Fat Grafting in Upper Limb Burns Scars: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Improvement in Scar Quality in Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 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.
次要结局
- 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)
研究者
Marcelo Oliveira Mourão Junior
PHD Graduate in Translational Surgery. Plastic Surgery Division Resident
Federal University of São Paulo