Optimizing Infection Prophylaxis Prior to Shoulder Surgery

University of Washington

Status: Enrolling

Conditions: Periprosthetic Joint Infection; Arthroplasty Shoulder

Treatments: Drug: Chlorhexidine Gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT06464770

STUDY00020250

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Randomization Option 1

Experimental group

Description:

Right shoulder, Test Group ; Left shoulder, Control Group

Treatment:

Drug: Chlorhexidine Gluconate

Randomization Option 2

Experimental group

Description:

Right shoulder, Control Group ; Left shoulder, Test Group

Treatment:

Drug: Chlorhexidine Gluconate