Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Fat-graft survival volume
研究概览
简要总结
This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.
详细描述
Autologous fat grafting is emerging as a powerful tool for soft tissue reconstruction and augmentation and is widely used in plastic surgery. However, there is great variability in terms of long-term graft retention (survival). Moreover, the recipient site preparation is the phase of the procedure which received less attention in clinical and pre-clinical investigations. To provide information regarding an effective preparation of the recipient site may potentially lead to improvements in fat graft survival.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Patients presenting with contracted scars or body contouring deformities, especially as a result of previous radiation therapy or infection, in and around the breast.
- •Body mass index superior than 18.5
排除标准
- •Need for antiplatelets drugs in the 5 days before surgery and 3 days after,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his or her family members, employees and other dependent persons,
- •Patients with haemorrhagic diatheses.
研究组 & 干预措施
pre-expansion using Kiwi® VAC-6000M
Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).
干预措施: pre-expansion using Kiwi® VAC-6000M. (Device)
pre-expansion-heating
Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
干预措施: pre-expansion using Kiwi® VAC-6000M. (Device)
pre-expansion-heating
Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
干预措施: pre-heating using Hilotherm Calido®. (Device)
Control
No preconditioning methods will be applied.
pre-expansion using Kiwi® VAC-6000M
Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).
干预措施: pre-expansion-heating (Device)
pre-heating using Hilotherm Calido®.
Pre-Heating will be preformed using a Hiloterm Calido® System.
干预措施: pre-heating using Hilotherm Calido®. (Device)
pre-heating using Hilotherm Calido®.
Pre-Heating will be preformed using a Hiloterm Calido® System.
干预措施: pre-expansion-heating (Device)
结局指标
主要结局
Fat-graft survival volume
时间窗: 24 (+/-2) weeks after surgery
percent remaining
次要结局
- Occurence of Site infection(day 7 (+/-3), week 12 (+/-2), week 24 (+/-2))
- POSAS (Patient and Observer Scar Assesment Scale)(day 7 (+/-3), week 12 (+/-2), week 24 (+/-2))
- Surgical complication rate(day 7 (+/-3), week 12 (+/-2), week 24 (+/-2))
- Pain assessed by VAS (Visual Analogue Scale)(day 7 (+/-3), week 12 (+/-2), week 24 (+/-2))