NCT07406893

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: St. Louis University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

60 male patients undergoing primary anatomic or reverse shoulder arthroplasty will be enrolled in this prospective, randomized controlled trial evaluating the use of Prontosan wound gel versus no preparation to the dermal layer of skin after incision has been made. Participants will be randomly assigned to one of two groups of 30 patients: control (no post-incision dermal preparation) and Prontosan antimicrobial gel application to the dermal layer after skin incision. All patients, regardless of assignment, receive the same pre-incision skin preparations, prophylactic antibiotics, and intraoperative irrigation. After final implantation and before wound closure, culture swabs will be obtained (2 deep cultures, 2 superficial, and 1 implant). All cultures will be held in the lab for 2 weeks to monitor for growth of C. acnes.

Conditions

• Joint Arthroplasty
• Shoulder
• Cutibacterium Acnes
• Prosthetic Joint Infection

Interventions

Type	Name	Description
DEVICE	Prontosan Wound Gel	Applied to dermal layer of skin after incision is made for surgery.

Timeline

• Start date: 2026-02-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-12
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study