NCT00471939已完成2 期
A Phase II, Multi-Centre, Controlled Study of the Safety and Efficacy of Wound Healing Gel I-020502 (KUR-212) in Patients Undergoing Autologous Meshed Skin Grafting.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of treatment-related adverse events up to 28 days post surgery
研究概览
简要总结
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by the patient or his/her legal representative.
- •Male or female, aged ≥ 18 years.
- •Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
- •Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
- •Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 cm
- •Patients who are willing to comply with treatment applications and instructions by the protocol.
排除标准
- •Females who are pregnant or breast-feeding.
- •Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
- •Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
- •Electrical and/or chemical burns.
- •Patients that are judged to have significant pulmonary compromise.
- •Transcutaneous tissue oxygenation < 90%.
- •Clinically significant infections at wound sites.
- •Clinically significant systemic infections.
- •Suspicion or presence of active systemic or local cancer or tumor of any kind.
- •Patients with known immunodeficiency disorders, either congenital or acquired.
- •Patients with vascular or skin disorders that directly affect the designated wound site.
- •Patients with Diabetes mellitus.
- •Patients with chronic malnourishment.
- •Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
- •Any other acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to skin mesh grafting and study participation.
- •Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.
结局指标
主要结局
Incidence of treatment-related adverse events up to 28 days post surgery
时间窗: 28 days
次要结局
- Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments(28 days)
研究者
研究点 (2)
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