Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery
Recruitment status was Not yet recruiting
|First Received Date ICMJE||January 24, 2007|
|Last Updated Date||January 24, 2007|
|Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery|
|Official Title ICMJE||Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization|
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.
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:
These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Intervention ICMJE||Procedure: samples from nostrils, mouth, axillas, perianal area and postoperative wound|
|Study Arm (s)||Not Provided|
|Publications *||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. Review.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Israel|
|NCT Number ICMJE||NCT00426894|
|Other Study ID Numbers ICMJE||yael01-HMO-CTIL|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Hadassah Medical Organization|
|Verification Date||January 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP