drugset / Trial / NCT00760006

Preventing Complications in Cleft Palate Repair With Antibiotics

NCT00760006

Phase 2 Completed 224 enrolled Joseph Losee
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2008-05
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ampicillin Unknown 50 mg/kg Intravenous

Indications