drugset / Trial / NCT00515151

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

NCT00515151

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2002-05
Primary completion
Completion
2005-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator 1-propanol Unknown 30 % Topical
Comparator 2-propanol Unknown 10 % Topical
Comparator 2-propanol Unknown 45 % Topical
Comparator Alcohol Other / unclassified 74 % Topical
Comparator Octenidine Small molecule 0.1 % Topical