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

NCT00515151 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2007-08-13

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Markus Dettenkofer, Prof. MD · Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Completion
2005-04-30

Countries

  • Germany
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515151 on ClinicalTrials.gov