NCT04652752终止不适用
A Prospective, Open, Clinical Trial to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
Fidia Farmaceutici s.p.a.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in dimentions of lesion in patients compared to baseline
研究概览
简要总结
This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Male or female ≥ 18 and ≤ 85 years
- •Having a superficial cutaneous lesion of different etiology, with the following characteristics:
- •Wound bed appearance of grade ≥15 of WBS (Wound Bed Score: Falanga 2006) Absence of clinical signs or symptoms of local infection (as defined by CDC/NHSN) Size: between 5 and 32 cm2 that can be covered by a dressing of 4x8cm
- •In case of multiple lesions per patient, only one lesion will be considered for the treatment (the better choice for self-evaluation of lesion by patient)
- •Patient able to maintain a Patient's Diary during the study
- •Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
- •Ensured compliance of subjects for the study period
排除标准
- •Patients who not sign the informed consent form
- •Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
- •Patients with WBS score under or equal to 14 ("severe exudate amount", or "moderate exudate amount" and "moderate per-wound dermatitis" or "moderate callous peri-wound")
- •Presence of signs of infection as defined by CDC/NHMS
- •History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- •Uncontrolled congestive heart failure
- •Active malignant disease
- •Active sickle cell disease
- •Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
- •Known allergy to any of the devices' constituents
- •Women who are pregnant, breastfeeding or who have not reached menopause and are not abstinent or practicing an acceptable means of birth control as determined by the Investigator for the duration of the study
结局指标
主要结局
Change in dimentions of lesion in patients compared to baseline
时间窗: at 14 days
Change from of superficial cutaneous lesions by measuring the area of the superficial lesion after 14 days of treatment
次要结局
- Clinician's global assessment of the lesion (CGA)(at 2,8, 14, 20 and 26 days)
- Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH(at 2,8, 14, 20 and 26 days)
- Patient's satisfaction with CONNETTIVINA HI TECH(at 2,8, 14, 20 and 26 days)
- Evaluation of dressing Adhesion(at day 28)
- Number of Participants With Treatment-Related Adverse Events(at 2,8, 14, 20 and 26 days)
研究者
研究点 (1)
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