Study Comparing Prontosan Antimicrobial Gel Versus No Preparation on Skin During Male Shoulder Replacement Surgery to Reduce Bacterial Growth

What this Trial Is About

This research aims to compare the growth of Cutibacterium Acnes bacteria in tissue samples taken during primary shoulder replacement surgery. The study focuses on male patients undergoing elective anatomic or reverse total shoulder arthroplasty for conditions like massive rotator cuff tears, rotator cuff arthropathy, osteoarthritis, or acute fractures. Researchers want to see if applying an antimicrobial gel after the skin incision reduces bacterial presence compared to no additional skin preparation after incision. The study will enroll 60 male participants who will be randomly assigned to one of two groups one group will receive standard pre-operative antibiotics and skin preparation but no further skin treatment after incision, while the other group will have Prontosan Wound Gel applied to the dermal layer after the incision is made. Both groups will have the same antibiotic and irrigation protocols. During surgery, after the final implant is placed and before closing the wound, multiple tissue cultures will be taken to check for bacterial growth. Participants will be monitored by collecting two deep tissue cultures, two superficial tissue cultures, and one implant culture during surgery. These samples will be analyzed in the lab for up to two weeks to detect bacterial growth. The main outcome measured is the number of positive bacterial cultures after 14 days. The study will take place starting in February 2026 with follow-up focused on infection monitoring during and after surgery.

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty