Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Not Applicable

Recruiting

• Conditions: Arthroplasty Shoulder; Periprosthetic Joint Infection
• Interventions: Drug: Chlorhexidine Gluconate

• Registration Number: NCT06464770
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Study Start: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Randomization Option 1	Chlorhexidine Gluconate	Right shoulder, Test Group ; Left shoulder, Control Group
Randomization Option 2	Chlorhexidine Gluconate	Right shoulder, Control Group ; Left shoulder, Test Group

Primary Outcome Measures

Name	Time	Method
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure	60 Minutes After ChloraPrep Wash
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure	60 Minutes After ChloraPrep Wash

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States