Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Periprosthetic Joint Infection Clinical Trial

Official title:

Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464770
• Other study ID #: STUDY00020250
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: Anastasia Whitson
• Phone: 206-755-7847
• Email: whitsa[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Shoulder
• Communicable Diseases
• Infections
• Periprosthetic Joint Infection

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure		60 Minutes After ChloraPrep Wash
Primary	Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure		60 Minutes After ChloraPrep Wash