Statseal® for Central Venous Catheter Insertion Sites in Critical Care

NCT06451185 | Active Not Recruiting

• 1 other identifier: 338511
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Line; Central Venous Catheter; Vascular Access; Critical Care; Hemostatic

Keywords

Adaptive; Randomized Controlled Trial; Low-intervention; Low-risk; Open Label; Pragmatic

Outcome Measures

Primary Outcomes (1)

• Time to first unplanned change of the index dressing.

  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.

  Seven days

Secondary Outcomes (4)

• Reason(s) for an unplanned change of the index dressing

  Seven days

• Proportion of index dressings that required an unplanned change

  Seven days

• Skin status at dressing removal

  Seven days

• Incidence of bleeding

  Seven days

Study Arms (2)

Standard Care Group

NO INTERVENTION

Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a standard care transparent dressing.

Haemostatic Powder Group

EXPERIMENTAL

Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a haemostatic powder product beneath the standard care transparent dressing.

Other: A haemostatic mineral powder product.

Interventions

A haemostatic mineral powder product. OTHER

The intervention is the addition of an approved and commercially available haemostatic powder product which is indicated for the temporary external control of bleeding. Recommended application is at central venous catheter 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 site dressings.

Haemostatic Powder Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Biolife LLC: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital NHS FoundationTrust

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Study Officials

• Rodney H Stables, MA DM BM BCh FRGS

  Liverpool Heart and Chest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centre, prospective, open label, randomised, controlled, adaptive investigation.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: October 14, 2024
• Primary Completion: September 19, 2025
• Study Completion: November 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: For up to 24 months following publication.
• Access Criteria: Prospective researchers should contact the Sponsor with details of their analysis plan and an assertion that they commit to open publication of their findings. Data will be provided without investigator support.

Locations

GB (1)