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

This study has been completed.
Onze Lieve Vrouwe Gasthuis
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier:
First received: January 4, 2006
Last updated: January 6, 2006
Last verified: January 2006
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?

Condition Intervention Phase
Nosocomial Infection
Respiratory Tract Infection
Surgical Site Infection
Drug: Chlorhexidine gluconate (drug) vs placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Nosocomial Infection

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1000
Study Start Date: August 2003
Estimated Study Completion Date: September 2005
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00272675

Onze lieve vrouwe gasthuis
Amsterdam, Netherlands, 1090 HM
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Onze Lieve Vrouwe Gasthuis
Principal Investigator: Patrique Segers, Drs. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00272675     History of Changes
Other Study ID Numbers: WO-03.021
Study First Received: January 4, 2006
Last Updated: January 6, 2006

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Nosocomial infection,
Randomized placebo-controlled trial,
Cardiac surgery,

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Surgical Wound Infection
Cross Infection
Respiratory Tract Diseases
Wound Infection
Iatrogenic Disease
Disease Attributes
Postoperative Complications
Pathologic Processes
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents processed this record on May 25, 2017