Evaluation of the effect of topical injection of platelet-rich fibrin on the thickness of nasal skin in people undergoing rhinoplasty by ultrasonography
Determining the relationship between platelet-rich fibrin injection and the quality of nasal skin thickness using nasal skin ultrasound
Design
A clinical trial without a control group, non-randomized, with a sample size of 10 people (comparison before and after the intervention)
Settings and conduct
Masih Deneshvari hospital is the otolaryngology clinic. 30 cc of venous blood sample is taken from the person's blood and collected in 15 ml plastic coated tubes without using anticoagulants. Then the tubes are immediately placed opposite each other inside the centrifuge and centrifuged at 800 revolutions per minute for four minutes. The yellow-orange upper liquid obtained is ready for injection. The above actions are performed with all aseptic precautions. The participants undergo ultrasound examination once before the injection and three times after the injection in order to compare the thickness of the nasal skin. And the skin thickness of people before and after injection is compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: who want rhinoplasty or a history of rhinoplasty surgury
Exclusion criteria: history cancer of sinus and nose, diabetes , platelet dysfunction
Intervention groups
The intervention group includes people who had a history of rhinoplasty surgery or are planning to undergo rhinoplasty surgery, who are injected with fibrin solution rich in platelets. The participants undergo ultrasound examination once before the injection and three times after the injection in order to compare the thickness of the nasal skin. And the skin thickness of people before and after injection is compared
Main outcome variables
Examination of the quality of the nasal skin and the thickness of the nasal skin; The amount of blood supply in the skin of the nose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190423043360N1
Registration date:2023-02-27, 1401/12/08
Registration timing:retrospective
Last update:2023-02-27, 1401/12/08
Update count:0
Registration date
2023-02-27, 1401/12/08
Registrant information
Name
Jahangir Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 5242
Email address
jghorbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical injection of platelet-rich fibrin on the thickness of nasal skin in people undergoing rhinoplasty by ultrasonography
Public title
Investigation of the effect of platelet-rich fibrin on skin thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
who want rhinoplasty or have a history of rhinoplasty
Exclusion criteria:
History of nasal and sinus cancer
diabetes
disease of Impairment of wound tissue repair
Blood platelet disorders and the use of anticoagulants
History of platelet-rich fibrin injection
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The effectiveness of platelet-rich fibrin on improving the thickness of nasal skin has not been studied in Iran
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran Darabad Masih daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2021-12-02, 1400/09/11
Ethics committee reference number
IR.SBMU.NRITLD.REC.1400.078
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of injection of platelet-rich fibrin on the thickness of the nasal skin
Timepoint
Examination of skin thickness with ultrasound before injection and one week, two weeks and three weeks after
Method of measurement
Thickness in the dermis, epidermis and subcutaneous tissue is measured and measured. Equipment used for Medison sonoac 8000se ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
After a complete explanation about the study and obtaining their consent, first 30 cc of venous blood samples are taken from the person's blood and collected in 15 ml plastic coated tubes without the use of anticoagulants. Then the tubes are immediately placed opposite each other inside the centrifuge and centrifuged at 800 revolutions per minute for four minutes. The yellow-orange upper liquid obtained is ready for injection. The above actions are performed with all aseptic precautions. The participants undergo ultrasound examination four times in order to compare the thickness of the nasal skin. The first stage is before the injection and the next three stages are one, two and three weeks after the injection. Ultrasound will be performed by a high-frequency linear probe by the center's expert radiologists who are familiar with ultrasound. During the ultrasound process, the thickness of the skin along with changes in echogenicity and the presence of vascularity will be checked and compared with the thickness before the injection. The thickness in the dermis, epidermis and subcutaneous tissue is checked and measured. The equipment used for ultrasound is Medison sonoac 8000se at a frequency of 5-9 MHz.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih daneshvari hospital
Full name of responsible person
Jahangir Ghorbani
Street address
Tehran. Darabad St. Masih daneshvari hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3812
Email
jghorbani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jahangir Ghorbani
Street address
Teharan Darabad St Masih daneshvari hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2813
Email
jghorbani@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jahangir Ghorbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Masih daneshvari hospital, Darabar st, Tehran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3812
Email
jjghorbani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jahangir Ghorbani
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Darabad, Massih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5242
Fax
Email
jghorbani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jahangir Ghorbani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Masih daneshvari hospital, Darabar st, Tehran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3812
Email
jjghorbani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD