Cutibacterium Acnes, Dihydrotestosterone, Periprosthetic Joint Infection (PJI)
Conditions
Keywords
placebo, blood draw, skin culture
Brief summary
High levels of Testosterone causes high amounts of skin bacteria (Cutibacterium Acnes) which can go into the skin during a shoulder replacement surgery and cause a terrible infection. The goal of this experiment is to have participants take Finasteride, a medication that blocks testosterone production, for 2 weeks and evaluate the following: * Blood levels of testosterone * Amount of bacteria on the skin. Participants will: * Be assigned to take Finasteride, or a placebo (a look-alike pill with no active medicine) once daily, for 2 weeks * Have a small sample of their blood collected and their skin swabbed with a Q-tip to determine Testosterone levels and bacteria on the skin * Blood draw and skin testing will take place before starting Finasteride or the placebo (day 0) and at the end of the experiment (day 14).
Interventions
DRUGFinasteride 1 mg
Patients randomized to the experimental group will receive oral Finasteride 1 mg, taken daily, for two weeks
DRUGPlacebo Control
Patients randomized to the placebo group will receive one pill containing no active medicine, taken daily, for two weeks.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion We will include the group most impacted by PJI * Adult males * Age between 18 and 65 Exclusion * History of cryptorchidism, hypospadias, or other congenital abnormality of male reproductive tract * Female sex * Age younger than 18 or older than 65 * Current use of Finasteride or other 5-alpha reductase inhibitors * Current use of hormone replacement medications such as testosterone * Recent antibiotic use within 3 months * Have had a negative reaction to oral Finasteride before * Recent use of acne treatment within 3 months * Self-report very sensitive skin * Allergic to chlorhexidine or isopropyl alcohol * Have open wounds on both shoulders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cutibacterium skin load | Skin load will be assessed at day 0 and at the end of the study on day 14 of treatment or placebo. | Skin load will be determined using bacterial culture of the skin and assigning a value based on the report from the microbiology lab: 0 for "no growth"; 0.1 for "growth of 1 colony only" or for "growth in broth only"; and 1, 2, 3 and 4 for 1+, 2+, 3+ and 4+ growth, respectively. Mann-Whitney U test will be used to compare the change in the semi-quantitative skin load at baseline and day 14 in the intervention and control group, along with comparison of the percentage of subjects in each group that began with a high baseline skin load (\>2) and ended with a low skin load (≤1). |
| Serum Dihydrotestosterone (DHT) Level | levels will be assessed at baseline and after 14 consecutive days of treatment or placebo. | Participants blood will be collected and processed for serum DHT level by the certified and state-licensed phlebotomists and clinical laboratory technicians at our intuition, which is in the same building as the outpatient clinic. |
Contacts
CONTACTAnastasia Whitson
PRINCIPAL_INVESTIGATORCorey Schiffman, MD
University of Washington
Outcome results
None listed