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

Withdrawn before enrolling

Conditions studied: Cleft Palate

In brief

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.

Key facts

Study ID

NCT02688634

Run by

University of Florida

People needed

0

Starts

2016-04-01

Expected to finish

2018-03-01

Last updated by the study team

2017-12-21

Who can join

Age: 0 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 1 month to 60 years
• Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
• Do not meet any exclusion criteria

You may not qualify if…

• Any repeat repair
• Symptoms of upper respiratory infection
• Immunosuppressed
• Allergy to Amoxicillin or any other Penicillins
• Antibiotic usage <2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
• Inability to follow up

Where it is running

• UF Health at Shands Hospital — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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