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Completed
NCT06451185
Statseal® for Central Venous Catheter Insertion Sites in Critical Care
Conditions: Central Line, Central Venous Catheter, Vascular Access, Critical Care, Hemostatic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 451
Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Location: Liverpool Heart and Chest Hospital NHS FoundationTrust Liverpool Merseyside
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT06451185). StuddyBuddy aggregates publicly available trial information.