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

NCT ID: NCT03170505

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-27

Study Completion Date

2017-05-27

Brief Summary

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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

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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

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Cleft Palate

Keywords

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cleft palate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acellular Dermal Matrix

repairing fistula

Intervention Type PROCEDURE

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.

Conchal Cartilage

repairing fistula

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Meisam AbdarEsfahani

Using of Acellular Dermal Matrix in cleft palatal fistula and compare with Use of Conchal Cartolage

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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29750

Identifier Type: -

Identifier Source: org_study_id