Clinical trial NCT03257202: Topical Treatment and Prevalence of P. Acnes
Official title: Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Site Infection
Keywords: Propionibacterium Acnes
Surgical Site Infection
Shoulder
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of the University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: George R Hatch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.