Clinical Trial

Statseal® for Central Venous Catheter Insertion Sites in Critical Care

Study acronym: SCENIC
Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-05; most recent amendment 2025-09-22.
Status change: Recruiting → Active, Not Recruiting 2025-09-22
Status change: Not Yet Recruiting → Recruiting 2025-03-10
Trial Details
NCT Number NCT06451185
Lead Sponsor Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators: Biolife LLC
Conditions Central Line, Central Venous Catheter, Vascular Access, Critical Care, Hemostatic
Enrollment 450 participants
Start Date 2024-10-14
Primary Completion 2025-09-19 (estimated)
Study Completion 2025-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-25