A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
研究概览
简要总结
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
详细描述
ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a variety of wound types. It is widely used in routine clinical practice within the UK. ACTICOAT is CE marked and will be used within the intended indications for use. The proposed study is required for regulatory purposes.
Primary Objective: To evaluate change in health related quality of life, associated with treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single index utility scores from baseline to 3 weeks.
The study will also seek to gather and report relevant safety and performance data and evaluate change, where applicable, for outcomes including: clinical signs and symptoms of infection; wound length / width / depth; wound healing measures; tissue staining; pain, adherence, and pain on application / removal; wear time; adverse events and device deficiencies.
In total 25 participants will be recruited into the trial, comprising a minimum of 8 participants with a full or partial thickness burn and a minimum of 8 participants with a full or partial thickness chronic wound. All participants will have their wound dressed using ACTICOAT, and will be followed-up for 3 weeks.
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
- •Must provide informed consent to participate in the study.
- •Eighteen (18) years of age or older.
- •Males and females.
- •Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately.
- •Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly.
- •Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements:
- •A full or partial thickness chronic (≥ 4 weeks duration) wound, consisting of a Venous Leg Ulcer, Pressure Ulcer or Diabetic Foot Ulcer, which in the opinion of the Investigator, or delegated Sub-Investigator, appears to be infected based on documented clinical signs and symptoms of infection.
- •A recently acquired (≤ 7 days) non-infected burn, comprising a full or partial thickness wound, covering a minimum 0.5% TBSA. The maximum must be less than 10% TBSA. Absence of infection will be determined by the Investigator / Sub-Investigator.
排除标准
- •Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver).
- •Participation in the treatment period of another clinical trial within thirty (30) days of Visit
- •Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit
- •Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments.
- •Patients requiring concomitant use of NPWT on the reference wound.
- •Patients who have participated previously in this clinical trial and who have healed or been withdrawn.
- •Patients with a history of poor compliance with medical treatment.
- •Patients who, in the opinion of the Investigator, are experiencing burn shock.
- •Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
ACTICOAT
ACTICOAT is a silver coated antimicrobial barrier dressing. ACTICOAT dressings consist of three layers: an absorbent inner core of polyester and rayon sandwiched between outer layers of silver coated, low adherent, high density polyethylene mesh.
干预措施: ACTICOAT (Device)
结局指标
主要结局
Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).
时间窗: 21 days
次要结局
- Wound depth(21 days)
- Amount of healthy tissue (% tissue types)(21 days)
- Ease of dressing removal(21 days)
- Serious adverse events(21 days)
- Clinical signs and symptoms of infection(21 days)
- Wound width(21 days)
- Condition of surrounding skin(21 days)
- Extent of tissue staining(21 days)
- Pain on dressing application(21 days)
- Non-serious adverse events(21 days)
- Reference wound healed (% re-epithelialized)(21 days)
- Pain on dressing removal(21 days)
- Ease of dressing application(21 days)
- Device deficiencies(21 days)
- Wound length(21 days)