Determination and comparison of shelf-life in serial transfer of autologous fat graft stored at freezing temperature and fresh fat in facial rejuvenation
Design
In this study, a single-blind randomized phase 3 clinical trial is performed in the form of parental groups. Sixty patients were divided into two groups by computer randomization.
Settings and conduct
This study was carried out in 2020 at Alzahra Hospital in Isfahan. This study was conducted as a single-blind study and the person who evaluate of the outcome of the intervention is unaware about the kind of intervention.
Participants/Inclusion and exclusion criteria
In this study, patients who are candidates for facial fat injection for the purpose of facial rejuvenation, aged 18 to 69 years, were enrolled. Patients with a history of allergies are also excluded from the study.
Intervention groups
In this study, 60 patients who were candidates for facial fat injection were divided into two groups of 30 each. In the first group, fat tissue samples are taken from the inner part of the thigh or abdomen and frozen and used repeatedly. In the second group, at each injection, fresh fat samples are taken from the patient and injected into the facial tissue.
Main outcome variables
Wrinkle-removing of nasolibial area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N43
Registration date:2020-03-16, 1398/12/26
Registration timing:prospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-17, 1399/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of survival in serial autologous fat transfer between freezed and fresh fat in face rejuvenation
Public title
Comparison of shelf life of fresh and frozen injections of facial rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for fat injection for facial rejuvenation
Patient's consent to participate in the study
Exclusion criteria:
History of any type of allergy
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients in two groups is done by Random Allocation Software. The total sample size is then entered into the software and then the number of groups is determined. The output of the software is a list containing numbers from one to 60 that are distributed randomly into two groups. According to the list, Patients are distributed into two groups according to the time of referral in order to reach the required sample size in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because of the frequency of adipose tissue differentiation between the two groups, it is not possible to blind the patient. Liposuction and injection are performed by the researcher, but the outcome of treatment and evaluation of the effects of the injection are performed by other plastic surgeon who That is unaware of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.MUI.REC..1398.288
Health conditions studied
1
Description of health condition studied
Facial wrinkles
ICD-10 code
R23.4
ICD-10 code description
changes in skin texture
Primary outcomes
1
Description
Facial Wrinkles
Timepoint
Every 3 months
Method of measurement
Modified Fitzpatrick Wrinkle Scale
2
Description
Survival Fat injected
Timepoint
every 3 months
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group,during tree time of visit, about 10 ml of fresh fat is aspirated from the inner thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The frequency of fat injections will be three times with 3 weeks interval.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this group, about 30 ml of fat is aspirated from the inner part of the thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The residual fat is freeze at -18 ° C and is injected at similar volume for the two next injections with interval of three weeks
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Enayatollah Yadollahi
Street address
Alzahra hospial, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 5555
Email
enayatolah.yadolahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayesh Haghjoo
Street address
Vice chancellor for research and technology, Isfahan University of Medical Sciences, Hezar Jerib street.
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Omranifard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 36685555
Email
omranifard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Omranifard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 36685555
Email
omranifard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
ice chancellor for research, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib street.
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 8081
Email
al.mehrabi@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
The project is owned by the government agency and its information is not available.