NCT05632250已完成不适用
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings in the Management of Indicated Chronic Wound Types.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 10
- 主要终点
- To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
研究概览
简要总结
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
详细描述
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)
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
- •Patients aged 18 years and over
- •Patients able and willing to provide informed consent
- •Patients with wounds with a duration of no less than 2 months and no more than 12 months
- •Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
- •Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:
- •Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers)
- •Pressure Injury Stage II or greater
- •Patients must be willing to attend visits as per schedule in protocol
排除标准
- •Patients with known allergies to any of the materials used in the dressing
- •Patients with known malignant wounds
- •Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
- •Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
- •Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
结局指标
主要结局
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
时间窗: 12 weeks
This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change
次要结局
- To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use(12 weeks)
- To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use(12 weeks)
- To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use(12 weeks)
- To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use(12 weeks)
研究者
研究点 (10)
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