NCT03170505

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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

Conditions

• Cleft Palate

Interventions

Type	Name	Description
PROCEDURE	repairing 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.

Timeline

• Start date: 2015-05-27
• Primary completion: 2017-05-27
• Completion: 2017-05-27
• First posted: 2017-05-31
• Last updated: 2017-05-31