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Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06464770
Enrollment
40
Registered
2024-06-18
Start date
2024-08-31
Completion date
2027-12-31
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Shoulder, Periprosthetic Joint Infection

Keywords

periprosthetic joint infection, cutibacterium, shoulder arthroplasty, chlorhexidine

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.

Interventions

DRUGChlorhexidine 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

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomization Option 1: Right shoulder, Test Group ; Left shoulder, Control Group Randomization Option 2: Right shoulder, Control Group ; Left shoulder, Test Group

Eligibility

Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure60 Minutes After ChloraPrep Wash
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure60 Minutes After ChloraPrep Wash

Countries

United States

Contacts

Primary ContactAnastasia Whitson
whitsa@uw.edu206-755-7847

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026