Actively Recruiting
Association Between Serum Testosterone Levels and Cutibacterium Culture Positivity During Shoulder Arthroplasty
Led by University of Washington · Updated on 2025-03-30
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients undergoing shoulder arthroplasty to understand the relationship between testosterone levels and the presence of Cutibacterium bacteria on the skin and in surgical wounds. The study has two phases: Phase 1 focuses on measuring testosterone and bacterial levels before and during surgery, while Phase 2 aims to see if preoperative testosterone levels predict the risk of shoulder periprosthetic joint infection (PJI) and bacterial load during revision surgeries. In Phase 1, 51 patients having elective shoulder arthroplasty give blood samples for serum testosterone, free testosterone, and sex hormone binding globulin tests. Skin swabs are taken at the clinic pre-surgery, immediately before surgery, and from the incision during surgery, and all cultures are observed for 21 days. Phase 2 involves additional blood testing for testosterone before surgery and collects various culture samples during surgery to analyze their relationship with testosterone levels and infection risk. Participants provide demographic and health information and may respond to questions about testosterone supplements. Researchers monitor bacterial cultures from skin and tissue samples alongside blood hormone levels. The study tracks outcomes such as serum testosterone and bacterial culture results up to 20 years after surgery, including deep tissue culture bacterial loads after revision surgeries. Some participants may also join long-term follow-up studies with additional self-reported outcomes.
CONDITIONS
Brief Title
Testosterone Levels and Cutibacterium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients having elective shoulder arthroplasty
- Age between 18 and 89 years
- Fluent in English
You will not qualify if you...
- History of shoulder septic arthritis
- Antibiotic use within 3 months prior to surgery
- Recent treatment for acne
- Lack of fluency in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 pre-operative clinic visit (in-person)
Duration - Up to 30 days before surgery
Participants provide skin and blood samples during routine pre-operative visits to measure testosterone levels and bacterial cultures from the intended surgical area.
1 pre-operative clinic visit (in-person)
Duration - Day of surgery
Participants undergo shoulder arthroplasty surgery during which additional skin and incision swabs are collected for bacterial culture.
1 surgical visit (in-person)
Duration - Up to 20 years
Participants may be followed for up to 20 years after surgery to assess the association between testosterone levels and infection risk, including possible inclusion in a long-term follow-up study.
Follow-up visits as part of routine care or separate studies
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
J
Jason E Hsu, MD
A
Anastasia Whitson, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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