BPO vs Hibiclens Soap for Surgical Preparation

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT04021524
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Sep 10, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: Apr 16, 2021

Arms and Interventions

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

Outcome Measures

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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98105

Sponsors and Collaborators

• University of Washington

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2020
• Informed Consent Form - Aug 7, 2018

More Information

Publications

None provided.

• 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: Jul 16, 2019
• Last Update Posted: Mar 15, 2022
• Last Verified: Dec 1, 2021

• 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: Chlorhexidine; Chlorhexidine gluconate; Benzoyl Peroxide

Study Results

Participant Flow

Arm/Group Title	Hibiclens Soap	BPO Soap
Arm/Group Description	Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate	Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	24
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Hibiclens Soap	BPO Soap	Total
Arm/Group Description	Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate	Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar	Total of all reporting groups
Overall Participants	25	24	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (11.1)	63.4 (11.1)	64.4 (11.0)
Sex/Gender, Customized (Count of Participants)
Male	25 100%	24 100%	49 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	25 100%	22 91.7%	47 95.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 8.3%	2 4.1%
Body Mass Index (kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg/m^2]	28.8 (6.1)	30.3 (5.9)	29.5 (6.0)
Prior Shoulder Surgery (Count of Participants)
Count of Participants [Participants]	16 64%	4 16.7%	20 40.8%
ASA Classification (Count of Participants)
I	5 20%	0 0%	5 10.2%
II	14 56%	17 70.8%	31 63.3%
III	6 24%	7 29.2%	13 26.5%
IV	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hibiclens Soap	BPO Soap
Arm/Group Description	Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate	Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Measure Participants	25	24
Skin Surface Positive Swab	25 100%	24 100%
Dermal Edge Positive Swab	14 56%	11 45.8%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hibiclens Soap	BPO Soap
Arm/Group Description	Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate	Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Measure Participants	25	24
Skin Surface SpCuV	1.6 (1.1)	1.5 (1.4)
Dermal Edge SpCuV	0.8 (1.0)	0.8 (1.4)

Adverse Events

Time Frame	Day of surgery
Adverse Event Reporting Description	Cultures were taken on the day of surgery and held for 21 days. Adverse events were assessed after the culture results were finalized.
Arm/Group Title	Hibiclens Soap		BPO Soap
Arm/Group Description	Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate		Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
All Cause Mortality
	Hibiclens Soap		BPO Soap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Serious Adverse Events
	Hibiclens Soap		BPO Soap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Hibiclens Soap		BPO Soap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.