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Completed

NCT Number: NCT04021524

BPO vs Hibiclens 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).

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Key information

Conditions

Propionibacterium Acnes

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benzoyl Peroxide 10% Bar

Drug

Patients will wash with Benzoyl Peroxide 10% Bar

Chlorhexidine gluconate

Drug

Patients will wash with Chlorhexidine Gluconate

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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