RecruitingNot ApplicableNCT07406893
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients
Sponsor
St. Louis University
Enrollment
60 participants
Start Date
Feb 23, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus Prontosan wound gel applied to the skin layer after the skin incision has been made.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria1
- 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 Criteria5
- 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
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Interventions
DEVICEProntosan Wound Gel
Applied to dermal layer of skin after incision is made for surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07406893
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