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

Cleft Palate Clinical Trial

— Cleft Palate  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02688634
• Other study ID #: IRB201500667
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2016
• Last updated: December 19, 2017
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: December 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate
• Velopharyngeal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health at Shands Hospital	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rates between the groups	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 ?2 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.	30 days
Primary	Dehiscence and fistula formation between the groups	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.	30 days