Cleft Palate
Conditions
Keywords
cleft palate
Brief summary
The fact that still exist is which method for repairing of secondary cleft palatal fistula is the best. This study will have shown whether using of Acellular dermal Matrix decreased the fistula formation versus using Conchal Cartilage during secondary fistula. Among studies that published, they have not consensus for using acellular dermal matrix. Most of the questions are about cost effectiveness, time that surgery and rehabilitation need and patient risk ( risk of transmission disease from other human tissue )
Detailed description
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group with Conchal Cartilage. Primary objectives: The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing secondary cleft palate fistula repair. Secondary objectives: 1. hypo nasality speech after surgery 2. Improvement Speech Score
Interventions
PROCEDURErepairing fistula
A tailored piece of Acellular Dermal Matrix or Conchal Cartilage will be placed between the oral and nasal layers for repair of a Cleft Palate.
Sponsors
Isfahan University of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.
Exclusion criteria
* Selection will be based on the patient's willingness to allow to participate in the study. * Patients with diagnosed craniofacial syndromes will be excluded from the study. * Children with known wound healing defects, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula formation | Within 2 year of surgery |
Outcome results
None listed