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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06216080
Other study ID # OCT-BIO-CVC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date March 31, 2024

Study information

Verified date January 2024
Source Centre Hospitalier William Morey - Chalon sur Saône
Contact Thomas Maldiney
Phone +33385910474
Email thomas.maldiney@ch-chalon71.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality. It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias. We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient or relative informed of the study and having declared their nonobjection - Patient over 18 years of age - Patient exposed to central venous catheter for at least two calendar days Exclusion Criteria: - Patient unable to declare their nonobjection - Patient whose central venous catheter collection is impossible - Patient admitted in ICU with a central venous catheter already in place

Study Design


Intervention

Other:
D-FF-OCT analysis of CVC
Dynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm

Locations

Country Name City State
France William Morey General Hospital (Chalon-sur-Saône) Chalon sur Saône Saône-et-Loire

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier William Morey - Chalon sur Saône Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

References & Publications (2)

Perez-Granda MJ, Guembe M, Cruces R, Barrio JM, Bouza E. Assessment of central venous catheter colonization using surveillance culture of withdrawn connectors and insertion site skin. Crit Care. 2016 Feb 2;20:32. doi: 10.1186/s13054-016-1201-0. — View Citation

Silva Paes Leme AF, Ferreira AS, Alves FA, de Azevedo BM, de Bretas LP, Farias RE, Oliveira MG, Raposo NR. An effective and biocompatible antibiofilm coating for central venous catheter. Can J Microbiol. 2015 May;61(5):357-65. doi: 10.1139/cjm-2014-0783. Epub 2015 Mar 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary D-FF-OCT-based biofilm structure type Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT At Day 0, within 24h following catheter removal
Secondary D-FF-OCT-based biofilm thickness Biofilm thickness, measured with D-FF-OCT At Day 0, within 24h following catheter removal
Secondary D-FF-OCT-based dynamic signal distribution Biofilm dynamic signal distribution, measured with D-FF-OCT At Day 0, within 24h following catheter removal
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