BPO vs Hibiclens Soap for Surgical Preparation

NCT ID: NCT04021524

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2021-04-16

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).

Conditions

Propionibacterium Acnes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hibiclens Soap

Group Type: ACTIVE_COMPARATOR

Chlorhexidine Gluconate

Intervention Type: DRUG

Patients will wash with Chlorhexidine Gluconate

BPO Soap

Group Type: EXPERIMENTAL

Benzoyl Peroxide 10% Bar

Intervention Type: DRUG

Patients will wash with Benzoyl Peroxide 10% Bar

Interventions

Benzoyl Peroxide 10% Bar

Patients will wash with Benzoyl Peroxide 10% Bar

Intervention Type: DRUG

Chlorhexidine Gluconate

Patients will wash with Chlorhexidine Gluconate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Frederick Matsen

Professor and Chairman, School of Medicine: Orthopaedics and Sports Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederick Matsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00005028

Identifier Type: -

Identifier Source: org_study_id