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Comparing the Effect of Platelet Rich Fibrin Injection with Microneedling Versus Normal Saline Injection with Microneedling in the Treatment of Atrophic Burn Scars: A Randomized Clinical Trial

Protocol summary

Study aim
Comparison of the Effect of Platelet-Rich Fibrin Injection and Microneedling versus Microneedling Alone in the Treatment of Atrophic Scars Resulting from Burns.
Design
Phase 3, two-arm, parallel group, double-blind, randomized trial involving 21 patients. Randomization is achieved using balanced block randomization.
Settings and conduct
Place of study: Rasool Akram Hospital; Study population: 26 patients with bilateral atrophic burn scars; Type of blinding: patient and evaluator; Method of blinding: request patients to close their eyes during injections and not informing the evaluator of the scars` grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people aged 18-60; The presence of bilateral burns. Exclusion criteria: patients with underlying disease disrupting collagen synthesis, blood coagulation disorders and immunocompromised patients; Pregnant patients or those who intend to become pregnant; Patients with any type of malignancy; heavy smokers; Patients who have undergone scar treatment in the 3 months leading up to the start of the study; Patients who are mentally incapable of giving consent to participate in the study.
Intervention groups
Intervention Group: Injection of Platelet-Rich Fibrin along with Microneedling. Control Group: Injection of Normal Saline along with Microneedling.
Main outcome variables
Changes in the Patient and Observer Scar Assessment Scale (POSAS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231209060308N1
Registration date: 2024-01-12, 1402/10/22
Registration timing: prospective

Last update: 2024-01-12, 1402/10/22
Update count: 0
Registration date
2024-01-12, 1402/10/22
Registrant information
Name
Farzan Moodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 7501
Email address
dr.farzanmoodi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Platelet Rich Fibrin Injection with Microneedling Versus Normal Saline Injection with Microneedling in the Treatment of Atrophic Burn Scars: A Randomized Clinical Trial
Public title
Effect of Platelet Injection on Burn Scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of at least two atrophic burn scars anywhere on the body in a symmetrical pattern. Age between 18-60 years. Both male and female genders are included in this study.
Exclusion criteria:
Patients with underlying conditions such as diabetes, blood clotting disorders, and immunodeficiency disorders. Pregnant patients or those planning to become pregnant. Patients diagnosed with any malignancy. Smokers with more than one pack of cigarettes per day (Heavy Smokers) Patients who have received another treatment for their scars within the 3-month period prior to the commencement of the intervention, which may have led to collagen stimulation. Patients who do not have the mental capacity to provide consent for participation in the study or to respond to researchers' inquiries.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 21
More than 1 sample in each individual
Number of samples in each individual: 2
Including both sides of the face, both sides of the chin, and the upper neck in cases not connected to facial burns, as well as the back of the hands up to the wrists. It should be noted that not all individuals have all these types of burns.
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization in this study, the block balanced randomization method will be utilized. Accordingly, we prepare packets for the number of patients, and within each packet, we allocate the treatment and control arms alternately to the right and left side of the face. For instance, in the first packet, the treatment arm for the right hand scar and the control arm for the left hand scar, and in the next packet, this arrangement will be reversed. To ensure that only the evaluator is aware of the arms, abbreviated symbols such as A and B will be used on each paper. Then, when the patient visits, they will be asked to choose one of the packets, and based on their selection, the treatment and control arms will be determined. Thus, at the end of the study, each body part in half of the patients will be in the treatment arm, and in the other half, it will be in the control arm.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical Caregiver and Evaluator Blinding: In this study, the role of the clinical caregiver and evaluator is assigned to one person, who also serves as the primary physician of the patient. For blinding, no information related to the treatment and control arms is provided during any of the initial assessment stages and follow-up sessions, which occur one month and three months after the treatment. The physician is required to evaluate the patient's scar without knowledge of these two arms. Participant Blinding: To blind the participants regarding the treatment and control arms, normal saline solution is injected instead of PRF in the control arm. Due to the color difference between these two substances (PRF and normal saline), patients are requested to close their eyes for greater comfort during the injection process. With this method, the patient will not be aware of the color difference between the two injected substances.
Placebo
Used
Assignment
Parallel
Other design features
Due to the necessity of ensuring that patients are not deprived of effective scar treatment, all scars will undergo standard treatment involving collagen stimulation with microneedling. Microneedling will be performed using Dermapen, which has disposable needles at the end. The length of these needles will be set at 1.5-2 millimeters, and the device speed will be set to high speed. The device will be moved perpendicular to the scar, covering the entire scar, to induce pinpoint bleeding.For the preparation of Injectable PRF, the standard centrifugation method introduced by Miron et al. will be employed. Blood will be centrifuged for 3 minutes at a gravitational acceleration of 60. Depending on the physician's judgment and the extent of the scar, the desired volume of PRF will be obtained by drawing blood from the patient at a rate of two and a half times the desired PRF volume. Subsequently, the patient's collected blood will be evenly divided into two test tubes and placed in the centrifuge device in a symmetrical arrangement. Following the device settings protocol with gravitational acceleration (g) set at 60, and the number of revolutions per minute (rpm) variable depending on the device, centrifugation will be performed for 3 minutes. The resulting composition will include blood cells at the bottom of the tube and PRF at the top. The separated PRF will then be injected intradermally into the scar on the treatment arm before coagulation.Additionally, normal saline solution will be used for injection into the control arm to blind the patient. Since there is no study proving the effect of normal saline in the collagen synthesis process and similar use in other studies, it is considered a suitable substance for patient blinding.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Directorate of Health, Rescue and Treatment of Police Headquarter of I
Street address
Health, Relief, and Treatment Deputy of NAJA, Edward Brown Street, North Karegar Street, Enqelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۴۴۶۶۱
Approval date
2023-12-09, 1402/09/18
Ethics committee reference number
IR.SBMU.TEB.POLICE.REC.1402.076

Health conditions studied

1

Description of health condition studied
Burn scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin

Primary outcomes

1

Description
Patient and Observer Scar Assessment Scale (POSAS) points
Timepoint
In the first visit, the initial treatment session, one month, and three months after the last treatment session.
Method of measurement
Patient and Observer Scar Assessment Scale (POSAS)

2

Description
Changes in skin tone evenness
Timepoint
In the initial treatment session, one month, and three months after the last treatment session.
Method of measurement
VisioFace

3

Description
Local inflammatory or irritating adverse events
Timepoint
Within two weeks after each treatment session
Method of measurement
Patient visit or report

4

Description
Hemosiderin staining
Timepoint
Within two weeks after each treatment session
Method of measurement
Patient visit or report

5

Description
Herpes
Timepoint
Within two weeks after each treatment session
Method of measurement
Patient visit or report

6

Description
Hypersensitivity reactions
Timepoint
Within two weeks after each treatment session
Method of measurement
Patient visit or report

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Receiving microneedling along with injection of normal saline.
Category
Placebo

2

Description
Intervention group: Receiving microneedling along with injection of platelet-rich fibrin into the specific scar area on the treatment arm, derived from the patient's blood processed in a centrifuge set on 60G.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Specialized Educational and Medical Center
Full name of responsible person
Farzan Moodi
Street address
Hazrat Fatemeh Specialized Educational and Medical Center; Next to Shafaq Park; 21st Street; Asadabadi Street; Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
crtfatima@iums.ac.ir
Web page address
https://crtfatima.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Mousavizadeh
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
farzan.cod@gmail.com
Web page address
https://iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Center for Applied Research, Deputy of Health, Relief, and Treatment, NAJA
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzan Moodi
Position
General Physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit 3, No. 14, 33rd street, Gisha
City
Tehran
Province
Tehran
Postal code
1447934161
Phone
+98 21 8601 7501
Email
dr.farzanmoodi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzan Moodi
Position
General Physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit 3, No. 14, 33rd street, Gisha
City
Tehran
Province
Tehran
Postal code
1447934161
Phone
+98 915 771 7179
Email
dr.farzanmoodi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzan Moodi
Position
General Physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Unit 3, No. 14, 33rd street, Gisha
City
Tehran
Province
Tehran
Postal code
1447934161
Phone
+98 21 8601 7501
Email
dr.farzanmoodi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Non-identifiable patient data will be made available after analysis in the article extracted from the accessible study. These include demographic data and changes in variables related to patients' burn scar.
When the data will become available and for how long
Immediately after the publication of the article.
To whom data/document is available
Aggregate data will be accessible for all individuals. Individual data, upon request, will be provided by the corresponding author.
Under which criteria data/document could be used
All investigations leading to the improvement of the research project's outcomes and the advancement of burn scar treatment are feasible.
From where data/document is obtainable
Email should be sent to the corresponding author in the article.
What processes are involved for a request to access data/document
The requester should introduce themselves, specify the type of data requested, provide the reason for the request, and outline the investigations they would like to conduct in their message.
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