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BPO vs Hibiclens Soap for Surgical Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04021524
Recruitment Status : Active, not recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Information provided by (Responsible Party):
Frederick Matsen, University of Washington

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Propionibacterium Acnes Drug: Benzoyl Peroxide 10% Bar Drug: Chlorhexidine Gluconate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 1, 2019

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

Primary Outcome Measures :
  1. Load of Propionibacteria on Day of Surgery After At-Home Washes with Benzoyl Peroxide or Chlorhexidine Gluconate [ Time Frame: Samples taken on day of surgery, cultures held for 21 days ]
    Load of Propionibacteria on the skin and incision of patients 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04021524

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United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
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Principal Investigator: Frederick Matsen, MD University of Washington
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Responsible Party: Frederick Matsen, Professor and Chairman, School of Medicine: Orthopaedics and Sports Medicine, University of Washington Identifier: NCT04021524    
Other Study ID Numbers: STUDY00005028
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine gluconate
Benzoyl Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents