Skin Disinfection with Octenidine Dihydrochloride for the Prevention of Catheter-associated Infections ? A Double-Blind, Randomised, Controlled Trial

Phase 4

• Conditions: Catheter-associated InfectionsBacteremia; A41; Other sepsis

• Registration Number: DRKS00000006
• Lead Sponsor: niversitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2005-04-20
• Study Start: 2008-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients >18 years and medical indication for CVC with a planned duration of minimum 5 days. Patient´s (or relative´s if applicable) written informed consent

Exclusion Criteria

Known sensitisation against the proposed antiseptics, tunneled or implanted CVCs (e.g. Hickman Catheter), administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization, pre-existing bloodstream infection (i.e., fever and/or other signs of infection, positive blood culture), terminal patients with limited therapy options and patients with burns, patients participating in a clinical trial on other antiseptics within a period of four weeks prior to inclusion date, patients with missing written consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin colonisation in cfu/cm2 at the insertion site, Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method),<br>Incidence of catheter-associated bloodstream infection.<br>[Time Frame: For the duration of catheter placement plus 2 days]

Secondary Outcome Measures

Name	Time	Method
Comparison of therapy regimens regarding side effects and complications. [Time Frame: For the duration of catheter placement plus 30 days]