Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272675
Status:
COMPLETED
Last Update Posted:
2006-01-09
First Post:
2006-01-04
Brief Title:
Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine NONI Trial
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine A Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Does chlorhexidine gluonate a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery especially with respect to LTI and SSI
Detailed Description:
Nosocomial infections NIs after open heart surgery are recognized as an important cause of morbidity and mortality with a prolonged hospital stay increased need for of antibiotics decreased quality of life and higher concomitant costs Decontamination of the oropharynx seems important since there is direct evidence of an association between pulmonary infection and oral health Another important strategy involves the eradication of Staphylococcus aureus the most important pathogen causing SSI The most common reservoir of Saureus is the anterior nares and eradication can be achieved by the application of topical antibiotics Although promising results have been reported for both strategies they are not widely used as routine prevention methods because of the variability of trial design the concern about the emergence of antimicrobial resistance and increased costs Further research is essential to evaluate different protocols antimicrobial agents and cost-effectiveness
Fur this purpose we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of NI after cardiac surgery especially with respect to LTI and SSI
Comparisons Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery
Fur this purpose we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of NI after cardiac surgery especially with respect to LTI and SSI
Comparisons Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None