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Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage

Cleft Palate Clinical Trial

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

Clinical Trial 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 )

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03170505
Study type Observational
Source Isfahan University of Medical Sciences
Contact
Status Completed
Phase N/A
Start date May 27, 2015
Completion date May 27, 2017
View Details
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