Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSt. Louis University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prontosan Wound Gel
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
St. Louis University
Lead sponsor
Innovice, LLC
Collaborator
American Shoulder and Elbow Surgeons
Collaborator
Source ClinicalTrials.gov