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

Original Study ID : WO-03.021

NCT ID : NCT00272675

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

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.

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?

Source : Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Overall Status : Completed

Start Date : August 2003

End Date : September 2005

Completion Date : September 2005

Official Title : Phase 2/Phase 3

Phase : Interventional

Study Design : Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Enrollment : 1000

Verification Date : January 2006

First Received Date : January 4, 2006

Trial Eligibility

Criteria :
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Onze lieve vrouwe gasthuis

City : Amsterdam

Zip Code : 1090 HM

Country : Netherlands

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