Statseal® for Central Venous Catheter Insertion Sites in Critical Care

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

Interventions

OTHER

A haemostatic mineral powder product.

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.

Sponsors & Collaborators

• Biolife LLC

  collaborator UNKNOWN

• Liverpool Heart and Chest Hospital NHS Foundation Trust

  lead OTHER

Principal Investigators

• Rodney H Stables, MA DM BM BCh FRGS · Liverpool Heart and Chest Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-14

Primary Completion

2025-09-19

Completion

2025-11-30

Countries

• United Kingdom

Study Locations