Preventing Complications in Cleft Palate Repair With Antibiotics
Condition: Cleft Palates
MeSH terms: Cleft Palate
Intervention: Unasyn; saline solution
Intervention description: Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for this study is off-label as with the majority of antibiotics used with children. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm; Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.
Intervention MeSH terms: Ampicillin; Sulbactam; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 3 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: cleft secondary palate; primary closure of secondary cleft palate; Prophylactic Antibiotics; Unasyn; Cleft Palate

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 secondary palate. Secondary objective of this study is to evaluate the
      effects of preoperative antibiotics administered on post operative outcome following primary
      closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic
      antibiotics in cleft surgery to

        -  decrease the incidence of surgical sight infections

        -  speed the progression of postoperative healing

        -  improve the final quality of wound healing achieved

        -  decrease the rate of palatal fistula formation
    

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