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

NCT03170505 | Completed

• 1 other identifier: 29750
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 )

Conditions

Cleft Palate

Keywords

cleft palate

Outcome Measures

Primary Outcomes (1)

• Fistula formation

  Within 2 year of surgery

Study Arms (2)

Acellular Dermal Matrix

Procedure: repairing fistula

Conchal Cartilage

Procedure: repairing fistula

Interventions

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.

Acellular Dermal Matrix; Conchal Cartilage

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the Isfahan Cleft palate Clinic with a cleft palate fistula that undergo surgical repair

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Using of Acellular Dermal Matrix in cleft palatal fistula and compare with Use of Conchal Cartolage

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: May 27, 2015
• Primary Completion: May 27, 2017
• Study Completion: May 27, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05