Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05030220 |
Other study ID # |
STUDY00009200 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
January 1, 2027 |
Study information
Verified date |
December 2023 |
Source |
University of Washington |
Contact |
Jason E Hsu, MD |
Phone |
330-883-8829 |
Email |
jehsu[@]uw.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Phase 1: 51 patients having elective shoulder arthroplasty were offered the opportunity to
participate, consented and enrolled in this prospective clinical cohort study.
At a preoperative clinic visit, basic demographic information was collected along with the
patient's response to a question about taking supplemental testosterone. A swab of the
unprepared skin over the area of the intended surgical incision was obtained and sent for
culture. At this clinic visit, a sample of the patient's blood was also obtained and
submitted to our clinical laboratory for the levels of total serum testosterone, sec hormone
binding globulin (SHBG), and free testosterone.
Immediately before surgery, another swab of the unprepared skin over the area of the intended
surgical incision was once again obtained and sent for culture. After incision, a swab of the
freshly incised dermis was obtained and sent for culture.
All 3 swabs that were obtained were observed for 21 days. The investigators analyzed the
cultures to determine the presence and load of bacteria using a semiquantitative method,
known as the Cutibacterium specimen value (SpCuV)
Phase 2: This phase will also involve a onetime pre-operative testosterone serum test. If the
subject consents to participate, this additional sample of blood will be collected for a
testosterone serum test during the routine pre-operative blood draw that all patients have
before a shoulder arthroplasty regardless of research participation. The investigators will
include cultures such as skin swabs taken at pre-operative clinic appointments, skin swabs
taken at the time of surgery, incision swabs taken at the time of surgery, and discarded
tissue from surgery using our standard protocol for specimens. For this study's outcome
measures, the investigators will record the culture results from those clinical specimens and
compare them to the testosterone serum test. Some subjects may also be a part of a long term
follow-up study and the follow-up data (self-reported outcome measures, etc.) from that study
will be included for analysis for those patients.