ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 6 for:    "Velopharyngeal Insufficiency"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02688634
Recruitment Status : Withdrawn
First Posted : February 23, 2016
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cleft Palate Drug: Amoxicillin

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018


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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688634


Locations
United States, Florida
UF Health at Shands Hospital
Gainesville, Florida, United States, 32610
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Ashley Lentz, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02688634     History of Changes
Other Study ID Numbers: IRB201500667
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Cleft Palate Surgery
Antibiotic treatment

Additional relevant MeSH terms:
Velopharyngeal Insufficiency
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents