An Adaptive Randomised Controlled Trial, Performed in a Cardiothoracic Theatre and Critical Care Setting, to Investigate the Integrity and Durability of Standard Care Dressings Compared With Use of an Additional Haemostatic Powder, to Cover and Protect Central Venous Catheter Insertion Sites
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to first unplanned change of the index dressing.
研究概览
简要总结
All participants in this clinical trial will be undergoing surgery and will have a central venous catheter (also known as a central line) placed in the large vein in the neck as part of their routine care.
The purpose of this clinical trial is to compare different ways of dressing central lines. In current standard care, central lines are stitched in place and covered with a protective transparent dressing. This standard care will be compared with the addition of a haemostatic powder beneath the transparent dressing. This powder product aids clotting at the level of the skin, meaning that it prevents or reduces bleeding while helping to maintain a dry and protected environment.
The main questions this clinical trial aims to answer are:
- Will the addition of a haemostatic powder increase the durability of central line dressings?
- What proportion of dressings required an unplanned change?
- The reason(s) for any unplanned change
- The incidence of bleeding around central line insertion sites
- Were any skin problems observed once the dressings were removed?
Once the dressings are applied, all central lines sites will be monitored as part of the participant's routine care. Participation in the clinical trial lasts as long as the first central line dressing remains in place. Central line dressings currently and routinely remain in place for up to, but not more than seven days. After this period, there will be no need for any research-related observations. Routine care will continue and will not be affected by the research. Participants will not be asked to make any extra visits over and above those needed for routine care.
详细描述
Current established practice recommends that central venous catheter (CVC) dressings that are clean dry and intact can safely remain in place for up to seven days. Bleeding and moisture at CVC insertion sites can lead to poor dressing adherence and to an environment favourable for microbial growth. Additional unplanned interactions are provoked such as undressing, cleaning and redressing the site; in some circumstances it may be necessary to change or to re-site the catheter. Each of these factors may increase the risk of infection while consuming additional healthcare time and resource.
The study will recruit patients undergoing surgery in a tertiary cardiothoracic hospital. Those selected will have planned CVC insertion. The majority of patients will have an increased bleeding risk due to the nature of cardiac surgery, usually requiring a number of agents to reduce their risk of thrombosis. Whilst there is a suitably individualised and patient-specific assessment of risk, the internal jugular is the preferred vein for a large proportion of our patients.
Haemostasis is the mechanism by which bleeding is stopped by the formation of a clot. In anticoagulated patients, clot formation is prolonged resulting in frequent oozing and bleeding around CVC insertion sites and to the soiling of dressings. Serous exudate, clammy skin and diaphoresis present additional challenges in this patient cohort. StatSeal® is an approved and commercially available haemostatic powder product indicated for the temporary external control of bleeding. Recommended application is at CVC insertion, prior to the site being covered with a transparent dressing. Comprising a hydrophilic polymer and potassium ferrate, once in contact with protein-rich body fluids, the mechanism of action of the powder is to dehydrate and to absorb exudate. This simultaneously forms a low pH seal barrier which is hostile to microbial penetration while also purporting to help maintain clean and dry environment beneath transparent dressings.
The objective of the study is to compare current standard care with use of an additional haemostatic powder.
Following the successful insertion of an internal jugular CVC in the theatre area, participants will be randomised in a 1:1 ratio into one of the following groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Pre-Theatre Phase - Scheduled for insertion of an internal jugular CVC as part of their routine care
- •Theatre Phase
- •- Successful insertion of an internal jugular CVC
排除标准
- •Pre-Theatre phase
- •Patients younger than 18 years of age
- •Patients scheduled cannulation with more than one sheath or catheter into an ipsilateral internal jugular vein
- •Patients with compromised skin integrity in the area to be covered with the CVC transparent dressing
- •Patients who are scheduled to be transferred to another hospital at any time during the trial observation period of seven days post randomisation
- •Theatre phase
- •Randomisation system not available
- •Known allergy to study dressings
- •Trial dressings not available
- •Skin barrier product not available
- •Securement suture not practicable
- •The CVC insertion site cannot be covered with either a single conventional dressing or the haemostatic powder covered with a single transparent dressing
- •Central line has a subcutaneous tunnel
- •More than one ipsilateral central venous sheath or catheter in situ (or planned)
结局指标
主要结局
Time to first unplanned change of the index dressing.
时间窗: Seven days
Time to first unplanned change of the index dressing (measured in hours) from randomisation, or CVC removal (at any time) or planned index dressing removal (at seven days) - whichever is soonest.
次要结局
- Proportion of index dressings that required an unplanned change(Seven days)
- Reason(s) for an unplanned change of the index dressing(Seven days)
- Skin status at dressing removal(Seven days)
- Incidence of bleeding(Seven days)