BPO vs Hibiclens Soap for Surgical Preparation

University of Washington

Status and phase: Completed; Phase 4

Conditions: Propionibacterium Acnes

Treatments: Drug: Chlorhexidine Gluconate; Drug: Benzoyl Peroxide 10% Bar

Study type: Interventional

Funder types: Other

Identifiers

NCT04021524

STUDY00005028

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Hibiclens Soap

Active Comparator group

Treatment:

Drug: Chlorhexidine Gluconate

BPO Soap

Experimental group

Treatment:

Drug: Benzoyl Peroxide 10% Bar