Statseal® for Central Venous Catheter Insertion Sites in Critical Care

Launched by LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different types of dressings used for central venous catheters (CVC) affect the care of patients in critical care settings. A central venous catheter is a tube placed in a large vein in the neck to help with treatment. The trial compares the regular method of covering these catheters with a special dressing that includes a powder designed to help stop bleeding and keep the area dry. Researchers want to find out if this powder makes the dressings last longer, if it reduces the need for changing dressings unexpectedly, and if it causes any skin problems.

To join the trial, participants need to be scheduled for a CVC insertion as part of their routine medical care and be between the ages of 18 and 74. They will not have to make extra visits; their regular care will continue as usual during the study, which lasts up to seven days while the dressing is in place. If you or a family member is eligible, you can expect to have your CVC dressing monitored closely, but you won’t have to do anything different from your regular treatment.

Gender

ALL

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)