Iodine, Shoulder Surgery, Total Shoulder Arthroplasty
Conditions
Brief summary
This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery
Interventions
PROCEDURETotal shoulder arthroplasty
Participant will have total shoulder arthroplasty surgery
DRUGIodine impregnated drapes
After cleaning the shoulder area in preparation for surgery, the area will be covered and draped using iodine impregnated drapes prior to the start of the participants surgery.
PROCEDURETissue Culture Samples
One deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery.
Sponsors
tnicholson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥ 18 years * Written informed consent * Elective primary total shoulder arthroplasty * Male patients
Exclusion criteria
* Prior surgery on the operative shoulder * Iodine allergy * Participation in other clinical trials * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture positivity rate | 13 days | One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSurena Namdari, MD
Rothman Orthopaedic Institute
Outcome results
None listed