A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Granulation tissue formation
研究概览
简要总结
The investigation is designed as a prospective, open, non-controlled clinical investigation.
详细描述
Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.
10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.
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
- •Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- •3 cm2 ≤ Wound size ≤ 300 cm2
- •Male or female ≥18 years
- •Signed Informed Consent Form
排除标准
- •Need for frequent dressing changes, i.e.<48 hours between the changes
- •Malignancy in the wound and/or wound margin
- •Untreated osteomyelitis
- •Untreated infection waiting for other intervention
- •Unexplored fistulas
- •> 10% necrotic tissue with eschar present after debridement
- •High risk for bleeding complications (including subject treated with anticoagulants that are associated with high risk for bleeding complications)
- •Exposed blood vessels, organs or nerves
- •Current or within 3 months treatment with chemotherapy or irradiation
- •Known hypersensitivity to the dressing material
- •Expected technically impossible to seal the film to achieve a vacuum treatment
- •Expected non compliance with the Clinical Investigation Plan
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
- •Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start
- •Subject unable to understand written patient information due to medical condition
结局指标
主要结局
Granulation tissue formation
时间窗: maximum 3 weeks
To assess the wound healing and granulation tissue formation when using the NPWT system
次要结局
- Handling of NPWT system(maximum 3 weeks)