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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00272675 |
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Date of registration:
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04/01/2006 |
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Primary sponsor: |
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Public title:
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Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)
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Scientific title:
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Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00272675 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Patrique Segers, Drs. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Center Amsterdam |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all adult patients (above 18) who were scheduled to undergo sternotomy for
cardiothoracic surgery
Exclusion Criteria:
- emergency procedures, a preoperative infection and/or the use of antibiotics,
hypersensitivity to chlorhexidine gluconate (CHX), absence of written informed
consent or presence of an alternative prophylactic regimen like selective
decontamination of the digestive tract
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nosocomial Infection
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Respiratory Tract Infection
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Surgical Site Infection
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Intervention(s)
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Drug: Chlorhexidine gluconate (drug) vs placebo
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Primary Outcome(s)
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Nosocomial Infection
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Secondary Outcome(s)
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Respiratory tract and surgical site infection; S. aureus nasal carriage, nonprophylactic antibiotic use, hospital stay, in-hospital mortality, optimal duration of preoperative trial medication and medication adverse-effects.
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Secondary ID(s)
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WO-03.021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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