At a glance
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Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates
In Brief
A Phase 2 clinical trial evaluating Unasyn and saline solution for Cleft Palates. Completed, enrolled 224 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.