Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-08 @ 8:10 PM
Study NCT ID:
NCT03170505
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2017-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
Sponsor:
Isfahan University of Medical Sciences
Organization:
Study Overview
Official Title:
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: