The purpose of this study is evaluation of biological scaffold chondroblastic in shaping the junction of the nose in unilateral cleft lip and nose. 40 children reffered to Hazrat Fatemeh hospital with unilateral cleft lip and nose deformity diagnostic in randomized double-blind without control with placebo and without trial phase with using sealed envelopes and on parallel divided into intrvention and control group. The patient must have age more than 10weeks, and weight morer than 10 kilogeram and patient over the age of 5 months will remove from study. In the intervention group, biological scaffolds with chondroblastic effect will used but in control group, scaffold is not used. Patients are followed for 6 months and then difference perimeter the 2 sides of the nose, the nose height, the width of the nose, tilt head of nose and weight will recorded in each group and compared with together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071612642N15
Registration date:2015-08-22, 1394/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-08-21, 1394/05/30
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of biological scaffold chondroblastic in shaping the junction of the nose in unilateral cleft lip and nose.
Public title
Effect of biological chondroblastic in shaping the junction of the nose
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Hemoglobin more than 10; age greater than 12weeks; weight more than 10 kilogeram
Exclusion criteria: َAge more than five months; Lack of parent's consent
Age
From 3 months old to 5 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is performed using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
2iums.REC.94.105.1222
Health conditions studied
1
Description of health condition studied
effect of biological chondroblastic in shaping the junction of the nose
ICD-10 code
Q30.2
ICD-10 code description
Fissured, notched and cleft nose
Primary outcomes
1
Description
Between the two sides of the nose
Timepoint
Up to 6 months after surgery and at intervals of 3 months
Method of measurement
With millimeters using Adobe Photoshop
2
Description
The height of the nose
Timepoint
Up to 6 months after surgery and at intervals of 3 months
Method of measurement
With millimeters using Adobe Photoshop
3
Description
The width of the nose
Timepoint
Up to 6 months after surgery and at intervals of 3 months
Method of measurement
With millimeters using Adobe Photoshop
Secondary outcomes
1
Description
Deviation of the nasal
Timepoint
Up to 6 months after surgery and at intervals of 3 months
Method of measurement
with degree scale using Adobe Photoshop
2
Description
weight
Timepoint
before surjery
Method of measurement
Using digital scales and scale kilogeram
Intervention groups
1
Description
The first group, biological scaffolds made of poly dioxonane made by Mentor company are used
Category
Prevention
2
Description
The second group is the control group received no interventionand biological scaffolds are not used
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Beside of Shafagh Park, Asadabadi Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Musavi
Street address
Vice chancellor for research, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Departman of Surgery, Iran University Of Medical Science
Full name of responsible person
Kamran Asadi
Position
Specialty Plastic Surgery
Other areas of specialty/work
Street address
Hazrat Fatemeh Hospital, Beside of Shafagh Park, Asadabadi Ave
City
Tehran
Postal code
Phone
+98 88717272
Fax
Email
asadi_kamran@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia group, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty intensive care
Other areas of specialty/work
Street address
Darabad ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)