Cleft PalateNCT03170505
Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
An observational study of Cleft Palate, run by Isfahan University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Palate
- What is being tested?
- repairing fistula
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2015to 27 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who present to the Isfahan Cleft palate Clinic with a cleft palate fistula that undergo surgical repair
Who may be able to join
- Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.
Who cannot join
- 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.
About this study
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 )
Read the detailed 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:
- hypo nasality speech after surgery
- Improvement Speech Score
- Conditions
- Cleft Palate
- Being tested
- repairing fistula
- Keywords
- cleft palate
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repairing fistulaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Not described Receives: Procedure: repairing fistula | |
| Conchal Cartilage | Not described Receives: Procedure: repairing fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula formation
Measured: Within 2 year of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start27 May 2015
- Primary completion27 May 2017
- Study completion27 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meisam AbdarEsfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170505
- Sponsor's protocol ID
- 29750
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage
- ClinicalTrials.gov ID
- NCT03170505
- Acronym / sponsor ID
- 29750
- Conditions
- Cleft Palate
- Keywords
- cleft palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 27 May 2017 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | – | Procedure: repairing fistula |
| Conchal Cartilage | – | Procedure: repairing fistula |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present to the Isfahan Cleft palate Clinic with a cleft palate fistula that undergo surgical repair
Key inclusion criteria (1 listed)
- Patients diagnosed as having cleft palate fistula, with ADM will be included in this study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repairing fistulaA tailored piece of Acellular Dermal Matrix or Conchal Cartilage will be placed between the oral and nasal layers for repair of a Cleft Palate. | Procedure or surgery | Acellular Dermal Matrix, Conchal Cartilage |
Primary outcome
Fistula formation
Time frame: Within 2 year of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula formation (time frame: Within 2 year of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.