NCT02963519Unknown不适用
Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Qualissima
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Quality of the bud
研究概览
简要总结
Primary objective:
Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture.
Secondary objectives:
- Evaluate the success of hedging gesture
- Assess the quality of the bud by colorimetry
- Assess tolerance
- Collect medical and economic data on the care of patients included
- Evaluate the quality of life of patients
- Assess patient comfort
- Evaluate the ease of use for the caregiver
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman
- •Age from 18 to 65 inclusive
- •Patient with acute or leg sores (s), traumatic, with skin defect with or without external fixators and without exposure to fine fabrics (functional tendon, artery, vessel, bone, osteosynthesis material ...). These wounds may be burns, deep second degree only.
- •Patient having no associated pathology
- •Patient has given its written consent, lighting, dated and signed
- •Patient affiliated to a social security scheme
- •Voluntary Patient and able to comply with the protocol requirements
- •Patient whose wound is located below the knee
- •Patient whose wound date of less than 2 weeks
- •A patient whose wound has a minimum area of 10 cm2
- •Patient whose wound does not require surgical debridement after inclusion (if surgical debridement is necessary, it must be performed before inclusion in the study)
排除标准
- •Pregnant or breastfeeding women
- •Women of childbearing potential not using effective contraception (combined hormonal, IUD) and failing achieving a pregnancy test and getting the result before starting treatment
- •Patients do not speak and do not read French
- •Patient with one or more risk factors such as smoking more than 5 cigarettes a day, diabetes, autoimmune disease
- •Patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy
- •A patient whose wound is located at a place not compatible with the use of VistaCare®
- •Patient with traumatic wound leg with exposure to some tissues (functional tendon, artery, vessel, bone, osteosynthesis material ...)
- •Patient with general signs of infection (temperature, lymphangitis, osteitis proven)
- •Patient with a bleeding wound
- •Patient with a burn to a stage other than deep second degree
- •Patients with a wound whose area is less than 10 cm2
- •Patient with a plague of nontraumatic leg
- •Previous participation in this trial
- •Patient in exclusion period from another clinical trial or participated in a clinical trial in the month before inclusion
- •Patient whose wound is more than 2 weeks
- •Patient whose wound was treated by hyperbaric chamber
结局指标
主要结局
Quality of the bud
时间窗: Change from inclusion day at Day 15 of the quality of the bud
Comparison, after the inclusion in the study, between VistaCare® and dressings on preparation time to a cover gesture by daily visual assessment of the quality of the bud.
次要结局
未报告次要终点
研究者
研究点 (3)
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