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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00658242 |
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Date of registration:
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08/04/2008 |
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Primary sponsor: |
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Public title:
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Craniofacial Surgery Perioperative Registry
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Scientific title:
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Craniofacial Surgery Perioperative Registry |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00658242 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul A Stricker, MD |
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Address:
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Telephone:
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215-590-1876 |
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Email:
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strickerp@email.chop.edu |
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Affiliation:
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Name:
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Paul A Stricker, MD |
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Address:
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Telephone:
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215-590-1876 |
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Email:
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strickerp@email.chop.edu |
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Affiliation:
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Name:
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Paul A Stricker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males or females with ages from birth to 18 years.
2. Patients undergoing surgical procedures on the craniofacial region performed by
plastic surgeons, neurosurgeons, or by plastic surgeons in concert with
neurosurgeons.
3. Patients undergoing plastic surgical procedures involving a craniotomy, craniectomy,
maxillofacial osteotomy, strip craniectomy, or other plastic surgical procedure
involving bones of the head and face.
4. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria:
1. Patients undergoing craniofacial plastic surgical procedures not involving bones of
the head and face.
2. Patients not admitted to the intensive care unit following surgery.
3. Patients undergoing procedures only involving the mandible.
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Craniotomy
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Primary Outcome(s)
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To create a research tool that prospectively captures perioperative data in the craniofacial surgical patient population that may provide insights into the perioperative management and help guide clinical decision making.
[Time Frame: 2.5 years]
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Secondary ID(s)
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2008-3-5842
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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