NCT01286857已完成2 期
A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
Molnlycke Health Care AB6 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
研究概览
简要总结
The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.
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
- •Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
- •1cm2 ≤ wound size ≤ 200cm2
- •Male or female, 18 years and above
- •Signed Informed Consent Form
- •Subject understands the written Patient Information
排除标准
- •Need for frequent dressing changes, i.e.<48 hours between the changes
- •Critical ischemia (for wound healing) according to investigator's judgement
- •Malignancy in the wound and/or wound margin
- •Target ulcer previous not successfully treated with NPWT within 48 hours
- •Poorly controlled diabetes according to investigators judgement.
- •Osteomyelitis which has been left untreated
- •Infection which has been left untreated
- •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 (CIP)
- •Subjects not suitable for the investigation according to the investigator's judgement
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
时间窗: 144 - 288 hours
次要结局
- To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part(144-288 hours)
研究者
研究点 (6)
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