Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00426894|
Recruitment Status : Unknown
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : January 25, 2007
Last Update Posted : January 25, 2007
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery Perioperative Prophylaxis||Procedure: samples from nostrils, mouth, axillas, perianal area and postoperative wound||Not Applicable|
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.
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization|
|Study Start Date :||January 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426894
|Contact: Dina Averbuch, MDfirstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||972 2 email@example.com|
|Hadassah University Hospital||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Diana Averbuch, MD|
|Sub-Investigator: Shmuel Benenson, MD|
|Sub-Investigator: Ido Yatsiv, MD|
|Sub-Investigator: Eli Milgalter, MD|
|Sub-Investigator: Matan J Cohen, MD MPh|
|Principal Investigator:||Dina Averbuch, MD||Hadassah University Hospital, Jerusalem, Israel|