Evaluating the effectiveness of platelet-rich fibrin injection in diced cartilage survival rate in rhinoplasty
Design
A clinical trial with a control group, with crossover groups, one-sided blind, randomized, on 40 patients, randomization was computerized with RAND function of Excel.
Settings and conduct
This study is a randomized controlled clinical trial one blinded. Patients are randomly placed in one of the coded groups and will undergo rhinoplasty, and the patient does not know about the procedure. Patients who are candidates for rhinoplasty and do not have a history of hematological diseases will be included in the study after obtaining written consent, and their information, including age, gender, underlying diseases, and medications will be extracted from the file. Patients will be placed in one of the groups after randomization. After treatment, patients are evaluated by ultrasound (cartilage survival rate), Utrecht questionnaire (patient satisfaction), and nose examination by a skilled surgeon (evaluation of cartilage irregularities in four injection sites).
Participants/Inclusion and exclusion criteria
Rhinoplasty candidate
Absence of hematologic diseases
Intervention groups
Control group: patients who are operated with diced cartilage during rhinoplasty.
PRF group: patients who are operated with diced cartilage and PRF during rhinoplasty.
Main outcome variables
The survival rate of remaining cartilage in volume scale (ultrasound)
Assessment of injection site irregularities in four points (nasal examination by a skilled surgeon)
Patient satisfaction (Utrecht questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221011056150N1
Registration date:2023-01-07, 1401/10/17
Registration timing:retrospective
Last update:2023-01-07, 1401/10/17
Update count:0
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Elham Zahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4494 3270
Email address
zahabie71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
2020-05-21, 1399/03/01
Actual recruitment end date
2021-09-23, 1400/07/01
Trial completion date
2021-09-23, 1400/07/01
Scientific title
Evaluating the effectiveness of Platelet-Rich Fibrin on the survival of Diced cartilage in rhinoplasty candidate patients
Public title
Evaluating the effect of Platelet-Rich Fibrin on the survival of Diced cartilage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rhinoplasty candidate patients
Exclusion criteria:
Hematologic diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are placed in one of the two groups of rhinoplasty without PRF (group A) or rhinoplasty with PRF (group B). Randomization is done based on the (RAND) function of Excel software and based on this, a table of random numbers is prepared, and patients are placed in groups A or B according to the rows of this table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the intervention is of surgical type, only the patients have been kept blind and the surgeon and clinical assessor and those responsible for data collection know about the grouping of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.IUMS.FMD.REC.1399.150
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sonographic result
Timepoint
One year after surgery
Method of measurement
Ultrasound (cartilage viability)
2
Description
Clinical examination of skilled surgeon
Timepoint
One year after surgery
Method of measurement
Grading by the surgeon - Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage mixed with platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon.
Category
Treatment - Surgery
2
Description
Control group: includes 20 rhinoplasty candidates who meet the inclusion criteria, whose order and type of intervention is randomly based on the (RND) function of Excel software. These patients receive diced cartilage without platelet-rich fibrin during rhinoplasty. One year after the surgery, the cartilage is evaluated by ultrasound and evaluations by a skilled surgeon.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Alireza Mohebi
Street address
Niyayesh Ave. Satarkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2417
Fax
Email
mohebbi@ariums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Hemat High way, next Milad tower
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2417
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Elham Zahabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 22/9 , North bahar St , west ferdous Blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 4494 3270
Fax
Email
zahabie71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Zahabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 22/9 , North bahar St , west ferdous Blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 4494 3270
Fax
Email
zahabie71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Zahabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 22/9 , North bahar St , west ferdous Blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 4494 3270
Fax
Email
zahabie71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available