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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06919770
Acronym
Prosafeti
Enrollment
28
Registered
2025-04-09
Start date
2022-01-01
Completion date
2030-12-31
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Prevention, Osteosynthesis

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.

Interventions

None listed

Sponsors

University of Kiel
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* requires osteosynthesis with placement of prosthetic materials

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Infection3 monthsinfection of osteosynthesis materials within 3 months after index procedure

Secondary

MeasureTime frameDescription
AE all grades, infections and all cause mortality during total follow up36 monthsAE all grades, infections and all cause mortality during total follow up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026