Autologous Fat Grafting in Upper Limb Burns Scars

Not Applicable

Active, not recruiting

• Conditions: Autologous Fat Grafting; Burn; Corticosteroid Injection

• Registration Number: NCT07186322
• Lead Sponsor: Federal University of São Paulo

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.

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 Timeline

• Study Start: 2025-07-01
• Study First Submitted: 2025-08-06
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-12
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS)	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.

Secondary Outcome Measures

Name	Time	Method
Need for Additional Interventions	6 month	Number and type of additional procedures (e.g., re-injection, new surgical release, corticosteroid reapplication) required during the follow-up period.
Incidence of Adverse Events	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.
Scar improvment measure by other scales - Patient Scar Assessment Scale	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.
Scar improvment measure by other scales - Vancouver Scar Scale	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.

Trial Locations

Locations (1)

Federal University Of São Paulo; 🇧🇷 São Paulo, São Paulo, Brazil