Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- improvement of scar quality by physiological testing with cutometer
研究概览
简要总结
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
详细描述
Objective
A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.
Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.
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
- Double (Participant, Outcomes Assessor)
盲法说明
2 skin zones per participant, A and B, 1 is treated, 1 is placebo coin toss determines which zone will be treated, this information is kept in sealed envelope
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •early skin-grafted deep burn scars
- •otherwise healthy
排除标准
- •concomitant disease
研究组 & 干预措施
1 group of 15 patients
procedure/surgery: fat grafting injection of scar
干预措施: lipofilling/ fat grafting (Procedure)
Same group of 15 patients
procedure/surgery: placebo injection of scar
干预措施: placebo injection (Procedure)
结局指标
主要结局
improvement of scar quality by physiological testing with cutometer
时间窗: 6 months, 1 year
measures elasticity of the scar; micrometer; higher values better outcome
Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
时间窗: 1 year
numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Improvement of scar quality by histological assessment
时间窗: 6 months
histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)
physiological testing of scar tissue by corneometer
时间窗: 6 months, 1 year
measures hydration of the epidermis; corneometer units, higher values better outcome
Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale
时间窗: 1 year
numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief
improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)
时间窗: 6 months, 1 year
measures transepidermal water loss; g/m2/h; higher values worse outcome
次要结局
未报告次要终点
研究者
Phillip Blondeel
Clinical Professor, Head of Plastic Surgery, Principal Investigator
University Hospital, Ghent