NCT00829842

Brief Summary

Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

First QC Date

January 26, 2009

Last Update Submit

January 26, 2009

Conditions

Ventilator Associated PneumoniaNosocomial PneumoniaHeart Surgery

Keywords

chlorexidineventilator-associated pneumonianosocomial pneumoniaheart surgeryoral hygiene

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Other: placebo

2

EXPERIMENTAL
Other: oral hygiene

Interventions

oral hygieneOTHER

oral hygiene with 0.12% chlorexidine

2
placeboOTHER

oral hygiene placebo

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 0 to 18 years submitted to heart surgery
  • parent approval

You may not qualify if:

  • previous oral intubation
  • previous or present pneumonia
  • parent refusal
  • death during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jacomo AD, Carmona F, Matsuno AK, Manso PH, Carlotti AP. Effect of oral hygiene with 0.12% chlorhexidine gluconate on the incidence of nosocomial pneumonia in children undergoing cardiac surgery. Infect Control Hosp Epidemiol. 2011 Jun;32(6):591-6. doi: 10.1086/660018.

    PMID: 21558772DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedHealthcare-Associated Pneumonia

Interventions

Oral Hygiene

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPreventive DentistryDentistry

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

February 1, 2006

Study Completion

February 1, 2006

Last Updated

January 27, 2009

Record last verified: 2009-01