Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- treatment results
研究概览
简要总结
Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC], is a relatively new method of treatment and knowledge about its effect on patients is limited.
Earlier studies haven't been able to answer the question about which groups of patients that are in most favour of the treatment and what impact the treatment has on the patient's quality of life.
It is important with further research since an effective and mild wound treatment can decrease suffering and increase quality of life for the patient. Wound treatment that does not lead to an achieved treatment goal can lead to a risk for the patient and should be avoided.
The project consists of 4 part studies: Study 1 and 2 are chart review studies of a consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The patients are described on the basis of medical, surgical and demographical factors. Outcome is treatment results and risk factors for a treatment failure.
Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with VAC provides a faster and more effective healing of acute and postoperative wounds, and in what way the treatment affect the quality of life and pain of the patients, compared to conventional treatment.
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
- Single (Outcomes Assessor)
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 wounds with substance defect after primary suture demanding further treatment or wounds not primary sutured
- •wounds with osteosynthesis, bone or tendon visual regardless wound size
- •postoperative infections with wound and substance defect demanding further treatment.
- •fasciotomy on extremity
排除标准
- •wound size < 2 cm and depth < 1 cm
- •pressure ulcers, open abdomen and chronic ulcers
- •patients with dementia or mental illness so severe that participation in the study is impossible
- •patients non in command of the swedish language
- •ongoing treatment with warfarin
研究组 & 干预措施
Conventional treatment
干预措施: Conventional treatment (Procedure)
VAC treatment
干预措施: VAC treatment (Procedure)
结局指标
主要结局
treatment results
时间窗: 2 weeks
successfully treated or non-successfully treated
wound size
时间窗: 2 weeks
meassured with Visitrak
Quality of life
时间窗: 2 weeks
meassured with EQ-5D form and a diary with content analysis
次要结局
- costs for treatment(2 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(2 weeks)
研究者
Ann-Mari Wallin
RN, PhD
Karolinska Institutet