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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Prontosan Wound Gel
DeviceApplied to dermal layer of skin after incision is made for surgery.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: No skin incision preparationNo intervention 0 interventions
Group B: Prontosan Wound GelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of positive cultures
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.
Time frame
14 daysSponsors and contacts
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St. Louis University
Lead sponsor
Innovice, LLC
Collaborator
American Shoulder and Elbow Surgeons
Collaborator
Source ClinicalTrials.gov