NCT03640871Unknown不适用
Assessment of Efficacy, Tolerance and Acceptability for the Wound Dressing URGO AWC_019 in the Local Treatment of Acute Wounds, Chronic Wounds and Epidermolysis Bullosa Skin Lesions
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Relative evolution of the wound surface (in %) at week 4
研究概览
简要总结
Assessment of efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
详细描述
Non-comparative clinical study, conducted in France, to evaluate efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Related to every wounds types:
- •Patient over 18 years old who has provided his/her written informed consent
- •Patient affiliated to the French Social insurance
- •Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- •Acute wound (postoperative non-cavitary and non-sutured wound, superficial, middle or deep second degree burn, dermabrasion) or chronic wound (venous or mixed leg ulcer, pressure ulcer) or epidermolysis bullosa skin lesion
- •Use of a contact layer as a primary dressing justified by the wound
- •B. Related to leg ulcer:
- •Venous leg ulcer or mixed leg ulcer, i.e. with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3, (0.7≤ABPI≤ 1.3)
- •Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing
- •C. Related to pressure ulcer:
- •Stage 2, 3 according to the EPUAP (European Pressure Ulcer Advisory Panel) classification system
- •Wound on the pelvis (trochanter, ischio or sacrum) or on the heel
排除标准
- •Patient under authorship or guardianship
- •Woman of child-bearing potential who has no effective contraception method
- •Pregnant or breastfeeding woman
- •Patient taking part in another clinical trial
- •Patient with a known allergy to carboxymethylcellulose (hydrocolloid),
- •Patient with a severe illness that might lead to the premature discontinuation of the trial before the 4 weeks of treatment
- •Wound requiring surgical treatment or for which surgery is scheduled during the 4 weeks after inclusion
- •Patient with an evolving neoplasia condition, treated by radiotherapy, chemotherapy or hormone therapy
- •Malignant wound
- •Patient with a systemic infection not controlled by suitable antibiotic treatment,
- •Wound which is clinically infected
结局指标
主要结局
Relative evolution of the wound surface (in %) at week 4
时间窗: 4 weeks
Relative evolution of the wound surface (in %) at week 4
次要结局
- - Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)(4 weeks)
- - Wound dressing safety (occurrence of adverse events)(4 weeks)
- - Percentage of healed wounds (healing rate) after 4 weeks of treatment(4 weeks)
- - Wound healing time (in days)(4 weeks)
研究者
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