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OpenTrials
Completed

NCT Number: NCT03170505

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

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 )

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • hypo nasality speech after surgery
  • Improvement Speech Score

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repairing fistula

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.

Primary outcomes

  1. Fistula formation

    Time frame: Within 2 year of surgery

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 31, 2017
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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