Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Exudate absorption by IMD ('yes', 'no')
研究概览
简要总结
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients.
Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites.
During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.
详细描述
This Post Market Clinical Follow up (PMCF) study will examine product features of the CE-marked wound dressing after having received market authorization regarding the fulfilment of predefined requirements for the successful management of skin integrity during wound care. The primary purpose of this study is to evaluate clinical safety and performance of the product when used on several wounds in routine wound care without any additional invasive or burdensome methods and within the intended use.
As primary objective the dressing´s absorption performance and its ability to prevent exudate accumulation in the wound will be investigated. Further, device disintegration, need of debridement, wound and skin conditions, treatment related pain, general wound pain, dressing adhesion and quality of life as well as Helath Care professional's (HCP´s) and patient´s satisfaction are considered as secondary outcomes.
In total, 36 eligible subjects will be enrolled at 2 German sites, including 15 % dropouts.
5 on-site visits are to be performed by the subjects in the scope of routine weekly wound care/dressing change visits during 28 days (Day 0, Day7, Day 14, Day21, Day28). The IMD will be applied during each on-site visit including wound care, wound examination/documentation and dressing change according to HCP's judgment and individual circumstances of the wound. Photographic documentation of the wound and the wound with applied dressings will be performed and used for further automatic wound/tissue analyis. General wound pain as well as pain perceived during dressing change will be documented, as well as Wound-related Quality of life as well as Patient's/HCP's satisfaction with the product.
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
- •mentally and physically able to participate in study
- •written informed consent to participate in the study
- •Diagnosed wound indicated for treatment with Cutimed® Gelling Fiber for 4 weeks (except for internal body cavities and closed wounds)
- •Subjects with more than one ulcer are eligible for inclusion, however only one ulcer per subject will be included in the study.
排除标准
- •Sensitivity to or allergic reaction to the dressing or its components
- •Participation in any other clinical study investigating drugs or medical devices
- •Subjects presenting with wounds including internal body cavities or closed wounds
- •Alcohol and drug addiction
- •Pregnant or breast-feeding subjects
- •Underlying diseases are not treated according to respective country-specific guidelines
结局指标
主要结局
Exudate absorption by IMD ('yes', 'no')
时间窗: day 28
Percentage of subjects with exudate absorbed by the IMD per visit
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
时间窗: day 28
Percentage of subjects with remaining exudate in wound per amount and visit
次要结局
- Changes in peri-wound skin condition(Throughout days 0, 7, 14, 21 and 28)
- Changes in wound tissue type(Throughout days 0, 7, 14, 21 and 28)
- Ease of removal(Throughout days 7, 14, 21 and 28)
- Changes in wound-pain(Throughout days 7, 14, 21 and 28)
- Incidence of adverse events related to IMD(Throughout days 0, 7, 14, 21 and 28)
- Changes in debridement ease(Throughout days 0, 7, 14, 21 and 28)
- Pain on removal(Throughout days 7, 14, 21 and 28)
- Incidence of device disintegration (removability in one piece)(Throughout days 0, 7, 14, 21 and 28)
- Changes in wound margin condition(Throughout days 0, 7, 14, 21 and 28)
- Ease of application(Throughout days 0, 7, 14, 21 and 28)
- Changes in Wound-quality of life Wound-QoL(Day 0 and Day 28)
- Changes in need for debridement(Throughout days 0, 7, 14, 21 and 28)
- Conformability during application(Throughout days 0, 7, 14, 21 and 28)
- Dressing adherence on removal(Throughout days 7, 14, 21 and 28)
- HCP Overall satisfaction(day 28)
- Subject Overall satisfaction(day 28)