Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
- Conditions
- Cleft Palate
- Interventions
- Procedure: repairing fistula
- Registration Number
- NCT03170505
- Lead Sponsor
- Isfahan University of Medical Sciences
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acellular Dermal Matrix repairing fistula - Conchal Cartilage repairing fistula -
- Primary Outcome Measures
Name Time Method Fistula formation Within 2 year of surgery
- Secondary Outcome Measures
Name Time Method