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Comparison of uncoated central venous catheters with and without transient coating as product protection with regard to biofilm formation

Comparison of uncoated central venous catheters with and without transient coating as product protection with regard to biofilm formation - CutSep

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024211
Enrollment
852
Registered
2021-02-18
Start date
2021-05-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of cathetersepsis

Interventions

Group 1: Application of a new preventive measure during insertion of a central venous catheter Group 2: Control: Insertion of a central venous catheter without an additional preventive measure

Sponsors

Solvamed GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients should be included in the study, which: - be supplied with uncoated central venous catheters - have at least a catheter time of 60 hours - have been given their consent and have understood the consent form - are over 18 years old

Exclusion criteria

Exclusion criteria: Patients will not be admitted to the clinical trial if any of the following criteria are available: - Catheter lying time less than 60 hours - in front of lying the catheter, there are already positive blood culture evidence on the side of the clinic - The absence of a signed declaration of consent - Pregnant or breastfeeding women - Patients after catheter change

Design outcomes

Primary

MeasureTime frame
Reduction of the number of biofilm positive peaks by at least 25%

Secondary

MeasureTime frame
Improvement of the infectious aspects of the patient and the granting of the safety of the product

Countries

Germany

Contacts

Public ContactStefan Margraf

Solvamed GmbH

margraf@solvamed.de01726394134

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026