Status:
COMPLETED
Craniofacial Surgery Perioperative Registry
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Children's Anesthesiology Associates, Ltd.
Conditions:
Craniotomy
Eligibility:
All Genders
Up to 18 years
Brief Summary
Craniofacial reconstruction procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. These procedures involve wide scal...
Detailed Description
Craniofacial reconstructive surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. These procedures are undertaken in young children to improve...
Eligibility Criteria
Inclusion
- Males or females with ages from birth to 18 years.
- Patients undergoing surgical procedures on the craniofacial region performed by plastic surgeons, neurosurgeons, or by plastic surgeons in concert with neurosurgeons.
- 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.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion
- Patients undergoing craniofacial plastic surgical procedures not involving bones of the head and face.
- Patients not admitted to the intensive care unit following surgery.
- Patients undergoing procedures only involving the mandible.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00658242
Start Date
March 1 2008
End Date
June 1 2012
Last Update
August 9 2013
Active Locations (1)
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1
The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104