A Multi-Centre, Post CE Mark, Open Clinical Investigation to Evaluate an Abdominal NPWT (Negative Pressure Wound Therapy) System (Avance® Pump and Avance® Foam Abdominal Dressing Kit) in Subjects With Open Abdominal Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings
研究概览
简要总结
The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.
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
- •Provision of written informed consent from subject or family member
- •Subjects with open abdomen suitable for temporary closure with NPWT therapy
- •Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)
- •Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit
- •Male or female, 18 years and above
排除标准
- •Synthetic mesh inserted in the abdomen
- •Non-enteric fistulae or unexplored fistulas
- •Untreated osteomyelitis
- •Malignant wounds
- •Abdominal wall hernia
- •Subjects previously treated with an NPWT abdominal dressing
- •Known allergy or hypersensitivity to any of the components in the dressing
- •Subjects not suitable for the investigation according to the investigator's judgement
- •Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator
结局指标
主要结局
To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings
时间窗: From 1 to 3 visit, depending on each subject/wound, up to 4 days.
Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0 Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0
次要结局
- - Fascial/Skin Closure of the Open Abdomen(End of treatment, up to 4 days.)