Topical Treatment and Prevalence of P. Acnes

NCT03257202 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HS-17-00319
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Propionibacterium Acnes; Surgical Site Infection; Shoulder

Outcome Measures

Primary Outcomes (1)

• 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.

  21 days

Study Arms (4)

Control

NO INTERVENTION

No topical treatment

Clindamycin alone

EXPERIMENTAL

topical clindamycin alone using Clindamycin 1% Gel

Drug: Clindamycin 1% Gel

Benzoyl peroxide alone

EXPERIMENTAL

topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

Drug: Benzoyl peroxide 5% gel

Clindamycin and benzoyl peroxide

EXPERIMENTAL

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

Drug: BenzaClin 5%-1% Topical Gel

Interventions

Clindamycin 1% Gel DRUG

topical clindamycin

Clindamycin alone

Benzoyl peroxide 5% gel DRUG

topical benzoyl peroxide

Benzoyl peroxide alone

BenzaClin 5%-1% Topical Gel DRUG

Topical clindamycin and benzoyl peroxide together

Clindamycin and benzoyl peroxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteer
• age \> 18

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (8)

• 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.

  PMID: 23543526 BACKGROUND

• 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.

  PMID: 24897745 BACKGROUND

• 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.

  PMID: 24306704 BACKGROUND

• 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.

  PMID: 25187583 BACKGROUND

• 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.

  PMID: 19651954 BACKGROUND

• 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.

  PMID: 27773990 BACKGROUND

• 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.

  PMID: 15912075 BACKGROUND

• 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.

  PMID: 21543562 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Clindamycin; Gels; Benzoyl Peroxide; clindamycin phosphate benzoyl peroxide combination

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. George Hatch
• Organization: Keck Medical Center of USC

ghatch.md@gmail.com

323-442-5860

Study Officials

• George R Hatch, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Healthy volunteers

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 22, 2017
• Study Start: September 11, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)