Cleft Palate Clinical Trial
Official title:
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
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 )
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
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