NCT05234658招募中2 期
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Andalusian Network for Design and Translation of Advanced Therapies8 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年1月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Safety of autologous bioengineered skin
研究概览
简要总结
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
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
- 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
- •Patients that give their informed consent for study participation.
- •Adult (18 years of age or older), of any sex and racial origin.
- •Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. Namely, indication for Mohs surgery.
- •Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.
排除标准
- •Locally advanced basal cell carcinoma with evidence of tissue infiltration.
- •Lesions in the face.
- •Injuries requiring urgent surgical intervention.
- •Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
- •Injuries that have received treatment with radiotherapy.
- •Contraindication for Mohs surgery.
- •Known allergies to Biobrane dressing.
- •Pregnant or breastfeeding women.
- •Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
- •Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
结局指标
主要结局
Safety of autologous bioengineered skin
时间窗: Through study completion, an average of 2 year
Incidence of adverse events related to investigational medicinal products
Efficacy of autologous bioengineered skin
时间窗: Through study completion, an average of 2 year
Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis
次要结局
未报告次要终点
研究者
研究点 (8)
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