AzTrials
AzTrials

Autologous Fat GraftingBURNSCARCARENCT07186322

Autologous Fat Grafting in Upper Limb Burns Scars

A study testing Fat Graft in people with Autologous Fat Grafting and Burn, run by Federal University of São Paulo at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Fat Graft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
1 Jul 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University Of São Paulo

    São Paulo, São Paulo, 04040030

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Fat Graft
Keywords
randomized clinical trial, burns, autologous fat grafting, corticosteroid injection
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fat GraftProcedure or surgery

    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.

Study groups in NCT07186322
Study groupRoleWhat they receive
Experimental Group - Fat GraftExperimentalParticipants 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.
Receives: Procedure: Fat Graft
Control Group - Corticosteroid InjectionActive comparatorParticipants 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.
Receives: Procedure: Fat Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after intervention

Secondary outcomes (4)

  1. Need for Additional Interventions

    Number and type of additional procedures (e.g., re-injection, new surgical release, corticosteroid reapplication) required during the follow-up period.

    Measured: 6 month

  2. Incidence of Adverse Events

    Occurrence of treatment-related complications such as fat necrosis, infection, contour irregularities, delayed healing, or systemic adverse events.

    Measured: 1 week, 1 month and 6 month

  3. Scar improvment measure by other scales - Patient Scar Assessment Scale

    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.

    Measured: 6 month

  4. Scar improvment measure by other scales - Vancouver Scar Scale

    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.

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Jul 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186322
Sponsor's protocol ID
7723619
Other IDs
U1111-1325-8730
Acronym
BURNSCARCARE
Status last verified
Sep 2025
First submitted
6 Aug 2025
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Hoerst K, van den Broek L, Sachse C, Klein O, von Fritschen U, Gibbs S, Hedtrich S. Regenerative potential of adipocytes in hypertrophic scars is mediated by myofibroblast reprogramming. J Mol Med (Berl). 2019 Jun;97(6):761-775. doi: 10.1007/s00109-019-01772-2. Epub 2019 Mar 19.

    PubMed 30891616

  • Karakol P, Bozkurt M. Recent strategic approach in postburn extremity scars and contractures. J Plast Surg Hand Surg. 2021 Jun;55(3):153-161. doi: 10.1080/2000656X.2020.1856670. Epub 2020 Dec 14.

    PubMed 33315507

  • Jaspers MEH, Brouwer KM, van Trier AJM, Middelkoop E, van Zuijlen PPM. Sustainable effectiveness of single-treatment autologous fat grafting in adherent scars. Wound Repair Regen. 2017 Apr;25(2):316-319. doi: 10.1111/wrr.12521. Epub 2017 Apr 24.

    PubMed 28370844

  • Simonacci F, Bertozzi N, Grieco MP, Grignaffini E, Raposio E. Procedure, applications, and outcomes of autologous fat grafting. Ann Med Surg (Lond). 2017 Jun 27;20:49-60. doi: 10.1016/j.amsu.2017.06.059. eCollection 2017 Aug.

    PubMed 28702187

  • Negenborn VL, Groen JW, Smit JM, Niessen FB, Mullender MG. The Use of Autologous Fat Grafting for Treatment of Scar Tissue and Scar-Related Conditions: A Systematic Review. Plast Reconstr Surg. 2016 Jan;137(1):31e-43e. doi: 10.1097/PRS.0000000000001850.

    PubMed 26710059

  • Jaspers MEH, Brouwer KM, Middelkoop E, van Zuijlen PPM. Autologous fat grafting; it almost seems too good to be true. Burns. 2017 May;43(3):690-691. doi: 10.1016/j.burns.2017.01.039. Epub 2017 Mar 1. No abstract available.

    PubMed 28258778

  • Lesmanawati FE, Windura CA, Saputro ID, Hariani L. Autologous fat grafting and adipose-derived stem cells therapy for acute burns and burn-related scar: A systematic review. Tzu Chi Med J. 2024 Mar 6;36(2):203-211. doi: 10.4103/tcmj.tcmj_189_23. eCollection 2024 Apr-Jun.

    PubMed 38645780

  • Abu Alqam R, Alshammari AJ, Alkhwildi LA, Bamatraf MS, Khashab RM, Al Dwehji AMO, Alsuayri RA, Fadel ZT. Effectiveness of Autologous Fat Grafting in the Treatment of Scars: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2024 Oct;48(19):3945-3961. doi: 10.1007/s00266-024-04131-w. Epub 2024 Jul 16.

    PubMed 39014237

  • Piccolo NS, Piccolo MS, Piccolo MT. Fat grafting for treatment of burns, burn scars, and other difficult wounds. Clin Plast Surg. 2015 Apr;42(2):263-83. doi: 10.1016/j.cps.2014.12.009. Epub 2015 Feb 21.

    PubMed 25827568

  • Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.

    PubMed 19407619

  • 28. Linhares CB, Viaro MSS, Collares MVM et al. Tradução para o português da Patient and Observer Scar Assessment Scale (POSAS). Rev Bras Cir Plást. 2016;31(1):95-100.

  • Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

    PubMed 8263569

  • 26. Santos MC, Tibola J, Marques CMG. Tradução, revalidação e confiabilidade da Escala de Cicatrização de Vancouver para língua portuguesa - Brasil. Rev Bras Queimaduras. 2014;13(1):26-3.

  • Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.

    PubMed 2373734

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

    PubMed 22019563

Questions about this trial

What is this clinical trial studying?

A study testing Fat Graft in people with Autologous Fat Grafting and Burn, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS) (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186322, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in