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Sponsors and Collaborators: |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Dept of cardiothoracic surgery Academic Medical Center Dept of cardiothoracic surgery Onze Lieve Vrouwe Gasthuis Amsterdam |
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Information provided by: | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT00272675 |
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 |
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Nosocomial Infection Respiratory Tract Infection Surgical Site Infection |
Drug: Chlorhexidine gluconate (drug) vs placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 1000 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | September 2005 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Onze lieve vrouwe gasthuis | |
Amsterdam, Netherlands, 1090 HM |
Principal Investigator: | Patrique Segers, Drs. | Academic Medical Center Amsterdam |
Study ID Numbers: | WO-03.021 |
Study First Received: | January 4, 2006 |
Last Updated: | January 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00272675 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Nosocomial infection, Decontamination, Randomized placebo-controlled trial, |
Cardiac surgery, Chlorhexidine, Prevention |
Chlorhexidine Respiratory Tract Diseases Respiratory Tract Infections Chlorhexidine gluconate Cross Infection |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |