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Statseal® for Central Venous Catheter Insertion Sites in Critical Care

Study acronym: SCENIC
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Enrollment target: estimated 450 to confirmed 451
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 2 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Oct 31, 2025 to Sep 19, 2025
    • Site details revised
    v4
  3. Minor Primary completion date: Aug 31, 2025 to Oct 31, 2025
    • Study completion date: Aug 31, 2025 to Nov 30, 2025
    • Start date changed from estimate of Aug 31, 2025 to Oct 14, 2024
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 24, 2024 to Aug 31, 2025
    • Start date: Jun 12, 2024 to Aug 31, 2025
    • Study completion date: Dec 31, 2024 to Aug 31, 2025
    • Site details revised
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06451185
Lead Sponsor Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators: Biolife LLC
Conditions
(from sponsor)
Central Line, Central Venous Catheter, Vascular Access, Critical Care, Hemostatic
Enrollment 451 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov