Topical Treatment and Prevalence of P. Acnes

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT03257202
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 3.3

Study Details

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.

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

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Healthy volunteersHealthy volunteers
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide
• Actual Study Start Date: Sep 11, 2017
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms [21 days]

   Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck School of Medicine of the University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: George R Hatch, MD, University of Southern California

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 2, 2017

More Information

Publications

• 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.
• 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. Review. Update in: Cochrane Database Syst Rev. 2015;(4):CD003949.
• 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.
• 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.
• 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.
• Mook WR, Garrigues GE. Diagnosis and Management of Periprosthetic Shoulder Infections. J Bone Joint Surg Am. 2014 Jun 4;96(11):956-965. Epub 2014 Jun 4. Review.
• 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.
• 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. eCollection 2016.

• Responsible Party: George F. Hatch, Principal Investigator, University of Southern California
• ClinicalTrials.gov Identifier: NCT03257202
• Other Study ID Numbers: HS-17-00319
• First Posted: Aug 22, 2017
• Last Update Posted: Nov 13, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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. Hatch, Principal Investigator, University of Southern California: Propionibacterium Acnes; Surgical Site Infection; Shoulder
• Additional relevant MeSH terms: Surgical Wound Infection; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide

Study Results

Participant Flow

Pre-assignment Detail	All 12 patients received each of the 4 study arms.

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Negative Control Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel Topical clindamycin alone using Clindamycin 1% Gel BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	29.4
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	10 83.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Negative Control	Benzoyl Peroxide 5% Topical Gel	Clindamycin 1% Topical Gel	Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel
Arm/Group Description	The participants did not receive treatment in this quadrant.	This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel	This quadrant of the participants' back received Clindamycin 1% topical gel	This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel
Measure Participants	12	12	12	12
Number [participants]	10 83.3%	12 NaN	10 NaN	10 NaN

Adverse Events

Time Frame	24 days
Arm/Group Title	Control		Clindamycin Alone		Benzoyl Peroxide Alone		Clindamycin and Benzoyl Peroxide
Arm/Group Description	No topical treatment		topical clindamycin alone using Clindamycin 1% Gel Clindamycin 1% Gel: topical clindamycin		topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel Benzoyl peroxide 5% gel: topical benzoyl peroxide		Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together
All Cause Mortality
	Control		Clindamycin Alone		Benzoyl Peroxide Alone		Clindamycin and Benzoyl Peroxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Control		Clindamycin Alone		Benzoyl Peroxide Alone		Clindamycin and Benzoyl Peroxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Control		Clindamycin Alone		Benzoyl Peroxide Alone		Clindamycin and Benzoyl Peroxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.