NCT00272675

Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (planned)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 S.aureus 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. Comparison(s): Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery

Conditions

• Nosocomial Infection
• Respiratory Tract Infection
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Chlorhexidine gluconate (drug) vs placebo

Timeline

• Start date: 2003-08-01
• Completion: 2005-09-01
• First posted: 2006-01-09
• Last updated: 2006-01-09

Locations

1 site across 1 country: Netherlands