Prontosan Wound Gel for Shoulder Joint Replacement Surgery
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Randall Otto, MD
Principal Investigator
St. Louis University
Are You a Good Fit for This Trial?
This trial is for individuals undergoing primary shoulder replacement surgery who may be at risk of bacterial infection from Cutibacterium Acnes. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Treatment
Participants undergo shoulder arthroplasty with either Prontosan gel application or no additional dermal preparation
Culture Monitoring
Cultures are monitored in the lab for growth of C. acnes
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Prontosan Wound Gel
Trial Overview
The study is testing if applying Prontosan wound gel after making a skin incision during shoulder replacement can reduce the growth of bacteria compared to no additional treatment. It's a comparison between treated versus untreated surgical sites.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will be prepped with Prontosan Wound Gel for patients in this arm. Prontosan Wound gel is an antimicrobial gel agent intended to keep wounds free of bacteria.
All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with any additional agents for patients in this arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Louis University
Lead Sponsor
Innovice, LLC
Collaborator
American Shoulder and Elbow Surgeons
Collaborator
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