Antimicrobial Strategy for Device Implantation

NCT ID: NCT07158502

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

Brief Summary

Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-related endocarditis, subcutaneous pocket infections, and sepsis-are characterized by high rates of morbidity, mortality, and healthcare costs. According to current epidemiological data, the incidence of CIED-related infections is estimated to be around 0.5-2% within the first 12 months and may rise to 5% over long-term follow-up. These infections are associated with a mortality rate of up to 34% and often require device explantation and prolonged antibiotic therapy.

TauroPace™ is an antimicrobial solution based on taurolidine, a broad-spectrum, non-antibiotic agent that acts by disrupting bacterial biofilms and preventing microbial colonization. Taurolidine has a favorable safety profile, does not induce antibiotic resistance, and is already approved in Europe as a CE-marked medical device (Directive 93/42/EEC). The application of TauroPace™ to the surface of CIEDs prior to implantation may significantly reduce the incidence of infections compared to the current standard, which consists of irrigating the device pocket with sterile saline solution.

The aim of this study is to rigorously and systematically evaluate the effectiveness of TauroPace™ compared to standard clinical practice.

Conditions

CIED-related Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TauroPace Cohort

TauroPace Cohort

Intervention Type: DRUG

After sterile opening of the vial, the entire content of TauroPace™ will be poured into single-use sterile trays. Following skin incision, the surgical site will be irrigated with 5 mL of TauroPace™ solution.

The leads, device generator, and fixation sutures will then be thoroughly wiped using sterile gauze soaked in the solution. Once the leads are connected to the generator, the entire system will be treated again with TauroPace™ before being inserted into the pocket.

At the end of the procedure, the final surgical site will be irrigated once more with an additional 5 mL of TauroPace™ using a sterile syringe. A full 100 mL vial of the solution will be used for each patient, ensuring continuous antimicrobial coverage throughout the procedure.

Excess solution will be gently removed prior to surgical wound closure.

Interventions

TauroPace Cohort

After sterile opening of the vial, the entire content of TauroPace™ will be poured into single-use sterile trays. Following skin incision, the surgical site will be irrigated with 5 mL of TauroPace™ solution.

The leads, device generator, and fixation sutures will then be thoroughly wiped using sterile gauze soaked in the solution. Once the leads are connected to the generator, the entire system will be treated again with TauroPace™ before being inserted into the pocket.

At the end of the procedure, the final surgical site will be irrigated once more with an additional 5 mL of TauroPace™ using a sterile syringe. A full 100 mL vial of the solution will be used for each patient, ensuring continuous antimicrobial coverage throughout the procedure.

Excess solution will be gently removed prior to surgical wound closure.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Clinical indication for CIED implantation or generator replacement
• Signed informed consent to participate in the study

Exclusion Criteria

• Known allergy to taurolidine or any of the excipients
• Severe immunodeficiency status (e.g., patients undergoing chemotherapy, with AIDS, or immunosuppressed following organ transplantation)
• Life expectancy < 12 months due to severe comorbidities (e.g., metastatic cancer, end-stage organ failure)
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calabria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Curcio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Antonio Curcio

Role: CONTACT

antonio.curcio.cardio@unical.it

+390984681889

Other Identifiers

195/2025

Identifier Type: -

Identifier Source: org_study_id