The Use of Biochemical Analyzes to Monitor the Development of Wounds: Part 1: Analysis of Wounds Without VAC Therapy: Part 2: Analysis of Wound Fluids Under VAC Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing negative pressure wound therapy
研究概览
简要总结
Chronic wounds represent a growing challenge in medical care.
Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display an infection prematurely. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) measured overed 3 days, would indicate a change in the wound bed (infection, Inflammation) earlier than the regularly performed clinical assessment.
Part 2: The aim of this part of the study was to evaluate (I) the possibility of wound fluid acquisition by means of an "additional collector" during ongoing NPWT and to answer if (II) this secretion can be biochemically analyzed for enzyme activities in order to be able to detect a change in the wound situation at an early stage.
详细描述
The study is composed of two parts, which run independently of each other. However, in both parts the course of the wounds is analyzed.
Part 1: Two wound swabs are taken. One used for routinely performed microbiological analysis and the second will be used for biochemical analysis (enzyme activities). The aim of the wound swabs is to answer the question whether the rapid diagnostic tool used in the examination can display an infection prematurely or not. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) would indicate a change in the wound bed (infection, inflammation) earlier than the regular clinical assessment. These wound swabs are expected to function as an improvement of the biochemical assays or rather of the technology concerning sensitivity and specificity of, for example, the pH number, the MPO, the LYS, the gelatinase and the elastase. In addition to that, the correlation between the Enzyme activities and the course of the infection will be examined. This technology is supposed to be later used as an early infection diagnostic tool in wound fluids. The followup of this testing system is a crucial prerequisite for the application of the technology in VAC therapy (part 2).
Part 2: The findings of this examination will be used to investigate the applicability of the developed in-vitro early infection diagnostic tool in negative-pressure therapy (VAC therapy; vacuum assisted closure).
Patients of the plastic surgery with a NPWT are included in this prospective study. Before the NPWT will be applied, two swabs (biochemical and microbiological analysis) of the wounds will be taken. After installation of the dressing, the connecting tube between the wound and the vacuum-generating device will be cut and an "additional collector" will be inserted. This collector will be changed daily and afterwards the concentrations of enzymes (lysozyme, elastase, myeloperoxidase) will be biochemically analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •signed informed consent
- •older than 18 years old
- •open wound of varying etiology
- •VAC therapy (KCI) (part 2)
排除标准
- •under 18 years old
- •pregnant women
- •less than three measurement data (less than three swabs) = part 1
- •VAC-instill therapy = part 2
结局指标
主要结局
Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing negative pressure wound therapy
时间窗: during negative pressure wound therapy
The aim is to answer the question if it is feasible to collect wound fluid during ongoing negative pressure wound therapy and analyze this wound fluid biochemically.
Part 1: biochemical analysis of wounds
时间窗: during hospitalization
Elevated enzyme activities (biochemical analysis of wound swabs) give information of the condition of the wound bed (infection, inflammation).
次要结局
- Part 2: Evaluating changes in enzyme activities in the collected wound fluid(Starting immediately after installation of the negative-pressure dressing and lasting for 3 days.)
研究者
Christina Helene Wolfsberger
Sub-Investigator
Medical University of Graz