An Open, Single-centre, Clinical Investigation to Explore the Binding of Bacteria and Fungi to Dialkylcarbamoyl Chloride (DACC)-Coated Dressings From Hard-to-heal Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).
研究概览
简要总结
The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
详细描述
This is a prospective, open, single-centre, exploratory clinical investigation with a primary objective of studying the binding of bacteria and fungi from hard-to-heal wounds to the surface of DACC-coated dressings.
Subjects suffering from hard-to-heal wounds who are due to start using a dressing from the Sorbact range will be recruited at one investigation site in Sweden. The subjects will be divided into three groups by dressing type and there will be 10 subjects in each group, i.e., 10 subjects will be treated with Sorbact® Compress, 10 subjects will be treated with Sorbact® Gel Dressing, and 10 subjects will be treated with Sorbact® Ribbon Gauze. The dressings will be used in accordance with their respective IFU.
The clinical investigation is designed to have a treatment period of 14 days with no additional follow-up.
Three visits are planned for each subject, including a screening/baseline visit at the clinic and two further visits to the study clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Able to read and understand the Subject Information and Informed Consent Form and provide meaningful informed consent
- •Due to start using one of the following dressings: Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
- •Age ≥18 years
- •Presence of hard-to-heal wound for ≥6 weeks with no significant wound area reduction for the last 4 weeks confirmed by investigator/study nurse
排除标准
- •Participating in another clinical investigation
- •Known allergy or sensitivity to any components of the allocated investigational device
- •Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
- •Use of a dressing from the Sorbact® range during the last two weeks
- •Subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate
研究组 & 干预措施
Sorbact® Compress
Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds
干预措施: Sorbact® Compress (Device)
Sorbact® Gel Dressing
Patients already assigned to start treatment with Sorbact® Gel Dressing as it is judged by the investigator to be the most suitable for their wounds
干预措施: Sorbact® Gel Dressing (Device)
Sorbact® Ribbon Gauze
Patients already assigned to start treatment with Sorbact® Ribbon Gauze as it is judged by the investigator to be the most suitable for their wounds
干预措施: Sorbact® Ribbon Gauze (Device)
结局指标
主要结局
Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).
时间窗: 2 days (+1 day)
The measurements that will be used to assess the primary outcome are 16S rRNA sequencing to identify bacterial species, Internal Transcribed Spacer (ITS) sequencing to identify fungal species and scanning electron microscopy (SEM) images for visualization of bacteria and fungi bound to the dressing
次要结局
- Wound bed microbial load at 14 days (±1 days) compared to baseline(14 days (±1 days))
- Wound bed bacteria and fungi species at baseline and at 14 days (±1 days)(14 days (±1 days))
- Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline(14 days (±1 days))
- Wound fluid endotoxin level at 14 days (±1 days) compared to baseline(14 days (±1 days))
- Presence of endotoxin on the dressing after 2 days (+ 1 day)(2 days (+ 1 day))
- Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)(2 days (+ 1 day))