Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

NCT ID: NCT00426894

Last Updated: 2007-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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the purpose of this study is to determine whether children who are hospitalised waiting for cardiac surgery for several days in pediatric or pediatric surgery department acquire resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative prophylaxis.

Detailed Description

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Background

Guidelines for antimicrobial prophylaxis for cardiac surgery advise using first generation cephalosporin for those children coming from home. Large number of children that pass cardiac surgery in Hadassah University Hospital, Jerusalem, are hospitalized for several days before the operation in Pediatric Surgery department due to administrative reasons. These children receive broad spectrum antibiotics, vancomycin and ceftazidime, as a peri-operative prophylaxis, in order to prevent infection with hospital acquired flora with which they could become colonized with during this period. This policy causes exposure to broad spectrum antibiotics from the beginning in these children, and also providing an antimicrobial pressure in the intensive care unit, influencing the development of resistant flora.

There is no documentation that these children acquire resistant flora during there hospitalization in the pre-operative period. We suggest checking microbial flora in those children hospitalized for cardiac surgery, in order to determine the need for broad spectrum antimicrobial prophylaxis.

Goals

To check microbial flora in children hospitalized for cardiac surgery on different time points: on admission and during hospitalization in Pediatric Surgery Department, on admission to PICU (immediately after operation),after 3 - 5 days,when drains are extracted.

To document if there is a change in resistance pattern of microbial pathogens during these periods

To determine the optimal regimen for antimicrobial prophylaxis for those children who need to be hospitalized in this department before the operation

Methods

Surveillance cultures would be taken from children who are hospitalized for cardiac surgery on several time points:

1. on admission to Pediatric Surgery or other department pre-operatively
2. once weekly afterwards, if they continue to be hospitalized without surgery
3. on admission to PICU after surgery
4. during their subsequent hospitalization in PICU after 3 - 5 days
5. on the day of drains extraction

These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.

Conditions

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Cardiac Surgery Perioperative Prophylaxis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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samples from nostrils, mouth, axillas, perianal area and postoperative wound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Dina Averbuch, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital, Jerusalem, Israel

Locations

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Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dina Averbuch, MD

Role: CONTACT

972-50-7874940

Hadas Lemberg, PhD

Role: CONTACT

972 2 6777572

Facility Contacts

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Arik Tzukert, DMD

Role: primary

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

References

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Bratzler DW, Houck PM; Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005 Apr;189(4):395-404. doi: 10.1016/j.amjsurg.2005.01.015.

Reference Type BACKGROUND
PMID: 15820449 (View on PubMed)

Other Identifiers

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yael01-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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