Reducing bacterial contamination during primary shoulder replacement
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients
NA · St. Louis University · NCT07406893
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | St. Louis University (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07406893 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
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.
Conditions: Joint Arthroplasty, Shoulder, Cutibacterium Acnes, Prosthetic Joint Infection, Antimicrobial wound gel, Dermal layer, Skin preparation