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

University of Florida

Status: Withdrawn

Conditions: Cleft Palate

Treatments: Drug: Amoxicillin

Study type: Observational

Funder types: Other

Identifiers

NCT02688634

IRB201500667

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 month to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Treatment

Description:

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.

Treatment:

Drug: Amoxicillin

Non-Treatment

Description:

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.