Study of the phenytoin spray using effects in prevention of fistula after cleft palate surgery in childre

Phase 3

• Conditions: Cleft Palate.; Cleft hard palate with cleft soft palate; Q35.5

• Registration Number: IRCT20180802040678N3
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Having a combined hard and soft palate
Aged between 2 months to 2 years old

Exclusion Criteria

Revision surgery of cleft palate
Soft palate cleft only
Atypical Cleft
Past medical history of seizure and systemic diseases
Using anti convulsant, anti hypertension, and immune suppressant drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fistula Formation. Timepoint: After eight weeks. Method of measurement: Physical examination.