Comparative Clinical, Histological and Ultrasound Pilot Study of Two Hyaluronic Acid Gel Fillers, Designed for Deep Injection, in Adipose Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- tissue inflammation after injection of hyaluronic acid filler
研究概览
简要总结
This study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA), designed for deep injection, that have been used for several years on a worldwide scale.
详细描述
The study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a Wise pattern skin excision (inverted T inframammary scar) Informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked.
Participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery.
In each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface.
Both sessions will be monitored by ultrasound examination. After the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection.
At the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients eligible for and requesting abdominoplasty
- •patients eligible for and requesting bilateral breast reduction
排除标准
- •Patients prone to hypertrophic scarring or keloids
- •Hypersensitivity to hyaluronic acid
- •Hypersensitivity to lidocaine or amide type local anaesthetics
- •Autoimmune disease
- •Severe, multiple allergies or anaphylactic shock
- •Heart rhythm disorders
- •Porphyria, congenital methemoglobinemia, glucose-6 phosphate dehydrogenase deficiencies, treatment with methaemoglobin-inducing substances.
- •Previous streptococcal disease (acute rheumatic fever whether or not with heart valve involvement)
- •Patients on medication which slows hepatic metabolism (such as cimetidine, beta-blockers)
- •Diabetes requiring insulin treatment
- •Major system disease.
- •Coagulation disorders. Anticoagulation therapy. Chronic use of acetylsalicylic acid.
- •Previous surgery in the areas eligible for injections.
- •All contraindications to their surgical treatment (such as pregnancy or lactation).
研究组 & 干预措施
Hyaluronic Acid filler 1 for deep injection
Injection Session 1 of Hyaluronic Acid filler 1, 3 weeks to 4 months before the surgery
Injection Session 2 of Hyaluronic Acid filler 1, 5 to 9 days before the surgery
干预措施: Hyaluronic Acid filler (Device)
Hyaluronic Acid filler 2 for deep injection
Injection Session 1 of Hyaluronic Acid filler 2, 3 weeks to 4 months before the surgery
Injection Session 2 of Hyaluronic Acid filler 2, 5 to 9 days before the surgery
干预措施: Hyaluronic Acid filler (Device)
结局指标
主要结局
tissue inflammation after injection of hyaluronic acid filler
时间窗: 3 weeks to 4 months after injection
Presence of lymphocytes and/ or histiocytes around the filler through histologic examination \[Yes/No\]
次要结局
- tissue response after injection of hyaluronic acid filler(1 week after injection)
- tissue response after injection and remodelling of hyaluronic acid filler(1 week after injection)
- filler distribution in tissue(1 week after injection)