Antibiotics and Cleft Palate Repair

Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates

Protocol Description

This study will help researchers determine if giving a single dose of antibiotic to a patient just before cleft palate surgery will improve the result of the surgery. It is not known whether children who receive antibiotics have less infection and better healing as compared to children who do not receive antibiotics.

Eligibility Criteria

Children ages 3 months through 18 years who are diagnosed with a cleft palate requiring surgery will be eligible for participation.
Boys: 3 months through age 18
Girls: 3 months through age 18

Requirements

By randomization, participants in this study will be given either an antibiotic or a saline placebo, intravenously, prior to surgery. Each patient will be closely monitored for any signs of infection or reaction, and the quality of healing and recovery will also be recorded.
Visits: None beyond standard care for cleft palate
Duration: Not applicable

Status: Open for Enrollment

Primary Investigator

Joseph E. Losee, MD, FACS, FAAP

Contact Information

To get started, please contact:
Jennifer Szczepaniak, BS
412-692-6203