Comparing dressing methods for central venous catheters in critical care patients
An Adaptive Randomised Controlled Trial, Performed in a Cardiothoracic Theatre and Critical Care Setting, to Investigate the Integrity and Durability of Standard Care Dressings Compared With Use of an Additional Haemostatic Powder, to Cover and Protect Central Venous Catheter Insertion Sites
This study is testing if using a special powder with dressings for central venous catheters can help prevent bleeding and keep the dressings on better for patients in critical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liverpool Heart and Chest Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT06451185 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a haemostatic powder in enhancing the durability of dressings for central venous catheters (CVCs) in patients undergoing surgery. Participants will have a CVC inserted as part of their routine care, and the study will compare standard dressing methods with those that include the haemostatic powder. The trial will assess factors such as the incidence of bleeding, the need for unplanned dressing changes, and the overall adherence of the dressings over a seven-day observation period. The goal is to improve patient outcomes by reducing complications associated with CVC insertion sites.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for internal jugular CVC insertion as part of their surgical care.
Not a fit: Patients under 18 years old or those with compromised skin integrity at the insertion site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer complications and infections related to central venous catheters, improving patient safety and recovery.
How similar studies have performed: While similar approaches have been explored, this specific use of haemostatic powder in CVC dressing is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Liverpool, Merseyside
- Liverpool Heart and Chest Hospital NHS FoundationTrust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Christine Mars, BSc
- Email: christine.mars2@lhch.nhs.uk
- Phone: +44 151 600 1616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.