NCT03877484已完成不适用
A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
Smith & Nephew Orthopaedics AG6 个研究点 分布在 3 个国家目标入组 43 人开始时间: 2019年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Change in Wound Area From Baseline to End of Study Visit
研究概览
简要总结
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 written informed consent.
- •18 years of age or older.
- •Willing and able to make all required study visits.
- •Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
- •Presence of a moderately to highly exuding wound of at least 3cm2 in size.
- •Presence of a chronic wound of at least 6 weeks duration at the point of enrollment; full-thickness, partial thickness or shallow granulating wounds.
- •Chronic wounds include:
- •pressure ulcers or
- •leg ulcers or
- •diabetic foot ulcers
- •Presence of an acute wound at the point of enrollment; full thickness, partial thickness or shallow granulating wounds
- •Acute wounds include:
- •dehisced surgical or
- •traumatic wounds
- •The patient has a wound size which can be treated with the available sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking care not to cover the entire dressing.
排除标准
- •Subjects with confirmed or suspected clinically infected reference wound.
- •Reference wound undergoing treatment with compression therapy.
- •Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.
- •Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
- •Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- •Subjects who have participated previously in this clinical trial.
- •Subjects with a history of poor compliance with medical treatment.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study
结局指标
主要结局
Change in Wound Area From Baseline to End of Study Visit
时间窗: Baseline through 28 days (±3 days).
Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.
次要结局
- Patient Assessment Scale: Leakage(Baseline through end of treatment, up to 28 days (±3 days))
- Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)(Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days))
- Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)(Baseline, 7 days, 14 days, 21 days, 28 days)
- Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)(Baseline, 7 days, 14 days, 21 days, and 28 days)
- Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)(Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days))
- Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)(Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days))
- Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days)(Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days))
- Exudate Management: Number of Dressings With Leakage(Dressing application to removal, up to 7 days (±3 Days))
- Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days))
- Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days)(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days))
- Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)(Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Reason for Dressing Change(Upon dressing removal, up to 7 days (±3 Days))
- Condition of Surrounding Skin(Baseline and 28 days (±3 Days))
- Signs of Clinical Infection(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Healing of Reference Wound(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Average Dressing Wear Time(Following dressing application, up to 7 days (±3 Days))
- Overall Level of Pain on Dressing Application(Immediately after dressing application)
- Overall Level of Pain During Treatment(During treatment (following each dressing application prior to removal), up to 7 days (±3 Days))
- Overall Level Pain on Dressing Removal(Immediately upon dressing removal)
- Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days)(Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days))
- Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days)(Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Dressing Adherence (Retention)(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Bunching Up of Dressing(7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days))
- Overall Percent of Dressing Lift(Dressing application to removal, up to 7 days (±3 Days))
- Dressing Comfort During Wear(7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days))
- Patient Assessment Scale: Moisture(Baseline through end of treatment, up to 28 days (±3 days))
- Patient Assessment Scale: Odour(Baseline through end of treatment, up to 28 days (±3 days))
- Patient Assessment Scale: Exudate(Baseline through end of treatment, up to 28 days (±3 days))
- Patient Assessment Scale: Protection(Baseline through end of treatment, up to 28 days (±3 days))
- Patient Assessment Scale: Comfort(Baseline through end of treatment, up to 28 days (±3 days))
- Patient Assessment Scale: Showering(Baseline through end of treatment, up to 28 days (±3 days))
研究者
研究点 (6)
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