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

Isfahan University of Medical Sciences

Status: Completed

Conditions: Cleft Palate

Treatments: Procedure: repairing fistula

Study type: Observational

Funder types: Other

Identifiers

NCT03170505

29750

Details and patient eligibility

About

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 )

Full 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

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.

Exclusion criteria

• 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.

Trial design

60 participants in 2 patient groups

Acellular Dermal Matrix

Treatment:

Procedure: repairing fistula

Conchal Cartilage

Treatment:

Procedure: repairing fistula