Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in ulcer surface area
研究概览
简要总结
Chronic leg ulcerations are a great burden for patients and the medical system alike. Frequent outpatient consultations with associated treatment costs and travel costs for the patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There is an increasing need for definitive treatment of especially chronic venous and multifactorial chronic leg ulceration where arterial intervention is not a treatment option.
Minimal invasive surgical interventions that do not require skin grafting can be performed under local anesthesia in an outpatient setting even in multimorbid patients.
Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat, protein, elastin, glycans and other natural skin elements and it can be an effective treatment option in chronic leg ulcerations and is licensed for this use as a medical product in Switzerland. However, limited data without inter-wound bias is available for the use of Kerecis Omega 3 in chronic leg ulcerations.
In this study the investigators propose to investigate the efficacy of Kerecis Omega 3 according to objective wound surface measurements using standardized digital photographs in patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care wound debridement.
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
- 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
- •Any chronic leg ulcer > 4 weeks duration with delayed wound healing (reduction of wound surface of less than 40-50% within 4 weeks under adequate local therapy) without underlying treatable medical conditions
- •Ulcer area at between 5cm2 and 60cm2
- •Bacterial swab sampling prior to study
- •Written study informed consent
排除标准
- •History of Fish allergy or proven Fish allergy
- •Pregnant or breast-feeding women
- •Intention to become pregnant during the course of the study
- •Wound not suitable for dressing: inflammation, fibrin coatings
- •Inability to understand the study consent
结局指标
主要结局
Change in ulcer surface area
时间窗: 12 weeks
Change in ulcer surface area as assessed by standardized photography and digital imaging.
次要结局
- Change in wound microbiota as assessed by alpha diversity of the microbial composition(2, 4, 6 and 12 weeks)
- Change in ulcer surface area(2, 4, 6 and 12 weeks)
- Change in wound microbiota as assessed by beta diversity of the microbial composition(2, 4, 6 and 12 weeks)
- Change in patient quality of life(2, 4, 6 and 12 weeks)