Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
试验速览
- 阶段
- 不适用
- 发起方
- Regen Lab SA
- 入组人数
- 56
- 主要终点
- Time to drain removal
研究概览
简要总结
Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in plastic surgery. However, only pilot studies and retrospective uncontrolled trials have reported the potential benefits of autologous glue treatment up to now. Therefore, a larger, blinded, randomized and placebo-controlled clinical trial would be useful to determine whether platelet-rich plasma is safe and effective in abdominoplasty procedures.
Currently, there are pharmacological options such as artificial fibrin glues composed of homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk of transmissible diseases and may induce allergic reactions. Therefore, autologous glues, which are fully made of blood components from the patient itself (autologous fibrinogen contained in PRP and autologous thrombin) represents a safe alternative to artificial biological glues.
Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an autologous activated thrombin serum, on the other hand, in a safe and rapid manner. RegenKit®-Surgery is a CE-marked class IIb medical device.
This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared with RegenKit®-Surgery when used in reconstructive abdominoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with an indication for abdominoplasty
- •Signature of informed consent form
- •Capable of understanding the study's imperatives
排除标准
- •Participation -ongoing or in the last two months- in another clinical trial
- •Pregnancy or breastfeeding
- •Auto-immune disease (e.g. Hashimoto, rheumatoid arthritis, lupus, etc.)
- •Hereditary or acquired hematologic disorder (e.g. drepanocytosis, etc.)
- •Haemoglobin < 10g/dl
- •Haematocrit < 33%
- •Hereditary or acquired coagulation disorder (e.g. platelet dysfunction syndrome, critical thrombocytopenia with a platelet count < 150'000/microlitre, impaired coagulation,etc.)
- •Systemic disorders such as diabetes, or hepatitis
- •Acute infection
- •Any active malignancy
- •Chemotherapy
- •Refusal or incapacity to give Informed Consent
结局指标
主要结局
Time to drain removal
时间窗: Maximum of 10 days
Period of time needed until the drain can be removed after surgery
次要结局
- Volume of exsudates coming from the drain daily(Maximum of 10 days)
- Percentage of patients with post-operative collections after drain removal(2 weeks after surgery)
- Reoperation rate(6 months)
- Incidence and severity of adverse events(6 months)