Examining testosterone levels and skin bacteria in shoulder surgery patients
Association Between Serum Testosterone Levels and Cutibacterium Culture Positivity During Shoulder Arthroplasty
This study is trying to see if testosterone levels in patients having shoulder surgery are linked to certain bacteria on their skin and if this affects their risk of infection after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05030220 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between serum testosterone levels and the presence of Cutibacterium bacteria in patients undergoing shoulder arthroplasty. In the first phase, blood samples and skin swabs are collected from 51 patients before and during surgery to analyze testosterone levels and bacterial load. The second phase aims to assess whether preoperative testosterone levels correlate with the risk of periprosthetic joint infection and bacterial load in deep tissue cultures during revision surgeries. The study seeks to enhance understanding of how testosterone may influence surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective shoulder arthroplasty who meet the inclusion criteria.
Not a fit: Patients with a history of shoulder septic arthritis or recent antibiotic use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify risk factors for infections in shoulder arthroplasty patients, potentially leading to improved surgical outcomes.
How similar studies have performed: While the specific correlation between testosterone levels and Cutibacterium in shoulder surgeries is novel, similar studies have explored testosterone's role in infection risk in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Phase 1 Inclusion Criteria: * Patients having elective shoulder arthroplasty Phase 1 Exclusion Criteria: * history of shoulder septic arthritis * antibiotic use within 3 months prior to surgery * recent treatment for acne * Lacked fluency in English Phase 2 Inclusion Criteria: * Patients having elective shoulder arthroplasty Phase 2 Exclusion Criteria: * Lacked fluency in English
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jason E Hsu, MD — University of Washington
- Study coordinator: Jason E Hsu, MD
- Email: jehsu@uw.edu
- Phone: 330-883-8829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.