NCT06300762招募中不适用
A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Exudate management performance
研究概览
简要总结
The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.
As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two assessors are blinded to evaluate some outcomes
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
- •Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
- •Participant is mentally and physically able to participate in this study
- •Men, women, diverse ≥ 18 years
- •Participant complies with study visit schedule
- •Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
- •Participant suffers from lower leg ulcer* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
- •Ulcer is not younger than 4 weeks and not older than 1 year
- •Ulcer is ranging between 2 cm2 and 800 cm2
- •One side of the ulcer is not extending 40 cm
- •Depth of ulcer < 2 cm
- •Ankle-brachial pressure index (ABPI) of >0.8 and ≤1.3, measurement not older than 12 months * Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.
排除标准
- •Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
- •Participant is expected not to be willing or able to follow the study outlines and requirements
- •Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
- •Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
- •Participant uses any medication that could potentially delay the wound healing ability
- •Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
- •Participant is pregnant or currently breastfeeding
- •Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone
- •Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone
- •Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days
- •Participant with a history of sensitivity to any of the components of the study product
- •Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant
- •Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial
- •The ulcer has exposed bone, tendon, ligaments and/or joint
- •History of radiation at the study ulcer site
- •Participant's lesion is a primary skin cancer
- •Participant's lesion is the manifestation of a metastasis
结局指标
主要结局
Exudate management performance
时间窗: up to 30 days
Capability to main exudate uptake and retention as well as leakage prevention
次要结局
- Dressing change frequency(up to 30 days)
- Moisture-associated skin damages(up to 30 days)
- Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments)(day 0 and day 30)
- Changes in wound tissue and general wound pain(up to 30 days)
- HCP satisfaction with treatment and product(final study visit)
- Occurrence clinical relevant peri-wound skin changes(up to 30 days)
- Need for debridement after product removal(up to 30 days)
- Patient satisfaction with treatment and product(final study visit)
研究者
研究点 (6)
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