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OpenTrials
Active, Not Recruiting

NCT Number: NCT06919770

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helios Cuxhaven

Cuxhaven, Germany

About this study

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:

  • Infection necessitating revision procedure,
  • A requirement for prolonged antibiotic therapy, or
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • requires osteosynthesis with placement of prosthetic materials

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Infection

    Time frame: 3 months

    infection of osteosynthesis materials within 3 months after index procedure

Secondary outcomes

  1. AE all grades, infections and all cause mortality during total follow up

    Time frame: 36 months

    AE all grades, infections and all cause mortality during total follow up

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Registry information

Acronym: Prosafeti

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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