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

Title: Upper Limb Burns Sequelae, Functional Contractures and Pathological Scars: a 
Randomized Clinical Trial of Fat Grafting Versus Corticosteroid Injection. 
Trial Registration:  
Date of registration: 08/25/2025. 
WHO UTN code: U1111-1325-8730\ 
Protocol version: first version. 
 
Authors: Marcelo Oliveira Mourão Junior. Alfredo Gragnani Filho. 
Funding: The authors have no conflicts of interest to declare. There was no funding. 
 
Abstract 
 
Burns are a complex form of trauma with a high risk of complications. Involvement of 
the upper limbs frequently results in significant sequelae that negatively affect patients’ 
quality of life, functional capacity, and psychological well-being. Traditionally, these 
cases are managed with surgical interventions and/or corticosteroid injections into 
lesions and scars. However, these treatments are only moderately effective, require 
prolonged therapeutic courses, and carry potential risks. They also present limitations 
in promoting true tissue regeneration and scar quality improvement. Furthermore, 
corticosteroid therapy often requires multiple injections, which can be painful, result in 
substantial time away from work, and generate high indirect costs. 
 
Autologous fat grafting (lipofilling) has emerged as a promising therapeutic alternative 
within the field of regenerative medicine. As a biocompatible and autologous tissue, fat 
grafts are not associated with immunogenic risk and may exert regenerative effects 
through cellular and paracrine mechanisms. This may lead to both functional and 
aesthetic benefits. 
 
This randomized clinical trial will include patients with upper limb burn sequelae—
functional impairments and/or pathological scars—who will undergo either autologous 
fat grafting or standard corticosteroid-based treatment. All participants will be followed 
prospectively and assessed using validated scar and function assessment tools. 
 
Given the current gaps in the literature and the lack of high-quality comparative studies 
on this topic, the primary objective of this study is to evaluate the efficacy of autologous 
fat grafting for the treatment of upper limb burn sequelae, in comparison to standard 
care. 
 
Key words: Burn; Transplantation; Regenerative Medicine. 
 
 
 
 

Introdução 
 
Burn injuries are among the most complex forms of trauma and, when not resulting in 
death, are frequently associated with disabling physical and psychological 
consequences, leading to significant deterioration in quality of life for both patients and 
their families. 
 
Burn trauma is widely recognized as a major public health problem (1,2,3). 
Understanding its epidemiology and etiological factors is essential for both the planning 
of preventive strategies and the development of effective treatment protocols (4). 
According to data from the World Health Organization (WHO), 111,196 deaths due to 
burns occurred worldwide in 2019, with approximately 90% of these deaths occurring 
in low- and middle-income countries (5). 
 
In Brazil, data from the Ministry of Health (2015–2020) reported 19,772 burn-related 
deaths during that period. Of these, 53.3% were attributed to thermal burns, 46.1% to 
electrical burns, and 0.6% to other causes such as chemical, cold, or radiation burns. 
Thermal burns are most commonly sustained in the home, a trend that worsened during 
the COVID-19 pandemic. Notably, most fatalities caused by electrical trauma (70.1%) 
occurred outside healthcare facilities, due to the severity of the injuries at the site of the 
incident. Electrical burns are also frequently associated with major amputations, 
representing a leading cause of years of life lost and long-term work disability (6). 
 
Burn injuries present a broad clinical spectrum and often result in long-term morbidity, 
impacting emotional and physical well-being as well as quality of life. Beyond the 
immediate acute management, these patients typically require prolonged rehabilitation 
due to frequent development of chronic and disabling complications. For this reason, 
burns are considered a high-cost public health burden with significant socioeconomic 
impact (5,6). 
 
The most common burn sequelae include physical complications such as scars, 
contractures, chronic pain, and pruritus, as well as psychological effects such as 
insomnia, anxiety, depression, and post-traumatic stress disorder (7,8). In particular, 
upper limb involvement often leads to pathological scarring, retraction, and reduced 

joint mobility, significantly impairing function and quality of life (9,10). The optimal 
approach to the rehabilitation of such patients remains under debate in the literature 
(10,11,12). 
 
Autologous fat grafting (lipofilling), a technique involving the injection of processed 
adipose tissue, has emerged as a promising alternative for the treatment of hypertrophic 
scars and contractures resulting from burns. It offers not only aesthetic and contour 
improvements but also restoration of skin elasticity and joint function (13). Several 
mechanisms have been proposed to explain its beneficial effects, including the presence 
of mesenchymal stem cells and growth factors in the grafted adipose tissue, modulation 
of local inflammatory responses, reduction of oxidative stress, and promotion of tissue 
regeneration (14,15,16). Furthermore, fat grafting has proven to be a safe procedure 
with low complication rates, particularly because it uses autologous tissue and is 
therefore non-immunogenic (17,18). 
 
In burn sequelae, fat grafting contributes to extracellular matrix remodeling and 
neovascularization of the scarred areas, leading to superior functional outcomes 
compared to conventional scar release techniques alone (15,16). Specifically in the 
upper limbs, its effect on scar contracture may significantly improve range of motion 
and functionality by attenuating dermal fibrosis, balancing collagen deposition, and 
reducing skin stiffness (14,15). After grafting, cellular differentiation and trophic factor 
secretion further contribute to skin and soft tissue regeneration, resulting in more 
pliable scars with reduced risk of retraction (19). Recent evidence also suggests that fat 
grafting can significantly reduce neuropathic pain associated with burn scars, thereby 
improving overall quality of life (20,21). 
 
The use of autologous fat grafting in upper limb burn sequelae represents a meaningful 
advancement in reconstructive surgery. Increasingly, fat grafting is being adopted to 
treat contour and volume defects in various clinical contexts, including 
fibroproliferative scars following burns (22). Clinical benefits in this patient population 
include improved skin texture and elasticity, pain reduction in hypertrophic scars, and 
enhanced functional recovery of affected limbs. Although challenges such as variability 
in fat graft resorption remain, current literature supports its consideration as a 
therapeutic option, especially for patients with severe post-burn scarring (20,21,23). 

 
Primary Objective: 
To evaluate the efficacy of autologous fat grafting in the treatment of burn sequelae and 
pathological scars of the upper limbs, in comparison with the standard treatment using 
corticosteroid injections. 
 
Secondary Objectives: 
• To assess aesthetic and structural changes through standardized photographic 
analysis. 
• To evaluate the quality of life of burn patients undergoing each treatment modality. 
 
Methods 
 
Trial Design 
This is a single-center, randomized controlled trial (RCT) designed in accordance with 
the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the 
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). The 
study will be conducted at the Federal University of São Paulo (Universidade Federal 
de São Paulo – UNIFESP), using a stratified randomization design (age 18–50 years) 
and a 1:1 allocation ratio. Participants will be randomly assigned to one of two parallel 
arms (autologous fat grafting vs corticosteroid injection). The study will be single-
blinded, with outcome assessors blinded to treatment allocation. All participants will 
provide written informed consent prior to enrollment, in compliance with ethical 
regulations and after approval by the UNIFESP Research Ethics Committee. 
 
Sample Size 
A total of 40 participants will be enrolled from the outpatient clinics of the Burn Unit 
and the Pathological Scars Unit at the Plastic Surgery Division of UNIFESP. 
 
Inclusion Criteria 
• 
Adults ≥18 years of age of any sex. 
• 
Burn injury involving the upper limb (hand, elbow, and/or axilla) occurring 
more than 12 months prior to screening. 
• 
Presence of functional sequelae and/or pathological scarring. 

• 
No ongoing treatment or history of any scar-related intervention within the past 
6 months. 
 
Exclusion Criteria 
• 
Patients under 18 years of age. 
• 
Presence of severe or debilitating systemic conditions contraindicating the 
proposed intervention or posing high surgical risk. 
• 
Receipt of any surgical or medical treatment in the target area within 6 months 
prior to enrollment. 
 
Withdrawal Criteria 
Participants who fail to complete any stage of the study protocol will be withdrawn 
from the trial. Voluntary withdrawal from participation will be accepted at any time 
without compromising access to ongoing clinical care or follow-up. 
 
Study Workflow 
All participants will undergo an initial clinical evaluation including history-taking and 
physical examination to characterize burn sequelae and scar quality. Baseline 
assessment will include the application of validated scar questionnaires and 
standardized photographic documentation. 
 
Participants will then be randomized into two groups: 
• 
Experimental Group (EG): Autologous fat grafting (single session), with fat 
harvested from the lower abdomen. 
• 
Control Group (CG): Single session of corticosteroid infiltration using 
triancinolone 20mg/mL. 
 
Clinical Assessment 
Clinical evaluation will include structured anamnesis, physical examination, and 
characterization of the scar area. Symptoms such as pain and pruritus will be scored 
using a Visual Analog Scale (VAS) ranging from 0 (no symptom) to 10 (maximum 
intensity). Erythema will be assessed through visual inspection and finger-press 
blanching for 3 seconds followed by capillary refill observation. 
 

Validated Instruments and Follow-up 
Three validated scar assessment tools will be used, administered at baseline, and at 3 
and 6 months of follow-up: 
1. POSAS (Patient and Observer Scar Assessment Scale): Developed by 
Draaijers (2003) and adapted by Lenzi (2019). It includes two 6-item scales 
(patient and observer), each scored from 1 (normal skin) to 10 (worst 
imaginable scar characteristic). Total scores range from 6 to 60; lower scores 
indicate better outcomes. 
2. Vancouver Scar Scale (VSS): Developed by Sullivan et al. (1990), adapted to 
Brazilian Portuguese by Santos (2014). Evaluates four scar attributes: 
pigmentation, vascularity, pliability, and height. Total scores range from 0 to 
13, with lower scores reflecting more favorable scar quality. 
3. PSAQ (Patient Scar Assessment Questionnaire): Developed by Durani 
(2009), translated and culturally adapted by Ota (2017). Contains 39 items 
divided into two components: scar attributes (appearance, symptoms, texture) 
and patient satisfaction (appearance and symptoms). Responses range from 
“very satisfied” to “very dissatisfied.” 
 
Photographic Documentation 
Standardized photographs will be taken at baseline, and at 1, 2, 3, and 6 months using 
the same camera and positioning protocol. Images will include frontal, lateral, and 
oblique bilateral views against a uniform blue background. A fixed floor marker will 
guide patient foot placement to ensure reproducibility. Patients will stand upright with 
gaze fixed on the horizon. 
 
Randomization Process 
Participants will be randomized into blocks of four using a randomization list generated 
through the Sealed Envelope platform (https://www.sealedenvelope.com). Allocation 
will occur after completion of baseline assessment. A schematic figure (Figure 1) will 
illustrate the pre-intervention flow of procedures. 
  

 
 
Figure 1: Study Flow Diagram 
 
For all participants, a standardized treatment area of 10 cm² will be defined and 
demarcated within the scarred region. This delimited area will be used for both 
the intervention and subsequent clinical and photographic assessments, ensuring 
consistency and comparability across patients. 
 
Adipose Tissue Harvesting Procedure (Fat Graft Collection) 
 
Participants allocated to the fat grafting group will undergo the procedure in a 
dedicated surgical room at the Plastic Surgery Division of the Federal University of São 
Paulo (UNIFESP). Upon arrival, patients will have their vital signs, heart rate, and 
blood pressure checked by the nursing staff. 
While in the supine position on a surgical stretcher, patients will receive local 
anesthesia at two sites: 
1. The region surrounding the target scar on the thorax 
2. The lower abdomen (donor area for fat harvest) 
Pacientes 
incluídos 
(n=40)
Anamnese
Exame Físico
POSAS
VSS
PSAQ
Fotografia
Randomização
Grupo Experimental 
- Lipoenxertia (n=20)
Grupo Controle -
Corticosteroide 
(n=20)

The anesthetic solution will consist of 2% lidocaine, 0.9% normal saline, and 
epinephrine at a final concentration of 1:100,000 to promote vasoconstriction. 
 
Fat harvesting will be performed through a single transverse incision located at the 
midline of the lower abdomen, approximately 7 cm above the vaginal introitus or penile 
base. The subcutaneous area accessed will represent a semicircular segment. The 
incision will be approximately 2.5 mm in length to accommodate the introduction of a 
3.0 mm diameter, 15 cm long blunt-tip cannula connected to a 10 mL syringe for low-
pressure manual aspiration. 
 
Fat Graft Injection Technique (Lipofilling) 
 
The harvested fat will undergo gravity-based decantation for 10 minutes directly within 
the syringe, without environmental exposure. The liquid fraction will be discarded, and 
the remaining purified fat will be used for injection. The required volume will be 
estimated at 0.5 mL per square centimeter of scar tissue. 
The fat will be injected using a 1.7 mm diameter, 5 cm long blunt cannula connected to 
a 1 mL Luer Lock syringe. The graft will be delivered into the subcutaneous plane 
beneath the scar, using a retrograde injection technique, parallel to the skin. Multiple 
intersecting and overlapping tunnels will be created through two perilesional micro-
incisions (approximately 2 mm in length), oriented along the horizontal and vertical 
axes of the scar (Figure 2). 
 

Figure 2: Schematic Representation of Lipofilling Technique 
 
The black dot represents the incision site used for fat injection along the vertical 
axis of the scar, while the red dot marks the incision site along the horizontal axis. Black 
arrows indicate the direction of fat injection tunnels in the vertical subcutaneous plane, 
and red arrows represent the horizontal vectors. The schematic demonstrates the 
creation of a crisscross meshwork of injection tunnels covering the entire scar area. 
 
Postoperative Care (Fat Grafting Group) 
 
After the fat grafting procedure, an occlusive dressing will be applied over the 
treated scar and secured with microporous adhesive tape. The dressing will remain in 
place for 24 hours, after which it will be replaced with a similar dressing for an 
additional 24 hours. Further dressing changes will be performed as needed based on 
clinical assessment. The experimental group (EG) will undergo only one fat grafting 
session. 
 
Donor Site Management 
 

The 2.5 mm incision used for fat harvesting will be closed using primary suture 
with 5-0 nylon, followed by a simple dressing with sterile gauze and microporous tape. 
 
Corticosteroid Infiltration Technique (Control Group) 
 
Patients in the control group will undergo intralesional injection of triamcinolone 
acetonide at a concentration of 40 mg/mL. The corticosteroid will be distributed at a 
dose of 10 mg per linear centimeter of scar tissue, with a maximum total dose of 100 
mg per session in the predetermined 10 cm2 area. 
Injections will follow a radial pattern, beginning at the margins and progressing 
toward the center of the scar. A retrograde injection technique will be used. All 
infiltrations will be performed under local anesthesia, using a subcutaneous field block 
with 2% lidocaine containing epinephrine (Figure 3). 
 
Figure 3: Radial Pattern of Corticosteroid Injection 
The arrows indicate the radial injection pattern of corticosteroid infiltration, 
surrounding and covering the entire scar area. 
 
Follow-Up and Periodic Evaluation 
Participants in both groups will undergo scheduled follow-up assessments at 1, 3, and 

6 months post-intervention. At each follow-up visit, standardized photographic 
documentation of the treated scar and the patient will be performed. 
Two board-certified plastic surgeons with a minimum of 5 years of experience will 
independently evaluate the photographs in a blinded fashion, without knowledge of the 
participant’s group allocation. 
Each evaluation will include assessment of the following scar characteristics: 
• 
Overall appearance 
• 
Color and pigmentation 
• 
Vascularity 
• 
Height of the scar or keloid 
• 
Global aesthetic improvement 
 
All participants will be monitored for adverse events throughout the study period, 
including the perioperative phase and at each follow-up visit (1, 3, and 6 months). Any 
clinical complications such as infection, fat necrosis, contour irregularities, delayed 
wound healing, allergic reactions, or systemic effects will be documented and managed 
according to standard institutional protocols. All events will be classified by severity 
(mild, moderate, severe) and causality (related or unrelated to the intervention), 
following international clinical trial guidelines. 
 
Serious adverse events (SAEs) will be immediately reported to the institutional 
Research Ethics Committee (REC/CEP) and recorded in the study database. 
Participants experiencing any complication will receive appropriate medical care and 
will not be withdrawn unless they or the research team deem it necessary. A Data and 
Safety Monitoring Plan (DSMP) has been outlined, and safety outcomes will be 
reviewed periodically by the principal investigator to ensure compliance with ethical 
and safety standards. 
 
 
Outcomes 
 
Primary Outcome Measure 
 
Outcome Title: 

Improvement in Scar Quality (Patient and Observer Scar Assessment Scale – POSAS) 
 
Description: 
The primary outcome is the change in scar quality in the upper limbs from baseline to 
6 months post-treatment, assessed using a validated instrument: the Patient and 
Observer Scar Assessment Scale (POSAS). The POSAS includes both patient-reported 
and clinician-observed domains, each comprising six items scored from 1 (normal skin) 
to 10 (worst imaginable scar characteristic). Total scores range from 6 (best possible 
scar) to 60 (worst possible scar). Lower scores indicate better scar quality. 
 
Time Frame: 
6 months after intervention 
 
Secondary Outcome Measures 
 
1. Outcome Title: Patient Satisfaction with Treatment 
 
Description: Subjective satisfaction with the aesthetic and functional outcomes of 
treatment, measured using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 
(very satisfied). 
 
Time Frame: 6 months after intervention 
 
2. Outcome Title: Need for Additional Interventions 
 
Description: Number and type of additional procedures required during the follow-up 
period, including surgical re-interventions, repeat corticosteroid injections, or 
secondary fat grafting. 
 
Time Frame: 6 months after intervention 
 
3. Outcome Title: Incidence of Adverse Events 
 
Description: Occurrence of treatment-related adverse events, including fat necrosis, 

infection, contour irregularities, delayed wound healing, or systemic complications. 
Events will be assessed clinically at follow-up visits. 
 
Time Frame: 1 week, 1 month, and 6 months after intervention 
 
4. Outcome Title: Scar Improvement Measured by Vancouver Scar Scale (VSS) and 
Patient Scar Assessment Questionnaire (PSAQ) 
 
Description: 
Changes in scar characteristics and symptoms (e.g., pain, pruritus, stiffness) as 
measured by two additional validated instruments: 
– Vancouver Scar Scale (VSS): Evaluates pigmentation, vascularity, pliability, and 
height (range: 0–13; lower is better). 
– Patient Scar Assessment Questionnaire (PSAQ): Assesses both physical attributes 
and patient satisfaction. 
These scales will be administered at baseline and 6 months post-intervention. 
 
Time Frame: 6 months after intervention 
 
 
Statistical Analisys 
 
Following data collection, descriptive statistics will be performed and relative 
frequency distributions will be compared using the two-proportion z-test. Pearson’s 
correlation coefficient will be calculated to assess the relationship between quantitative 
variables. 
For group comparisons: 
• 
Categorical variables will be analyzed using the Chi-square test. 
• 
Continuous variables will be compared using the paired Student’s t-test when 
appropriate. 
• 
For non-normally distributed data, a nonparametric test equivalent to the 
Wilcoxon signed-rank test will be applied. 
 
A significance level of 0.05 will be adopted for all analyses, with 95% confidence 

intervals reported. 
All statistical analyses will be performed using SPSS® version 20, Minitab® version 
16, and Microsoft Excel® (Office Suite). 
 
All statistical analyses will follow the intention-to-treat (ITT) principle, meaning that 
all randomized participants will be analyzed within the group to which they were 
originally allocated, regardless of adherence to the intervention or protocol deviations. 
This approach ensures the preservation of randomization benefits and minimizes 
potential biases, particularly in the assessment of treatment effectiveness. 
 
 
 
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