Actively Recruiting
Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Led by Henry Ford Health System · Updated on 2025-06-04
150
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
H
Henry Ford Health System
Lead Sponsor
N
Next Science TM
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated and scheduled for primary shoulder arthroplasty
- Diagnosis of chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, or rotator cuff arthropathy
- Ability to read and understand English
- Age 18 years or older
- Failure of at least 6 weeks of conservative treatment including non-steroidal anti-inflammatory drugs (NSAIDs)
You will not qualify if you...
- History of prior native shoulder septic arthritis or infection
- Prior surgery of the 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
C
Chimdindu Obinero, BS
CONTACT
J
Jared Mahylis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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