Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Histological analysis of rete ridges of scar tissue
研究概览
简要总结
The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.
详细描述
Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study.
After bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a control. Part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. Ten months after DIEP flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. At that time photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale (POSAS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patient, investigator, outcome assessor will be blinded for which side of the scar was injected with stromal vascular fraction. Only the surgeon will know which site was injected.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction
排除标准
- •immunosuppressive disease
结局指标
主要结局
Histological analysis of rete ridges of scar tissue
时间窗: 10 months
Number of rete ridges of scar tissue on the injected and control site will be compared.
Histological quantification of elastin of scar tissue.
时间窗: 10 months
Quantification of elastin of scar tissue will be compared on the injected and control site.
Histological quantification of vascularity in scar tissue
时间窗: 10 months
Vascularity will be histologically quantified and compared on the injected and control site.
Histological quantification of inflammatory cells in scar tissue
时间窗: 10 months
Inflammatory cells will be histologically quantified and compared on the injected and control site.
Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 10 months
Scar will be evaluated by the Patient and Observer Scar Assessment Scale. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. The sum altogether will give the 'Total Score' of the POSAS. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'.
Analysis of stromal vascular fraction by flow cytometry
时间窗: 2 hours
Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.
Histological analysis of epidermal thickness of scar tissue
时间窗: 10 months
Epidermal thickens of scar tissue on the injected and control site will be compared.
次要结局
未报告次要终点
研究者
Katarina Zivec
Principal Investigator
University Medical Centre Ljubljana