NCT02688634

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 1 Month – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.

Conditions

• Cleft Palate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-02-23
• Last updated: 2017-12-21

Locations

2 sites across 1 country: United States