CClinicalTrials.gg
Active, not recruitingNCT06919770ProsafetiUpdated Jan 20, 2026

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

An observational study in Osteosynthesis and Infection Prevention, sponsored by University of Kiel. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by University of Kiel · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Osteosynthesis
  • Infection Prevention
03

In context

Lead sponsor

University of Kiel is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

trimalleolar farcture lower extremity, requiring osteosynthesis and external fixation undergoing revision to internal fixation; osteosynthesis of upper extremity undergoing revision to receive inverse shoulder prosthesis

Inclusion criteria

  • requires osteosynthesis with placement of prosthetic materials

Exclusion criteria

Exclusion Criteria:

  • minor, can't or won't sign PIC, can't undergo surgical procedure
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
28 participants (actual)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Infection

    infection of osteosynthesis materials within 3 months after index procedure

    Time frame: 3 months

Secondary outcomes

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

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

    Time frame: 36 months

07

Study locations

1 site
  • Helios Cuxhaven
    Cuxhaven, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919770
Lead sponsor
University of Kiel
Responsible party
Prof. Dr. Hendrik Bonnemeier (coordinating Principal investigator, University of Kiel) — Principal investigator
First posted
Apr 9, 2025
Start date
Jan 1, 2022
Primary completion
Jul 30, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jan 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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