Cardiac SurgeryNCT00426894
Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery
A study testing samples from nostrils, mouth, axillas, perianal area and postoperative wound in people with Cardiac Surgery and Perioperative Prophylaxis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Perioperative Prophylaxis
- What is being tested?
- samples from nostrils, mouth, axillas, perianal area and postoperative wound
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Hospital
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Cardiac Surgery, Perioperative Prophylaxis
- Being tested
- samples from nostrils, mouth, axillas, perianal area and postoperative wound
- Keywords
- surveillance cultures, children, cardiac surgery, perioperative prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samples from nostrils, mouth, axillas, perianal area and postoperative woundProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Dina Averbuch, MD, Principal investigator, Hadassah University Hospital, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426894
- Sponsor's protocol ID
- yael01-HMO-CTIL
- Status last verified
- Jan 2007
- First submitted
- 24 Jan 2007
- Last updated
- 25 Jan 2007
- Results posted
- No
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. doi: 10.1016/j.amjsurg.2005.01.015.
PubMed 15820449
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization
- ClinicalTrials.gov ID
- NCT00426894
- Acronym / sponsor ID
- yael01-HMO-CTIL
- Conditions
- Cardiac Surgery, Perioperative Prophylaxis
- Keywords
- surveillance cultures, children, cardiac surgery, perioperative prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 25 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| samples from nostrils, mouth, axillas, perianal area and postoperative wound | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2007.
- Background: PubMed 15820449Bratzler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Averbuch, MD principal investigator
Hadassah University Hospital, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing samples from nostrils, mouth, axillas, perianal area and postoperative wound in people with Cardiac Surgery and Perioperative Prophylaxis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Averbuch, MD (972-50-7874940, dina8282@walla.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00426894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2007.