Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Wound surface area
研究概览
简要总结
The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.
详细描述
The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
- •Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
- •Patient willing and able to wear an effective venous compression system every day during the study period,
- •Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.
排除标准
- •Patients under guardianship or protection of vulnerable adult
- •Pregnancy or breastfeeding women,
- •Childbearing potential women with no medically-acceptable method of birth control,
- •Patients included in another clinical study,
- •Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
- •Patients with wound covered partially or totally with necrotic tissue,
- •Patients who had within the 3 months prior the inclusion, deep vein thrombosis
- •Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
- •Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
- •Patients with non-controlled systemic infection by an suitable antibiotic therapy
- •Patients with clinically infected wound
- •Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
- •Patients with known cancerous lesions
研究组 & 干预措施
URGO2875
Dressing
干预措施: URGO2875 (Device)
结局指标
主要结局
Wound surface area
时间窗: 4 weeks
Relative wound surface area reduction (%) at the end of the four weeks of treatment
次要结局
- Healing(4 weeks)
- Inflammatory clinical signs(4 weeks)
- Time to healing(4 weeks)
- Percentage of wounds with a favourable outcome(4 weeks)
- Patient quality of life(4 weeks)