Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed

Completed

• Conditions: Central Venous Catheter

• Registration Number: NCT05124821
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-18
• Study Start: 2023-05-19
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
• Patient's first catheter placement during current hospital stay
• Placement of catheter according to IFU (Instruction for Use)

Exclusion Criteria

• Contraindications according to IFU
• Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
• Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Late complications	up to 30 days	Incidence of malpositioning of catheter due to dislodgement or migration

Secondary Outcome Measures

Name	Time	Method
Early complications of central venous catheter application	Up to 2 hours
Catheter handling details	up to 30 days	Observations on catheter quality
Reason for removal of catheter	up to 30 days	Technical problems with the catheter
Incidence of systemic infection	up to 30 days
Serious Adverse Event (SAE)	up to 30 days
Serious Adverse Device Effect (SADE)	up to 30 days
Concomitant medication	up to 30 days	Use of antibiotics or other relevant medication
Adverse Device Effect (ADE)	up to 30 days
Device Deficiency (DD)	up to 30 days	Action taken
Demographic data	Prior study start	Ethnicity
Catheter variables	up to 30 days	Length

Trial Locations

Locations (3)

Medizinische Hochschule Hannover, Klinik für Pädiatrische Kardiologie und Pädiatrische Intensivmedizin; 🇩🇪 Hannover, Germany

Istituto Giannina Gaslini, Anesthesia and Acute and Procedural Pain Therapy; 🇮🇹 Genova, Italy

Ospedale de Bambini Vittore Buzzi; 🇮🇹 Milano, Italy