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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00515151
First received: August 10, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Catheterization, Central Venous
Catheter-Associated Infections
Bacterial Infections
Bacteremia
Drug: 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol
Drug: 74% Ethanol with 10% 2-propanol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • 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 [ Time Frame: For the duration of catheter placement plus 2 days ]

Secondary Outcome Measures:
  • Comparison of therapy regimens regarding side effects and complications [ Time Frame: For the duration of catheter placement plus 30 days ]

Enrollment: 400
Study Start Date: May 2002
Study Completion Date: April 2005
Arms Assigned Interventions
Active Comparator: Oct/Alc Drug: 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.
Other Names:
  • Octeniderm
  • Neo-Kodan
Active Comparator: Alc 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.
Other Name: Softasept

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515151

Locations
Germany
Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg
Freiburg, Germany
Switzerland
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
University Hospital Freiburg
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Markus Dettenkofer, Prof. MD Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00515151     History of Changes
Other Study ID Numbers: NEO-0102
Study First Received: August 10, 2007
Last Updated: August 10, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
Bloodstream Infection
Bacteremia
Central Venous Catheter
Alcohol
Disinfection
Octenidine Dihydrochloride

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Catheter-Related Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Octenidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014