The aim of the present study is to evaluate the effect of spreader graft in aesthetic of nasal dorsum after primary rhinoplasty. This study is randomized, double blind, with control, single center, phase-2 of clinical trial. Blinding is done for patients and researcher who measures the outcomes. The main inclusion criterion is: The patient must be in ASA CL 1 classification and with no contraindication for nasal surgery. The main exclusion criteria are history of trauma before and after surgical procedure, nasal asymmetry, dorsal hump reduction more than 3 mm, presence of hypertrophic turbinate, consumtion of drugs which intervene blood coagulation. Target sample size is 20 patients. In intervention group spreader graft is placed and in control group is not placed. The time of this study is 6 months. Primary outcome is placing spreader graft.
General information
Acronym
:
IRCT registration information
IRCT registration number:IRCT201702049926N5
Registration date:2017-05-10, 1396/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Mohammad Reza Jamalpour
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1826 0356
Email address
jamalpour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-08, 1396/02/18
Expected recruitment end date
2017-11-08, 1396/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of spreader graft in aesthetic of nasal dorsum after primary rhinoplasty; A randomized double blind clinical trials.
Public title
Effect of spreader graft on aesthetic of nose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion and Exclusion criteria: ( Inclusion criteria: Should be in American Society Of Anesthesiologist Cl I classification; No contraindication for nose surgery Exclusion criteria; Hx of trauma before and after surgical procedure; Nasal asymmetry; Respiratory problem; Nasal dorsal hump reduction more than 3 mm; Presence of scar on nasal skin; Presence of hypertrophic turbinate; Presence of concha bllusa; consumption of drugs which intervene blood coagulation )
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of Hamadan University of Medical Sciences
Street address
no.16, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.umsha.REC.1395.480
Health conditions studied
1
Description of health condition studied
Nasal deformity
ICD-10 code
Q30
ICD-10 code description
Congenital malformation of nose
Primary outcomes
1
Description
Aesthetic of nasal dorsum
Timepoint
6 months
Method of measurement
Observation
Secondary outcomes
1
Description
Satisfaction of patient
Timepoint
6 month
Method of measurement
Questionaire
2
Description
Asymmetry of dorsum
Timepoint
6 month
Method of measurement
Assessment of surgeon
3
Description
Depression of dorsum
Timepoint
6 month
Method of measurement
Assessment of surgeon
4
Description
Wideness of dorsum
Timepoint
6 month
Method of measurement
Assessment of surgeon
5
Description
Step
Timepoint
6 month
Method of measurement
Assessment of surgeon
Intervention groups
1
Description
Placing spreader graft
Category
Treatment - Surgery
2
Description
Spreader graft is not placed
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr Mohammadresa Jamalpour
Street address
No 20, Mazdaghine Street, Shahid Beheshti Street
City
hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellors of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Askarinia
Street address
No.14, Vice-chancellors of Research and Technology,Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellors of Research and Technology, Hamadan 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
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Jamalpour
Position
Associated professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No 18,Shahid Fahmideh street,Ganjname street
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
jamaipou@umsha.ac.ir
Email
jamalpour@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Jamalpour
Position
Associated Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No 18, Shahid Fahmide Street, Ganjname street
City
Hamadan
Postal code
Hamadan
Phone
+98 81 3838 1059
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan U niversity of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Jamalpour
Position
Associated professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
No 18, Shahid Fahmide street, Ganjname Street
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
jamalpour@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)