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The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

NCT02688634 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-12-21

No results posted yet for this study

Summary

Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.

Conditions

  • Cleft Palate

Interventions

DRUG

Amoxicillin

Amoxicillin will be given as: 7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Ashley Lentz, MD · University of Florida

Eligibility

Min Age
1 Month
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

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 NCT02688634 on ClinicalTrials.gov