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

Active, not recruiting

• Conditions: Osteosynthesis; Infection Prevention

• Registration Number: NCT06919770
• Lead Sponsor: University of Kiel

Brief 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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• requires osteosynthesis with placement of prosthetic materials

Exclusion Criteria

• minor, can't or won't sign PIC, can't undergo surgical procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infection	3 months	infection of osteosynthesis materials within 3 months after index procedure

Secondary Outcome Measures

Name	Time	Method
AE all grades, infections and all cause mortality during total follow up	36 months	AE all grades, infections and all cause mortality during total follow up

Trial Locations

Locations (1)

Helios Cuxhaven; 🇩🇪 Cuxhaven, Germany