Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Health-care-acquired infections are of tremendous importance for patients, especially catheter-associated infections. More than 40% of all bloodstream infections are associated with central venous catheters (CVC; catheters which are inserted into a large vein near the heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The insertion site is the main source of contamination and infection. In general, bacteria of the skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is necessary to efficiently disinfect the skin for the preparation and care of CVC insertion sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly used in Central Europe, other preparations contain povidine-iodine or chlorhexidine. Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving a CVC for a minimum of 5 days.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborator: University Hospital, Basel, Switzerland
• Treatments: Ethanol; Octenidine

Criteria

Inclusion Criteria:

• Patients >18 years

• 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

• 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