Statseal® for Central Venous Catheter Insertion Sites in Critical Care (NCT06451185) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Statseal® for Central Venous Catheter Insertion Sites in Critical Care
United Kingdom450 participantsStarted 2024-10-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to first unplanned change of the index dressing.
Timeframe: Seven days
Trial details
NCT IDNCT06451185
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust