Optimizing Infection Prophylaxis Prior to Shoulder Surgery

The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:

Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.

Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.

Study Overview

• Status: Recruiting
• Conditions: Periprosthetic Joint Infection; Arthroplasty Shoulder
• Intervention / Treatment: Drug: Chlorhexidine Gluconate

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anastasia Whitson; Phone Number: 206-755-7847; Email: whitsa@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • University of Washington
      • Contact: Anastasia Whitson, BSPH; Phone Number: 206-755-7847; Email: whitsa@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking

Exclusion Criteria:

• Self report very sensitive skin
• Allergic to chlorhexidine
• Used antibiotics in the last three months
• Used acne treatment in the last three months
• Wounds on your shoulders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomization Option 1; Right shoulder, Test Group ; Left shoulder, Control Group	Drug: Chlorhexidine Gluconate; Test Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at lower pressure (similar to a gentle wipe) for 30 seconds Control Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at higher pressure (similar to a massage) for 30 seconds
Experimental: Randomization Option 2; Right shoulder, Control Group ; Left shoulder, Test Group	Drug: Chlorhexidine Gluconate; Test Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at lower pressure (similar to a gentle wipe) for 30 seconds Control Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at higher pressure (similar to a massage) for 30 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure	60 Minutes After ChloraPrep Wash
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure	60 Minutes After ChloraPrep Wash

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Jason Hsu, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chlorhexidine; periprosthetic joint infection; shoulder arthroplasty; cutibacterium
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Dermatologic Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: STUDY00020250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No