Assessment of the Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings in Local Management of Acute and Chronic Wounds at Risk of Local Infection or With Clinical Signs of Local Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- relative wound area reduction (RWAR)
研究概览
简要总结
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection
详细描述
prospective multicenter, non comparative clinical investigation
This is a prospective multicenter, non comparative open-label, clinical investigation conducted in patients with acute and chronic wounds at risk of local infection or with clinical signs of local infection.
This study is carried out in France and Spain in around 30 investigator sites. A total of 85 patients meeting the eligibility criteria will be included. The patients will be followed for 4 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied wounds is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 1, Week 2, Week 3 and Week 4).
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
- •Related to all wounds :
- •Adult patient having given free, informed and written consent
- •Patient affiliated to a social security insurance scheme (applicable For France),
- •Inpatient or outpatient who can be followed by the same investigative team throughout the investigation,
- •Acute wound (burn, traumatic wound, unstitched surgical wound) or chronic wound (leg ulcer, pressure ulcer, diabetic foot ulcer),
- •Wound whose surface can be covered by a single dressing,
- •Wound at least 3 cm from any edge of another wound.
- •Related to acute wounds, leg ulcer, pressure ulcer:
- •Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 3 of the following clinical signs:
- •Pain (spontaneous, pressure pain or increased pain),
- •Peri-wound erythema,
- •Oedema, induration or swelling,
- •Odour (increase, change),
- •Exudate (colour modification or increase of exudate),
- •Local warmth,
- •Hypergranulation,
- •Bleeding, friable granulation tissue,
- •Stagnant healing/wound deterioration.
- •Related to diabetic foot ulcer :
- •Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 2 of the following clinical signs:
- •Pain (spontaneous, pressure pain or increased pain),
- •Peri-wound erythema between 0.5-2.0 cm around the wound,
- •Oedema, induration or swelling,
- •Odour (increase, change),
- •Exudate (colour modification or increase of exudate),
- •Local warmth,
- •Hypergranulation,
- •Bleeding, friable granulation tissue,
- •Stagnant healing/wound deterioration,
排除标准
- •Patient with a wound for which treatment in a hyperbaric chamber is planned within 4 weeks following inclusion,
- •Patient with a serious general condition, that could lead to withdrawal from the trial before four weeks of treatment,
- •Patient who has experienced an acute ischaemic event (acute myocardial infarction or stroke) during the 3 months prior to inclusion in the investigation,
- •Patient with a systemic infection
- •Wound totally or partially covered on its surface with a black plaque of necrosis,
- •Cancerous wound
研究组 & 干预措施
medical device under investigation
URGO AWC_008 or URGO AWC_022 dressing. These 2 dressings are similar and only the adhesive constitutes a difference. The choice of study dressing will be left to the discretion of the investigator during the treatment of the patient, depending on the nature of the wound and the condition of the peri-wound skin.
干预措施: URGO AWC_008 dressing or URGO AWC_022 dressing (Device)
结局指标
主要结局
relative wound area reduction (RWAR)
时间窗: 4 week treatment period
changes in the area of wounds after 4 weeks of treatment.
次要结局
- percentage of patients whose wound has healed(4 week treatment period)
- Nature and incidence of Treatment Adverse Effects as assessed in percentage for each dressing(4 week treatment period)