Autologous Fat Grafting in Upper Limb Burns Scars

NCT07186322 | Active Not Recruiting DMC

• 2 other identifiers: 7723619U1111-1325-8730
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autologous Fat Grafting; Burn; Corticosteroid Injection

Keywords

randomized clinical trial; burns; autologous fat grafting; corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS)

  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 Outcomes (4)

• Need for Additional Interventions

  6 month

• Incidence of Adverse Events

  1 week, 1 month and 6 month

• Scar improvment measure by other scales - Patient Scar Assessment Scale

  6 month

• Scar improvment measure by other scales - Vancouver Scar Scale

  6 month

Study Arms (2)

Experimental Group - Fat Graft

EXPERIMENTAL

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

Control Group - Corticosteroid Injection

ACTIVE COMPARATOR

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

Interventions

Fat Graft PROCEDURE

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.

Control Group - Corticosteroid Injection; Experimental Group - Fat Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University Of São Paulo

São Paulo, São Paulo, 04040030, Brazil

Location

Related Publications (35)

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MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Although participants and treating physicians will be aware of the assigned intervention (open-label), outcome assessment will be blinded. At the 6-month follow-up, standardized clinical photographs of the treated areas will be obtained under controlled conditions and independently evaluated by an external assessor who will be blinded to the treatment group. This approach aims to minimize bias in the subjective assessment of scar quality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Graduate in Translational Surgery. Plastic Surgery Division Resident

Model Details: This is a prospective, randomized, controlled, single-center clinical trial with a parallel assignment design. Eligible adult patients with upper limb burn sequelae (functional contractures and/or pathological scars) will be randomly assigned in a 1:1 ratio to one of two treatment groups: (1) autologous fat grafting or (2) standard treatment (corticosteroid injection). Randomization will be conducted using a secure, computer-generated sequence through sealed opaque envelopes. Masking will be used only for the outcomes assessment; both patients and investigators will be aware of the assigned intervention. Participants will be followed for 6 months after treatment and evaluated at baseline and during follow-up using validated instruments. The primary objective is to compare the effectiveness of fat grafting versus standard treatment in improving scar quality and upper limb function.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)