Optimizing Infection Prophylaxis Prior to Shoulder Surgery

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06464770
Status
Recruiting
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Conditions

  • Arthroplasty Shoulder
  • Periprosthetic Joint Infection

Eligibility Criteria

Sex
MALE
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Chlorhexidine Gluconate — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure [ Time Frame: 60 Minutes After ChloraPrep Wash ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98105
Anastasia Whitson, BSPH
[email protected]
206-755-7847

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By research site
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