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

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

1. Ages 1 month to 60 years

2. Subjects undergoing independently scheduled elective Cleft Palate of VPI repair

3. Do not meet any exclusion criteria

Exclusion Criteria:

1. Any repeat repair

2. Symptoms of upper respiratory infection

3. Immunosuppressed

4. Allergy to Amoxicillin or any other Penicillins

5. Antibiotic usage <2weeks prior to scheduled surgery other than immediate pre-operative antibiotics

6. Inability to follow up