamycin and benzoyl peroxide
Arm Description
No topical treatment
topical clindamycin alone using Clindamycin 1% Gel
topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03257202
First Posted
August 1, 2017
Last Updated
October 25, 2019
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT03257202
Brief Title
Topical Treatment and Prevalence of P. Acnes
Official Title
Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Propionibacterium Acnes, Surgical Site Infection, Shoulder
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Healthy volunteers
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No topical treatment
Arm Title
Clindamycin alone
Arm Type
Experimental
Arm Description
topical clindamycin alone using Clindamycin 1% Gel
Arm Title
Benzoyl peroxide alone
Arm Type
Experimental
Arm Description
topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
Arm Title
Clindamycin and benzoyl peroxide
Arm Type
Experimental
Arm Description
Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel
Intervention Type
Drug
Intervention Name(s)
Clindamycin 1% Gel
Intervention Description
topical clindamycin
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide 5% gel
Intervention Description
topical benzoyl peroxide
Intervention Type
Drug
Intervention Name(s)
BenzaClin 5%-1% Topical Gel
Intervention Description
Topical clindamycin and benzoyl peroxide together
Primary Outcome Measure Information:
Title
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
Description
Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George R Hatch, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck School of Medicine of the University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23543526
Citation
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.
Results Reference
background
PubMed Identifier
24897745
Citation
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.
Results Reference
background
PubMed Identifier
24306704
Citation
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.
Results Reference
background
PubMed Identifier
25187583
Citation
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.
Results Reference
background
PubMed Identifier
19651954
Citation
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.
Results Reference
background
PubMed Identifier
27773990
Citation
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.
Results Reference
background
PubMed Identifier
15912075
Citation
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.
Results Reference
background
PubMed Identifier
21543562
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://istar.usc.edu
Available IPD/Information Identifier
HS-17-00319
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://istar.usc.edu
Available IPD/Information Identifier
HS-17-00319
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Topical Treatment and Prevalence of P. Acnes
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