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

NCT02688634 | Withdrawn

• 1 other identifier: IRB201500667
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Cleft Palate

Keywords

Cleft Palate Surgery; Antibiotic treatment

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

Study Arms (2)

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

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.

Interventions

Amoxicillin DRUG

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.

Also known as: Antibiotics

Treatment

Eligibility Criteria

• Age: 1 Month - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Ages 1 month to 60 years
• Subjects undergoing independently scheduled elective Cleft Palate of VPI repair

You may not qualify if:

• Any repeat repair
• Symptoms of upper respiratory infection
• Immunosuppressed
• Allergy to Amoxicillin or any other Penicillins
• Antibiotic usage \<2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
• Inability to follow up

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Health at Shands Hospital

Gainesville, Florida, 32610, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cleft Palate

Interventions

Amoxicillin; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ashley Lentz, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)