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 Details — Status: Completed

Administrative data

• NCT number: NCT03170505
• Other study ID #: 29750
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: May 26, 2017
• Start date: May 27, 2015
• Est. completion date: May 27, 2017

Study information

• Verified date: May 2017
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 )

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 27, 2017
• Est. primary completion date: May 27, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Fistula

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula formation		Within 2 year of surgery