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

Withdrawn

• Conditions: Cleft Palate
• Interventions: Drug: Amoxicillin

• Registration Number: NCT02688634
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-23
• Study Start: 2016-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Amoxicillin	Participants in this group are randomize to receive post-operative antibiotic of Amoxicillin x7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.

Primary Outcome Measures

Name	Time	Method
Infection rates between the groups	30 days	Analysis of infection is based on a 7 point scale to allow for broadened data but can be evaluated in a binary fashion for ≥ 4 indicating infection and \<4 as no infection. A χ2 test and Fisher's exact test for p\<0.05 will be used to determine significance of the difference in complication (cellulitis and upper respiratory infection) rates between the two groups.
Dehiscence and fistula formation between the groups	30 days	Both dehiscence and fistula formation will also be recorded as a binary present/not present data point to determine the significance of the difference in complication rates between the groups.

Trial Locations

Locations (2)

UF Health at Shands Hospital; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States