A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 16
- 主要终点
- Change in Exudate Status From Baseline to Last Visit
研究概览
简要总结
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
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
- •Signed Informed Consent Form
- •Both gender ≥ 18 years old
- •From Medium to High exuding wound
排除标准
- •Known allergy or hypersensitivity to any of the treatment dressings
- •Pregnant or lactating females
- •Subjects with a target wound that is ≤1 cm2
- •Subjects with a target wound that is a full thickness burn
- •Subjects with a target wound that is a full thickness pressure ulcer
- •Subjects with known immunodeficiency
- •Subject taking systemic antibiotics for wound infection
- •Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
- •Subject with a target wound with unexplored enteric fistula
- •Subjects who in the opinion of the investigator, will have problems following the protocol
- •Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- •Previously enrolled in the present investigation
- •Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- •Involvement in the planning and conduct of the clinical investigation
结局指标
主要结局
Change in Exudate Status From Baseline to Last Visit
时间窗: 4 weeks (28 days) or earlier if the wound is dry or healed
The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05. If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.
次要结局
- 4-Week Wound Status(At 4 weeks (28 days))
- Wound Area Reduction (mm^2)(Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed)
- Frequency of Dressing Changes Between Visits(Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed)
- Tissue Type of Wound Bed(Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed)
- Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation(Total treatment period of 4 weeks (28 days))
- Comfort, Conformability, and Acceptability of the Dressings by Subject(At 4 weeks (28 days) or earlier if the wound is dry or healed)
- Handling and Technical Performance of the Dressing(At 4 weeks (28 days))
- Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour(Total treatment period of 4 weeks (28 days))
- Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration(Total treatment period of 4 weeks (28 days))