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Reducing Bacteria in Shoulder Replacement Surgery

This study is looking at a way to reduce bacteria called Cutibacterium Acnes (C. acnes) during total shoulder replacement surgery. C. acnes can sometimes cause infections after surgery. Researchers want to see if applying Prontosan Wound Gel to the skin after the first cut is made helps reduce the amount of C. acnes compared to not using the gel. They will measure the number of positive cultures (samples showing bacteria growth) 14 days after surgery. This study is for adult men aged 18 or older who are having elective primary total shoulder replacement surgery. The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is a randomized controlled trial involving 60 male patients. Participants will be randomly assigned to either receive Prontosan Wound Gel or no special preparation to the skin after the incision.
What's involved
You would undergo a primary total shoulder replacement surgery. Tissue cultures will be taken after the surgery and before the wound is closed.
Compensation
Not stated in the trial record.
Follow-up
Cultures will be monitored for 14 days after surgery to check for bacterial growth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07406893

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

Recruiting
NAAges 18+InterventionalPrevention
St. Louis University
~60 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:Prontosan Wound Gel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of positive cultures
Measured over 14 days

Conditions

Joint Arthroplasty
Shoulder
Cutibacterium Acnes
Prosthetic Joint Infection

Explore related trials

Arthroplasty of shoulder

NCT07406893

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Saint Louis University

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Randall Otto, MD · PRINCIPAL_INVESTIGATOR · St. Louis University

Who to contact

Randall Otto, MD
[email protected]
314-617-2970
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of positive cultures14 days

    Each participant will have culture swabs taken at the end of the surgical case from deep, superficial, and implant locations. Cultures will be held in the lab for 2 weeks to evaluate for the presence of bacteria.