Recruiting

Testosterone & Cutibacterium

Sponsor:

University of Washington

Code:

NCT05030220

Conditions

Arthroplasty, Replacement, Shoulder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Phase 1: In 51 patients undergoing shoulder arthroplasties, total serum testosterone, free testosterone and sex hormone binding globulin levels obtained in the clinic before surgery were correlated with the levels of Cutibacterium on the skin in clinic, in the operating room prior to surgery, and in the skin incision.

Phase 2: The investigators wish to determine if preoperative serum testosterone levels are associated with risk for shoulder PJI (periprosthetic joint infection) in patients undergoing primary shoulder arthroplasty. Also to determine if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.

Conditions

Arthroplasty, Replacement, Shoulder

Study ID

NCT05030220

Start date

Jul 1, 2020

Status verified date

Mar, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Phase 1

51 subjects with serum levels of testosterone, free testosterone, and sex hormone binding globulin as well as the SpCuV from the cultures obtained in clinic, immediately pre-operative skin cultures, and incised wound cultures.

Phase 2

Subjects enrolled to help determine if preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty and if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.

Primary outcome measure

  • Serum testosterone [ Time Frame: At pre-operative clinic appointment, typically within 30 days prior to surgery ]
  • Free testosterone [ Time Frame: At pre-operative clinic appointment, typically within 30 days prior to surgery ]
  • sex hormone binding globulin [ Time Frame: At pre-operative clinic appointment, typically within 30 days prior to surgery ]
  • Cutibacterium specimen value [ Time Frame: Skin swab at pre-operative clinic appointment, typically within 30 days prior to surgery ]
  • Cutibacterium specimen value [ Time Frame: Skin swab immediately pre-operative ]
  • Cutibacterium specimen value [ Time Frame: Freshly incised dermis of surgical wound ]
  • Preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty. [ Time Frame: Up to 20 years after surgery ]
  • Preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty [ Time Frame: 21 days after surgery ]

Central Contacts and Locations

Central contacts

Jason E Hsu, MD

330-883-8829jehsu@uw.edu

Anastasia Whitson, BS

206-755-7847whitsa@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Jason Hsu, MD

jehsu@uw.edu

Anastasia Whitson, BS

whitsa@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • Testosterone
  • Cutibacterium
  • Shoulder Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-03-30.