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BPO vs Hibiclens Soap for Surgical Preparation

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ClinicalTrials.gov Identifier: NCT04021524
Recruitment Status : Completed
First Posted : July 16, 2019
Results First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Sponsor:
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
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : April 16, 2021


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. Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate [ Time Frame: Day of Surgery ]
    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.

  2. Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate [ Time Frame: Day of Surgery ]
    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.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04021524


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Frederick Matsen, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Frederick Matsen, University of Washington:
Informed Consent Form  [PDF] August 7, 2018

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Responsible Party: Frederick Matsen, Professor and Chairman, School of Medicine: Orthopaedics and Sports Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04021524    
Other Study ID Numbers: STUDY00005028
First Posted: July 16, 2019    Key Record Dates
Results First Posted: March 15, 2022
Last Update Posted: March 15, 2022
Last Verified: December 2021

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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
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Benzoyl Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents