To evaluate the effects of phenytoin spray on the fistula formation prevention
Design
After primary repair surgery and taking informed consent, 160 patients with cleft palate consist of 80 patient in phenytoin group and 80 patient in control group conducted parallel double-blinded in the trial.
Settings and conduct
The trial performed in Tabriz Children Hospital in by managing study and control groups. Phenytoin spray 2% administerated eight weeks. Physical examination performed every two weeks and at the end, by using the SPSS the data analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Using phenytoin spray 2%, correct use the spray, regular use the spray
Exclusion criteria: Revision surgery, soft palate cleft
atypical Cleft, complication of phenytoin spray, past medical history of seizure and systemic diseases, using anti convulsant, anti hypertension, and immune suppressant drugs
Intervention groups
In the group treated with phenytoin, phenytoin spray 2% every four hours following washing and drying the mouth following feeding for eight months described and the control group not received any medication for fistula prevention
Main outcome variables
Palate fistula formation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180802040678N3
Registration date:2019-09-16, 1398/06/25
Registration timing:retrospective
Last update:2019-09-16, 1398/06/25
Update count:0
Registration date
2019-09-16, 1398/06/25
Registrant information
Name
Masoud Nouri-Vaskeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3325 9778
Email address
mnvaskeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2015-02-01, 1393/11/12
Actual recruitment start date
2010-03-01, 1388/12/10
Actual recruitment end date
2015-02-01, 1393/11/12
Trial completion date
2015-02-01, 1393/11/12
Scientific title
Study of the phenytoin spray using effects in prevention of fistula after cleft palate surgery in children
Public title
Study of the phenytoin spray using effects in prevention of fistula after cleft palate surgery in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a combined hard and soft palate
Aged between 2 months to 2 years old
Exclusion criteria:
Revision surgery of cleft palate
Soft palate cleft only
Atypical Cleft
Past medical history of seizure and systemic diseases
Using anti convulsant, anti hypertension, and immune suppressant drugs
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Children who have eligibility criteria were stratified (1:1) into the phenytoin and control groups according to their cleft palate width. Allocation to the phenytoin and control groups was performed according to randomized number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Approval date
2018-07-28, 1397/05/06
Ethics committee reference number
IR.TBZMED.REC.1397.961
Health conditions studied
1
Description of health condition studied
Cleft Palate
ICD-10 code
Q35.5
ICD-10 code description
Cleft hard palate with cleft soft palate
Primary outcomes
1
Description
Fistula Formation
Timepoint
After eight weeks
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of phenytoin spray 2% severy four hours for eight weeks
Category
Prevention
2
Description
Control group: Receiving nothing
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital of University of Medical Sciences
Full name of responsible person
Mohamad Amin Fakhriniya
Street address
Sheshgelan street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Fax
+98 41 3526 2251
Email
kodakanhospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Research Vice-Chancellor of Tabriz University of Medical Sciences
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Phone
+98 41 3335 7314
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Nouri-Vaskeh
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
516615731
Phone
+98 41 3325 9778
Email
mnvaske@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahin Abdollahi Fakhim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
abdollahifakhim85@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Amin Fakhriniya
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
aminfakhriniya@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the study is available upon approval by the University's Ethics Committee.
When the data will become available and for how long
Starting access 6 months after publication of data
To whom data/document is available
Everybody
Under which criteria data/document could be used
After communication with the corresponding author of the project, the researchers in this field can access some statistical analysis file information.
From where data/document is obtainable
Principal Investigator Dr. Shahin Abdollahi Fakhim, Department of Ear, Nose, and Throat, Tabriz University of Medical Sciences, email: abdollahifakhim85@hotmail.com
What processes are involved for a request to access data/document
After email to the corresponding author of the project, they will be able to access to the data.