Reducing bacterial contamination during primary shoulder replacement
Official title: Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients
Run by St. Louis University · NCT07406893 · Data updated 2026-11-12
This trial tests whether putting Prontosan antimicrobial gel on the dermal layer after the skin is cut can lower Cutibacterium acnes growth in men having primary shoulder replacement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | St. Louis University Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07406893 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men (age 18 or older) scheduled for elective primary anatomic or reverse total shoulder arthroplasty for degenerative or cuff-related indications are ideal candidates.
✕Probably not a fit
Patients undergoing revision shoulder arthroplasty, women, those allergic to Prontosan ingredients, those unable to consent, or non-English speakers are excluded and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized controlled trial enrolling 60 adult men undergoing primary anatomic or reverse total shoulder arthroplasty. Participants are randomly assigned 1:1 to receive either Prontosan wound gel applied to the dermal layer after incision or no post-incision dermal preparation, with all patients receiving the same pre-incision skin prep, prophylactic antibiotics, and intraoperative irrigation. After final implantation and before wound closure, surgical site cultures (two deep, two superficial, and one implant) are collected and held in the lab for two weeks to monitor growth of Cutibacterium acnes. The primary outcome is the presence of C. acnes growth on intraoperative cultures.
Why it matters
Potential benefit: If successful, this approach could reduce Cutibacterium acnes contamination and lower the risk of prosthetic joint infection after shoulder replacement.
How similar studies have gone: Prior work targeting Cutibacterium acnes with perioperative skin preparations has shown mixed results, and applying an antimicrobial gel to the dermal layer after incision is a relatively novel strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult male 18 years of age or older undergoing elective primary total shoulder arthroplasty, including both anatomic and reverse total shoulder arthroplasty, for indications including massive rotator cuffs, rotator cuff arthropathy, glenohumeral osteoarthritis, and acute fractures. Exclusion Criteria: * Any revision shoulder arthroplasty procedure or other shoulder surgery that is not a primary shoulder arthroplasty. * Patients with allergy to active ingredients in Prontosan gel * Patient is unable to consent for themselves * Patient is non-English speaking * Females
Where it's running
-
Saint Louis University
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Randall Otto, MD — St. Louis University
- Study coordinator: Randall Otto, MD
- Email: randy.otto@health.slu.edu
- Phone: 314-617-2970
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.