At a glance
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Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial
In Brief
A Phase 4 clinical trial evaluating 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol and 74% Ethanol with 10% 2-propanol for Catheterization, Central Venous and 3 related conditions. Completed, enrolled 400 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of \>200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of \>200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.