Clinical trial NCT00515151: Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride
Official title: Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheterization, Central Venous
Catheter-Associated Infections
Bacterial Infections
Bacteremia
Keywords: Bloodstream Infection
Bacteremia
Central Venous Catheter
Alcohol
Disinfection
Octenidine Dihydrochloride
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2007-08-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Catheter-associated infections are one of the most eminent healthcare acquired infections. More than 40% of all bloodstream infections are associated with a central venous catheter (CVC)and between 1% and 5% of the affected patients die as a direct consequence of this infection. The most important microorganisms are gram-positive cocci (S. aureus, S. epidermidis). In intensive care units gram-negative microorganisms such as pseudomonas, acinetobacter and candida spp. are more frequent. The insertion site is the main source of contamination and infection in short-term CVCs (10-14 days. In this case the infection is caused by migration of microorganisms along the outside of the catheter. Contamination of the hub due to frequent manipulation is usually the source of infection in long-term CVCs. In this case the infection occurs intraluminally. An effective skin disinfection is the main measure of prevention before insertion of a CVC. The aim of this measure is the elimination of transient and the reduction of resident microorganisms around the insertion site. To achieve this, disinfectants on the basis of alcohol, povidone-iodine or chlorhexidine are applied. Alcohol-based disinfectants are preferred in Central Europe because of their rapid initial effect and broad microbiological spectrum. Chlorhexidine and povidone-Iodine in contrast to alcoholic disinfectants have a remanent effect which reduces regrowth of microorganisms beyond the immediate initial effect. To which extent remanent substances reduce colonization of the CVC extraluminally or the CVC-tip is still being disputed. In an earlier clinical trial a residual or remanent effect of 0.1% octenidine combined with propanol in microbial skin decontamination over a 24h period was shown in neurosurgical patients receiving a central line (CVC or peripherally inserted central catheter). The objective of this study is therefore to evaluate further the preventive impact and tolerability of a commercially available, alcohol-based antiseptic solution containing octenidine for the preparation and care of CVC insertion sites in a clinical setting in comparison with the results given by an alcoholic solution alone.

Eligibility 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

Primary outcomes:
measure: Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection
timeFrame: For the duration of catheter placement plus 2 days
Secondary outcomes:
measure: Comparison of therapy regimens regarding side effects and complications
timeFrame: For the duration of catheter placement plus 30 days
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg
city: Basel
country: Switzerland
facility: Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel
Study officials:
affiliation: Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany
name: Markus Dettenkofer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
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