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

NCT ID: NCT00515151

Last Updated: 2007-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-04-30

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.

Conditions

Catheterization, Central Venous; Catheter-Associated Infections; Bacterial Infections; Bacteremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oct/Alc

Group Type: ACTIVE_COMPARATOR

0.1% Octenidine with 30% 1-propanol and 45% 2-propanol

Intervention Type: DRUG

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.

Alc

Group Type: ACTIVE_COMPARATOR

74% Ethanol with 10% 2-propanol

Intervention Type: DRUG

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.

Interventions

0.1% Octenidine with 30% 1-propanol and 45% 2-propanol

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.

Intervention Type: DRUG

74% Ethanol with 10% 2-propanol

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.

Intervention Type: DRUG

Other Intervention Names

Octeniderm; Neo-Kodan; Softasept

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Principal Investigators

Markus Dettenkofer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany

Locations

Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg

Freiburg im Breisgau, , Germany

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel

Basel, , Switzerland

Countries

Germany; Switzerland

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Other Identifiers

NEO-0102

Identifier Type: -

Identifier Source: org_study_id