Autologous Fat Grafting in Upper Limb Burns Scars (BURNSCARCARE)

September 15, 2025 updated by: Marcelo Oliveira Mourão Junior, Federal University of São Paulo

Fat Grafting in Upper Limb Burns Scars: a Randomized Clinical Trial

Burn injuries are a complex form of trauma with a high risk of complications. When they affect the upper limbs, patients often develop functional contractures and/or pathological scars that significantly impair mobility, quality of life, and psychological well-being. Current treatments-such as surgical interventions and corticosteroid injections-offer limited effectiveness, require prolonged therapy, and are associated with discomfort, multiple sessions, and indirect costs. Autologous fat grafting, a regenerative technique based on the transfer of the patient's own adipose tissue, has emerged as a promising alternative. It combines biocompatibility with regenerative and anti-inflammatory properties that may improve both function and scar quality. This randomized clinical trial aims to evaluate the efficacy of fat grafting in patients with post-burn upper limb sequelae compared to standard treatment (surgical release and/or corticosteroid injections). Patients will be prospectively followed and assessed using validated scar scales and functional outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Burns represent a serious public health issue and are among the leading causes of trauma-related morbidity worldwide. Involvement of the upper limbs frequently results in long-term complications, including functional contractures and pathological scars, which compromise the patient's ability to return to daily activities and may severely affect quality of life. Traditionally, these sequelae are managed using surgical scar release procedures and/or corticosteroid injections. However, these conventional approaches have limitations: they provide only moderate efficacy, often require repeated sessions, and do not directly stimulate tissue regeneration. Furthermore, corticosteroid injections are associated with discomfort and risk of skin atrophy, and their repeated application can generate significant treatment fatigue.

Autologous fat grafting has gained attention in the context of regenerative medicine due to its dual ability to restore volume and promote cellular repair. The technique consists of harvesting adipose tissue from a donor area, processing it to concentrate regenerative elements (such as adipose-derived stem cells and growth factors), and injecting it into the target area. In the context of burn sequelae, fat grafting has demonstrated promising results in improving scar pliability, reducing pain and pruritus, and enhancing function, although high-quality randomized clinical trials remain scarce.

This study will enroll adult patients with a history of upper limb burns presenting with functional limitations and/or symptomatic pathological scars (e.g., hypertrophic scars, painful or pruritic areas). Participants will be randomly assigned to one of two treatment groups:

Experimental Group: Undergoing autologous fat grafting in the affected areas. Control Group: Receiving standard treatment, including corticosteroid injections and/or surgical scar release based on clinical indication.

Patients will be followed prospectively at predetermined time points and assessed using validated tools such as the Patient and Observer Scar Assessment Scale (POSAS), the Patient Scar Assessment Scale (PSAQ) and the Vancouver Scar Scale (VSS). Pain and pruritus intensity will be documented using visual analog scales (VAS). The study's primary endpoint will be the improvement in scar quality and function at 6 months. Secondary outcomes include patient satisfaction, pain reduction, cost-effectiveness, and the need for additional interventions.

The study complies with ethical standards, and all participants will provide informed consent. Given the limited availability of randomized trials in this field, the results of this study are expected to contribute robust scientific evidence to support or refute the use of fat grafting as a therapeutic modality for upper limb burn sequelae.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04040030
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Presence of burn scars in the upper limbs (functional contractures and/or pathological scars)
  • Scar area suitable for treatment (≥10 cm²)
  • At least 12 months since the initial burn injury
  • Willingness and ability to comply with study procedures and follow-up visits
  • Signed informed consent form

Exclusion Criteria:

  • Active local or systemic infection at the time of treatment
  • Uncontrolled chronic diseases (e.g., diabetes mellitus with HbA1c > 8.0%)
  • Use of systemic corticosteroids or immunosuppressants within 30 days before enrollment
  • Previous surgical or injection treatment of the target scar within the past 6 months
  • Known allergy to lidocaine or any material used in the procedures
  • Coagulopathy or use of anticoagulant therapy
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group - Fat Graft
Participants randomized to this group will undergo autologous fat grafting to the affected areas of the upper limbs. The procedure includes harvesting adipose tissue via liposuction (typically from the abdomen or flanks), processing the fat through decantation and gentle emulsification, and reinjecting it into the burn sequelae areas using microcannulas in a layered, fanning technique. The intervention is performed in a single session under local or regional anesthesia depending on the case.
Procedure: Fat Graft
Non-regenerative standard treatment for post-burn sequelae, involving either corticosteroid injection to reduce scar inflammation and fibrosis, or surgical release for contractures. The procedure type will be chosen based on the clinical indication and severity.
Active Comparator: Control Group - Corticosteroid Injection
Participants in this group will receive standard care for burn scar sequelae, based on clinical judgment. This includes corticosteroid injections (triamcinolone 40 mg) for hypertrophic scars. The choice of intervention will follow standard clinical practice and will be documented in the protocol.
Procedure: Fat Graft
Non-regenerative standard treatment for post-burn sequelae, involving either corticosteroid injection to reduce scar inflammation and fibrosis, or surgical release for contractures. The procedure type will be chosen based on the clinical indication and severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 6 months after intervention

The primary outcome is the change in scar quality in upper limb from baseline to 6 months post-treatment, as measured by a validated instruments:

The Patient and Observer Scar Assessment Scale (POSAS), including both patient and observer domains (each scored 1-10, lower is better min: 6 points and maximum 60 points). Higher scores indicate worse scarring.
6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Additional Interventions
Time Frame: 6 month
Number and type of additional procedures (e.g., re-injection, new surgical release, corticosteroid reapplication) required during the follow-up period.
6 month
Incidence of Adverse Events
Time Frame: 1 week, 1 month and 6 month
Occurrence of treatment-related complications such as fat necrosis, infection, contour irregularities, delayed healing, or systemic adverse events.
1 week, 1 month and 6 month
Scar improvment measure by other scales - Patient Scar Assessment Scale
Time Frame: 6 month
Measured in days from intervention to return to pre-injury activity level or occupational function. Reduction in pain and itching symptoms associated with burn scars, measured using and Patient Scar Assessment Scale (PSAQ). Scores vary depending on the version and domains used (e.g., appearance, symptoms, consciousness, satisfaction with appearance, satisfaction with symptoms). Each item is rated on a 4-point scale, and composite scores are calculated for each domain. Higher scores indicate worse patient-perceived scar quality and lower satisfaction.
6 month
Scar improvment measure by other scales - Vancouver Scar Scale
Time Frame: 6 month
Measured in days from intervention to return to pre-injury activity level or occupational function Reduction in pain and itching symptoms associated with burn scars, measured using Vancouver Scar Scale (VSS). Total scores range from 0 to 13, based on four parameters (vascularity, pigmentation, pliability, and height). Lower scores indicate more normal scar characteristics; higher scores reflect worse scar severity.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 6, 2025

First Submitted That Met QC Criteria

September 15, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7723619
  • U1111-1325-8730 (Other Identifier: Universal Trial Number - WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data (IPD) from this study. Although the data will be de-identified, the nature of the study population and clinical context may still pose a residual risk of re-identification. Additionally, institutional policies and ethical considerations restrict public sharing of participant-level data without explicit consent for secondary use.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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