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

December 19, 2017 updated by: University of Florida
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32610
        • UF Health at Shands hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
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.
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.
Other Names:
  • Antibiotics
Non-Treatment
Participants in this group will be randomize to no post-operative antibiotic. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection rates between the groups
Time Frame: 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.
30 days
Dehiscence and fistula formation between the groups
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Ashley Lentz, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201500667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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