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Preventing Complications in Cleft Palate Repair With Antibiotics

NCT00760006 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-02-01

Study results available
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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

Conditions

  • Cleft Palates

Interventions

DRUG

Unasyn

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

OTHER

saline solution

Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.

Sponsors & Collaborators

  • Joseph Losee

    lead OTHER

Principal Investigators

  • Joseph Losee, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760006 on ClinicalTrials.gov