Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

H

Hadassah Medical Center

Status

Unknown

Conditions

Perioperative Prophylaxis
Cardiac Surgery

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00426894
yael01-HMO-CTIL

Details and patient eligibility

About

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.

Full description

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: on admission to Pediatric Surgery or other department pre-operatively once weekly afterwards, if they continue to be hospitalized without surgery on admission to PICU after surgery during their subsequent hospitalization in PICU after 3 - 5 days on the day of drains extraction These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Hadas Lemberg, PhD; Dina Averbuch, MD

Data sourced from clinicaltrials.gov

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