Fat Grafting in Upper Limb Burns Scars: a Randomized Clinical Trial
Phase: NA
Conditions: Autologous Fat Grafting, Burn, Corticosteroid Injection
Sponsor: Federal University of São Paulo

 
Informed Consent Form 
 
Date: 24/06/2025 
Title of the Research Project: 
Sequelae of upper limb burns, functional contractures, and pathological scars: a 
randomized clinical trial of fat grafting versus corticosteroid injection 
Principal Investigator: 
Alfredo Gragnani Filho 
Research Team: 
Alfredo Gragnani Filho and Marcelo Oliveira Mourão Junior 
Location: 
Hospital São Paulo – Discipline of Plastic Surgery – Burn Treatment Unit (UTQ) 
 
Invitation to Participate 
You are invited to voluntarily participate in the research project described above 
voluntarily. You are being asked because you are receiving care at the Burn Treatment 
Unit (UTQ) of the Plastic Surgery Discipline at Hospital São Paulo, affiliated with the 
Escola Paulista de Medicina – Universidade Federal de São Paulo (UNIFESP). Your 
participation is important, but you should not feel obligated. 
All information collected in this study will be confidential. Only the research team will 
have access to your identity, which will be kept anonymous. The data will be used 
solely for research purposes. At any time, before, during, or after the study, you may 
ask for further clarification, refuse to participate, or withdraw without any penalty or 
consequence. 
If you have questions, you may contact: 
Dr. Alfredo Gragnani Filho – Tel: +55 11 99658-4632 – Email: 
alfredo.gragnani@unifesp.br 
Dr. Marcelo Oliveira Mourão Junior – Tel: +55 11 99356-7651 – Email: 
marcelo.mourao@unifesp.br 
Participant Rights 
For more information about your rights as a research participant, you may access the 
booklet developed by the Brazilian National Research Ethics Commission (CONEP). 

 
This study has been reviewed and approved by a Research Ethics Committee (REC), 
which is responsible for overseeing the ethical aspects of human research. If you have 
questions about your rights or are dissatisfied with how the study is being conducted, 
you may contact: 
REC–UNIFESP 
Rua Sena Madureira, 1500 – 2nd floor – Vila Clementino – São Paulo, SP – Brazil – 
ZIP: 04021-001 
Email: cep@unifesp.br – Tel: +55 11 3385-4343, extensions 8699 / 8557 
Office hours: Monday to Friday, 8:00 AM to 1:00 PM 
 
Study Information 
Justification 
Burn injuries represent a major public health issue, often leading to physical and 
psychological sequelae, work absence, and reduced quality of life. When upper limbs 
(hands, forearms, elbows, arms, shoulders) are affected, and complications such as 
contractures or pathological scars occur, the impact can be especially severe. This study 
aims to investigate and compare two treatment strategies: 
• 
Control Group: corticosteroid injections (triacinolone) 
• 
Experimental Group: autologous fat grafting (lipofilling) 
Participants will be randomly assigned to one of the two groups and followed for 6 
months. If the fat grafting proves more effective, this option will be offered to the 
control group participants at no cost. 
Study Objectives 
To compare fat grafting (experimental group) versus corticosteroid injection (control 
group) in the treatment of post-burn sequelae of the upper limbs. 
Target Population 
Burn victims with functional sequelae and/or pathological scars on the upper limbs. 
Procedures 
Volunteers will be randomly assigned to one of two groups: 
• 
Experimental Group: autologous fat grafting 
• 
Control Group: corticosteroid injection 
Participants will remain in their assigned group throughout the 6-month evaluation 
period. 
 

 
 
Risks of Participation 
 
Fat Grafting Group: 
As a surgical procedure, risks may include bleeding, seroma, infection, need for 
reoperation, or wound dehiscence. All necessary precautions will be taken before, 
during, and after the procedure to minimize risks. 
Corticosteroid Group: 
Risks may include pain at the injection site, allergic reactions, infection, excessive skin 
retraction or discoloration. Standard safety measures will be followed to ensure a safe 
procedure. 
In the event of any adverse event, medical care and follow-up will be provided free of 
charge. If a causal relationship with the study is established, participants may be entitled 
to legal compensation. 
If any clinical or emotional condition is identified during the study (e.g., emotional 
distress), the research team will offer appropriate guidance and referrals to public 
healthcare services. 
All transportation and food expenses related to participation will be covered by the 
research team. There will be no costs to the participant. 
 
Benefits of Participation 
Fat grafting has shown positive effects on scar quality, skin elasticity, range of motion, 
and reduction of pain and itching. Participants will receive treatment at no cost and 
continuous follow-up by the research team. Indirect benefits include advancing 
scientific knowledge in burn care. 
Privacy and Confidentiality 
All personal data will be protected. No identifying information will be published. Study 
results may be shared or published, but always anonymously. 
Access to Results 
Participants may request access to partial or final study results. 
Costs and Compensation 
There are no costs or financial compensation involved. All study-related expenses (e.g., 
transport, food) will be covered by the research budget. 
 
 

 
Consent Statement 
I, the undersigned, voluntarily agree to participate in this research study. I have been 
fully informed about the study objectives, procedures, risks, and potential benefits. I 
understand that I can withdraw at any time without penalty. I authorize the use of my 
data for research purposes under confidentiality. I received a copy of this signed and 
initialed consent form. 
 
Participant Name: ___________________________________________ 
Signature: _________________________________________________ 
Location and Date: _________________________________________ 
 
Declaration of the Investigator 
 
I, the undersigned, declare that I will ensure the confidentiality and secure storage of all 
participant data. I confirm that I have explained the study details and answered all 
participant questions. 
 
Principal Investigator: Alfredo Gragnani Filho 
Signature: ___________________________ Date: ____________ 
 
Co-investigator/Witness: Marcelo Oliveira Mourão Junior 
Signature: ___________________________ Date: ____________