Status:
COMPLETED
Preventing Complications in Cleft Palate Repair With Antibiotics
Lead Sponsor:
Joseph Losee
Conditions:
Cleft Palates
Eligibility:
All Genders
3-18 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft s...
Detailed Description
During the initial clinical visit, the clinical diagnosis of a cleft secondary palate or submucous cleft will be made. Other associated clinical findings such as unilateral/bilateral cleft lip, unilat...
Eligibility Criteria
Inclusion
- Children diagnosed as having cleft palates undergoing palatoplasty between the ages of 3 months and 18 years will be included in this study. Palatoplasty is the current standard of care in the sequence of treatment for cleft secondary palates. Pediatric plastic surgeons work primarily with children, and have undergone extensive training during their residencies and pediatric surgical fellowships to do so. Children will be evaluated initially at the Cleft-Craniofacial Center at the Children's Hospital of Pittsburgh of UPMC, which is set up to accommodate children of all ages and their families. Approximately 300 children will be required to contribute to a meaningful analysis.
Exclusion
- All patients requiring prophylactic antibiotics for spontaneous bacterial endocarditis, with documented allergic reactions to the ampicillin-sulbactam, and with known immunodeficiencies or immunodeficiency associated syndromes, such as the 22q chromosomal deletion, will be excluded from study participation.
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or the placebo groups
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00760006
Start Date
May 1 2008
End Date
August 1 2015
Last Update
February 1 2018
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213