An Open, Single-arm, Multicentre and Interventional Investigation to Evaluate the Debriding Effect of ChloraSolv® on Pressure Ulcers in Need of Debridement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- RLS Global
- 入组人数
- 5
- 试验地点
- 12
- 主要终点
- Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
研究概览
简要总结
This is an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv when used on pressure ulcers in need of debridement. Approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%).
ChloraSolv will be applied 1-2 times per week for 12 weeks or until the wound is deemed clean, whichever occurs first i.e. End of Treatment. A Follow-up visit for wound status evaluation will be performed 6 weeks from End of Treatment. Total time in investigation will be maximum 12+6 weeks.
Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. Photographs of the wound pre and post debridement will be taken at baseline, every week during the treatment period, at End of Treatment and at the Follow-up visit. Photographs will be used to calculate (by PictZar digital planimetry system) the area of devitalized tissue in the wound as well as wound size and calculation of volume.
Wound depth and undermining will be estimated by the investigator at all investigational visits.
A treatment diary will be used in-between the weekly investigational visits to collect any further treatments. The treatment diary will also be filled-in during the follow-up period of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Pressure ulcer in need of debridement
- •Male or female, 18 years of age and above
- •Able to read and understand the Patient Informed Consent and to provide written informed consent. If written consent is not possible due to the condition of the patient, one impartial witness shall sign and date the informed consent.
排除标准
- •Known allergy/hypersensitivity to any of the components of ChloraSolv
- •Pregnancy or breastfeeding
- •Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator
- •Subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments
- •Wound requiring more than two (2) ChloraSolv syringes for one treatment
结局指标
主要结局
Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
时间窗: 1-12 weeks
When the investigator judge that the wound is clean, primary endpoint is reached
次要结局
- Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry(1-18 weeks)
- Answers from overall evaluation by subjects(1-12 weeks)
- Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry(1-18 weeks)
- Wound status i.e. clinical signs of infection at all visits(1-18 weeks)
- Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry(1-12 weeks)
- Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry(1-18 weeks)
- Relative change in wound depth and undermining at End of Treatment and Follow-up, compared to Baseline, assessed by investigator by using a sterile cotton-tipped applicator(1-18 weeks)
- Pain during treatment compared to baseline using a Visual Analogue Scale(1-12 weeks)
- Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation(0-18 weeks)
- Treatment period duration with ChloraSolv(1-12 weeks)
- Number of treatments with ChloraSolv from Baseline until End of Treatment(1-12 weeks)
- Incidence of subjects with complete wound healing during the investigation period(1-18 weeks)
- Answers from overall evaluation by site personnel(Through study completion, an average of 1 year)