Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Performance of Hyalo4 Skin Gel treatment
研究概览
简要总结
Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management
详细描述
Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites.
A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.
The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed written informed consent.
- •Male or female ≥18 years.
- •Patients selected to be treated with Hyalo4 Skin Gel.
- •Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- •Patients followed on an outpatient or home basis.
- •Wound area ≥ 10 cm2 and ≤ 100 cm2
排除标准
- •Patients < 18 years.
- •Patients with acute or chronic infected lesions.
- •Hospitalized patients.
- •Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
- •Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
- •Stalled wound, without any clinical sign of healing progression
- •Immune system disorders
- •Protein-energy malnutrition
- •Alcohol, smoking and drug abuse (50ml of spirit, 0,5L of wine and 10 cigarettes/day)
- •Conditions associated with hypoxia and/or poor tissue perfusion
- •Corticosteroid, cytotoxic or immunosuppressive therapy.
- •Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement
结局指标
主要结局
Performance of Hyalo4 Skin Gel treatment
时间窗: 14 days
The outcome will be measured as percentage of patients showing positive change in at least one of the following parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
次要结局
- Safety and Tollerability(56 days)
- EQ5D-Patient's quality of life(56 days)
- Performance of treatment(7,21,28,42 and 56 days)