NCT06919770

Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: University of Kiel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A taurolidine-based antimicrobial solution, was evaluated for its safety and efficacy in preventing infections associated with prosthetic materials, such as joint replacements, plates, nails, and screws. This prospective observational study compared Taurolidine to infection rates from scientific literature.

Detailed description

During any invasive procedure involving prosthetic materials at the corresponding author's institution, the surgical site was irrigated, and all accessible hardware (including nails, screws, plates, and prosthetic joint replacement therapy devices) was wiped with Taurolidine. Only procedures performed between 01/01/2022 and 01/10/2023, where Taurolidine was applied, were included in the analysis. Patients who underwent multiple procedures were censored for the last treatment group and reassigned at the next procedure. Preoperative antibiotic prophylaxis was administered according to institutional guidelines, and no additional intraoperative antimicrobial agents were used aside from Taurolidine. The primary endpoint was the occurrence of a major infection within three months post-procedure, defined as: 1. Infection necessitating revision procedure, 2. A requirement for prolonged antibiotic therapy, or 3. Infection leading to mortality. Secondary endpoints included infections beyond three months, adverse events potentially related to the antimicrobial solution, procedural complications (i.e., hematoma formation, nerval lesions, etc), and mortality during all follow-up.

Conditions

• Osteosynthesis
• Infection Prevention

Timeline

• Start date: 2022-01-01
• Primary completion: 2030-07-30
• Completion: 2030-12-31
• First posted: 2025-04-09
• Last updated: 2026-01-20

Locations

1 site across 1 country: Germany