Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:30 AM
Study NCT ID:
NCT00426894
Status:
UNKNOWN
Last Update Posted:
2007-01-25
First Post:
2007-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: