BPO vs Hibiclens Soap for Surgical Preparation

Propionibacterium Acnes Clinical Trial

Official title:

Randomized Trial of Hibiclens vs Benzoyl Peroxide Soap for Surgical Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021524
• Other study ID #: STUDY00005028
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2018
• Est. completion date: April 16, 2021

Study information

• Verified date: December 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 16, 2021
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Propionibacterium Acnes

Intervention

Drug:
• Benzoyl Peroxide 10% Bar
Patients will wash with Benzoyl Peroxide 10% Bar
• Chlorhexidine Gluconate
Patients will wash with Chlorhexidine Gluconate

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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