BPO vs Hibiclens Soap for Surgical Preparation

Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation

This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).

Study Overview

• Status: Completed
• Conditions: Propionibacterium Acnes
• Intervention / Treatment: Drug: Chlorhexidine Gluconate; Drug: Benzoyl Peroxide 10% Bar

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male subjects
• Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
• Subjects between ages 18-89

Exclusion Criteria:

• Subjects who self-report very sensitive skin
• Subjects who are sensitive to benzoyl peroxide
• Subjects who are allergic to chlorhexidine
• Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
• Subjects who had recent use of acne treatment
• Subjects who are not fluent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hibiclens Soap	Drug: Chlorhexidine Gluconate; Patients will wash with Chlorhexidine Gluconate
EXPERIMENTAL: BPO Soap	Drug: Benzoyl Peroxide 10% Bar; Patients will wash with Benzoyl Peroxide 10% Bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate	Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days.	Day of Surgery
Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate	This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: "no growth"= 0, "broth only"= 0.1, "one colony only"= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days.	Day of Surgery

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Frederick Matsen, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): April 16, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Benzoyl Peroxide; Chlorhexidine gluconate
• Other Study ID Numbers: STUDY00005028

Drug and device information, study documents

• 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.: No