Post-incision antimicrobial washes to reduce C. acnes after shoulder replacement
Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial
This trial will test whether applying different antimicrobial washes after the first incision lowers C. acnes growth in adults having primary shoulder replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06831422 on ClinicalTrials.gov |
What this trial studies
This randomized trial assigns adults undergoing primary shoulder arthroplasty 1:1:1:1 to one of four post-incision approaches: Xperience Antimicrobial wash, 3% hydrogen peroxide, 10% povidone-iodine, or no post-incision treatment. Cultures are collected from the surgical site before incision, the incision after the initial cut, the shoulder joint, and room air, and are monitored daily for C. acnes for up to 18 days. Patients receive routine postoperative clinical evaluations of wound healing and complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year, with data stored in a secure database and supplemented by electronic medical record review. Outcomes will compare rates of positive C. acnes cultures across the four groups to see if post-incision washes reduce contamination.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) scheduled for primary shoulder arthroplasty for degenerative conditions who have failed at least six weeks of conservative treatment and have no prior shoulder infection or prior surgery on the affected shoulder.
Not a fit: Patients with prior native shoulder septic arthritis or prior surgery on the affected shoulder, active infection, cancer, autoimmune or rheumatologic disorders, proximal humerus fracture, or allergy to citric acid–derived products are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower C. acnes contamination and potentially reduce postoperative infection and related complications after shoulder replacement.
How similar studies have performed: Povidone-iodine and hydrogen peroxide have been used to reduce bacterial contamination in orthopedic procedures, but data specifically targeting C. acnes after shoulder arthroplasty are limited and the Xperience Antimicrobial wash represents a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Detroit, Michigan
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Chimdindu Obinero, BS
- Email: cobiner1@hfhs.org
- Phone: 678-230-8592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.