Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Recruiting now · Not applicable
Conditions studied: Shoulder Arthroplasty, Positive C. Acnes Culture
In brief
The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments: * Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL) * Post-incision application of 3% hydrogen peroxide * Post-incision application of 10% povidone-iodine (betadine) * No post-incision treatment (control) The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
Key facts
- Study ID
- NCT06831422
- Run by
- Henry Ford Health System
- People needed
- 150
- Starts
- 2025-05-05
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Indicated and scheduled for primary shoulder arthroplasty.
- Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
- Ability to read and understand English
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)
You may not qualify if…
- Patient with history of prior native shoulder septic arthritis or infection
- Prior surgery of affected shoulder
- Proximal Humerus Fracture
- Active infection
- Cancer
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
- History of allergic reaction to citric acid-derived products
Where it is running
- Henry Ford Health — Detroit, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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