Preventing Complications in Cleft Palate Repair With Antibiotics

Launched by JOSEPH LOSEE · Sep 24, 2008

Keywords

ClinConnect Summary

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, unilateral/bilateral cleft primary palate, Veau cleft palate classification, and associated syndromic diagnosis will be recorded. The severity of the cleft palate will be documented by measuring the width of the cleft and the hard-soft palate juncture. The patients will proceed through the standardized cleft treatment protocol as mandated by their specific anatomic findings. These include possible na...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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