A Pilot Study to Investigate the Relative Effectiveness and Safety of Chemical Wound Debridement and Curettage in the Treatment of Venous and Mixed Aetiology Leg Ulcers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Wound surface
研究概览
简要总结
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.
详细描述
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom
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
- •Participants with a venous leg ulcer or mixed aetiology ulcer.
- •Duration of wound ≥ 6 weeks ≤ 5 years
- •Wound is ≥ 5 cm2 ≤ 200cm2
- •Presence of at least 25% visible slough within the wound bed
- •The Participant must be able to understand the study and provide written informed consent
- •No clinical signs of infection
排除标准
- •Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial
- •Current local or systemic antibiotics in the week prior to inclusion
- •Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema
- •Prolonged treatment with immunosuppressive agents or high dose corticosteroids
- •Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
- •Participants who have participated in a clinical trial on wound healing within the past month
- •Participants with a known history of non- adherence with medical treatment
研究组 & 干预措施
Chemical Debridement
1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial
干预措施: Chemical Debridement (Device)
Sharp debridement
In the control arm wound debridement by curettage will be performed at initiation visit and after 2 weeks when clinician deems this necessary, conform standard of care protocol
干预措施: Curettage debridement (Device)
结局指标
主要结局
Wound surface
时间窗: 12 weeks
Change in wound surface area (cm\^2)
Wound Debris
时间窗: 12 weeks
Change in the percentage of the wound bed covered with slough
次要结局
- Wound healing(12 weeks)
- Quality of Life(12 weeks)
- Patient Comfort in treatment process(12 weeks)
- Device Safety(12 weeks)
- Treatment Comfort in performance and acceptance(12 weeks)
- wound condition(12 weeks)