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

Study Overview
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Brief Summary
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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
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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

Official 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.

Conditions
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Nosocomial Infection, Respiratory Tract Infection, Surgical Site Infection

Intervention / Treatment
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* Drug: Chlorhexidine gluconate (drug) vs placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chlorhexidine gluconate (drug) vs placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nosocomial Infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nosocomial infection,, Decontamination,, Randomized placebo-controlled trial,, Cardiac surgery,, Chlorhexidine,, Prevention