Analyze the qualitative impact of using autologous fat injection to treat burn scars in comparison to using normal saline to treat scars.
Design
Randomized double blind parallel group controlled clinical trial on 18 patients (36 samples) randomization with sealed envelope
Settings and conduct
Chronic burn patients were referred to Hazrat Fatemeh Hospital and Motahari Hospital in Tehran.
Venue: Hazrat Fatemeh Hospital/Motahari Hospital
Method: Mark the desired scar for intervention, divide it into two halves and perform the described interventions in the operating room under general anesthesia by a plastic and reconstructive surgery specialist.
Randomization: Using a sealed envelope
Blinded group: principal investigator, outcome assessor, patient, and health care providers after the intervention compared to the half-intervention or control
Unblinded group: surgeon performing the procedure
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patient older than 18 years old
2 - Having a burn scar
3- At least one year has passed since the burn injury
Exclusion criteria:
1. Any serious systemic disease that puts the patient at a higher risk for general anesthesia.
Intervention groups
Intervention group: patients with burn scars in the marked half of the scar who receive fat injection intervention in the subdermal area.
Control group: patients with burn scars in the marked half of the scar who receive the intervention of normal saline injection in the subdermal area.
Evaluation of the effectiveness of autologous fat transfer on the quality of burn-induced scars
Public title
A randomized controlled double-blinded clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Burn-induced scars anywhere on the trunk or limbs or face or neck
The minimal interval between burn injury and intervention(fat grafting) should not be less than one year(Mature Scars)
Exclusion criteria:
Any significant systemic disease or morbidity ( e.g. Cardiac disease, Endocrine disease, Respiratory Disease etc)
Any patient with an American Society of Anesthesiologist Physical Status Classification System score>II indicating increased anesthesia risk
Low Body Mass Index (BMI) (Less than 19kg/m²)
Known Systemic Immune Disorder (Acquired or inherited immune deficiency)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Scar quality assessment based on the Patient Observer Scar Assessment Scale (POSAS) measured before intervention and 3 months after intervention in two scar halves (Autologous fat injection versus normal saline)
Randomization (investigator's opinion)
Randomized
Randomization description
Every patient will be coded with the letter A or B using sealed envelopes.
Each scar will be divided into two halves: A will be right or Up and B means left or down half. Group A will be injected with fat in right or upside half of the targeted scar and injected with normal saline in the left or downside half of the targeted scar. Group B will be injected with fat in the left or downside half of the targeted scar and injected with normal saline in the right or upside half of the targeted scar.
Blinding (investigator's opinion)
Double blinded
Blinding description
The people listed below will be kept blind to the treated halves until the end of data collection:
Main researcher
The clinical investigator evaluates patients before the procedure and the Physicians who evaluate the outcomes
Clinical care providers after the procedure
Participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine, Iran University of Medical Sciences
Street address
21st St, Yousef Abad St, District 6, Tehran, Fatemeh Hospital
City
Tehran
Province
Tehran
Postal code
IR.IUMS.FMD.REC.1401
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.IUMS.FMD.REC.1401.485
Health conditions studied
1
Description of health condition studied
Scars
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
2
Description of health condition studied
Burn of head, face, and neck sequela
ICD-10 code
T20.00XS
ICD-10 code description
Burn of unspecified degree of head, face, and neck, unspecified site, sequela
3
Description of health condition studied
Burn of trunk sequela
ICD-10 code
T21.00XS
ICD-10 code description
Burn of unspecified degree of trunk, unspecified site, sequela
4
Description of health condition studied
Burn of limbs sequela
ICD-10 code
T22.00XS
ICD-10 code description
Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela
5
Description of health condition studied
Burn of Lower Limb sequela
ICD-10 code
T24.009S
ICD-10 code description
Burn of unspecified degree of unspecified site of unspecified lower limb, except ankle and foot, sequela
6
Description of health condition studied
hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Overall Scar Score (Observer)
Timepoint
Before intervention and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
2
Description
Overall Scar Score (Patient)
Timepoint
Before intervention and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
Secondary outcomes
1
Description
Scar Vascularity
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
2
Description
Scar Pigmentation (Observer Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
3
Description
Scar Thickness (Observer Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
4
Description
Scar Relief (Observer Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
5
Description
Scar Pliability (Observer Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
6
Description
Scar Surface Area
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
7
Description
Scar Pain
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
8
Description
Scar Itching
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
9
Description
Scar Color Difference (Patient Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
10
Description
Scar Stiffness (Patient Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
11
Description
Scar Thickness (Patient Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
12
Description
Scar Irregularity (Patient Score)
Timepoint
Before interventions and three months after intervention
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire
Intervention groups
1
Description
First, the subcision and release of adhesions in the subdermal area of the specified location for fat injection are performed with a standard blunt cannula with a diameter of 1.5 mm. Autologous fat is harvested by Coleman's standard technique (with a 10 ml syringe connected to a blunt cannula with a diameter of 3 having several side holes at the end with a diameter of 2 mm) from the abdomen or side or medial thigh and then separating the fat by transferring it through a standard connector. 3 mm disposable syringe to a 2.5 ml syringe and placed in a centrifuge for 3 minutes with a rotation rate of 1200 rpm, and then the oil collected on the syringes and the bloody liquid contained at the bottom Syringes are thrown away. A standard 3 mm disposable connector transfers the separated fat to a 1 ml syringe with a lower lock. And in the marked half of the scar, using this 1 ml syringe connected to a blunt cannula with a diameter of 0.7 ml with a hole (Spon Tip), fat injection is performed under the scar at the rate of 0.4 ml per square centimeter in the subdermal area.
Category
Treatment - Surgery
2
Description
Control group: First, subcision and release of adhesions of the semi-scarred subdermal area are performed for normal saline injection with a blunt standard cannula with a diameter of 1.5 mm. Then, normal saline injection with a volume equal to the injected fat is performed in the subdermal area using a 1 ml syringe connected to a blunt cannula with a diameter of 0.7 with a hole (Spoon Tip).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Fatemeh Faraji
Street address
21st St, Asad Abadi St, Tehran
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Web page address
https://crtfatima.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Motahhari Burn Hospital
Full name of responsible person
Alireza Shiri
Street address
Motahhari Burn Hospital, Yesmi St, Vali-Asr St, Tehran
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8877 0031
Fax
+98 21 8877 0048
Email
motahari.hos@iums.ac.ir
Web page address
https://crtm.iums.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
5th floor, Main Building, Iran university of medical sciences, Hemmat Exp way, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.hi@ums.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
Seyyed-ehsan Mousavi-lajimi
Position
Sub-speciality Resident
Latest degree
Specialist
Other areas of specialty/work
Plastic and Reconstructive Surgery
Street address
َApt 7, No 10, Abtahi St, Kordestan Exp, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1437633583
Phone
+98 21 8835 1450
Email
s.ehsan.mousavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed-Ehsan Mousavi-Lajimi
Position
Subspecialty Resident
Latest degree
Specialist
Other areas of specialty/work
Plastic and Reconstructive Surgery
Street address
َApt 7, No 10, 20th Kordestann Exp., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1437633583
Phone
+98 21 8835 1450
Fax
Email
s.ehsan.mousavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed-ehsan Mousavi-lajimi
Position
Sub-speciality Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
َApt 7, No 10, Abtahi St, Kordestan Exp, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1437633583
Phone
+98 21 8835 1450
Email
s.ehsan.mousavi@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