Critical Care Clinical Trial
— SCENICOfficial title:
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
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.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 24, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool Heart and Chest Hospital NHS FoundationTrust | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool Heart and Chest Hospital NHS Foundation Trust | Biolife LLC |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Reason(s) for an unplanned change of the index dressing | The reason(s) for an unplanned change of the index dressing | Seven days | |
Secondary | Proportion of index dressings that required an unplanned change | The proportion of index dressings that require an unplanned change in the period from randomisation to planned CVC removal or routinely scheduled dressing change | Seven days | |
Secondary | Skin status at dressing removal | Skin status at index dressing removal, defined as: erythema only, limited to = 1.5cm of the CVC insertion site, and when extending >1.5cm up to and beyond the adhesive border of the transparent dressing and clinically assessed to be dressing-related. Evidence of mechanical skin injury suggested by rips or tears, with or without erythema extending up to 1.5cm beyond the adhesive border of the transparent dressing. Evidence of other skin disruption with or without erythema such as blisters or maceration within the same extended area of up to 1.5cm | Seven days | |
Secondary | Incidence of bleeding | The incidence of CVC insertion site related bleeding observed beneath the transparent portion of the dressing. As is best practice and standard care, all will prompt dressing change. Trial definition of bleeding: Grade 1 - dry blood observed in the vicinity of the puncture site, change of dressing (with usual site cleansing) being the only actions required. Note: blood that has formed a desiccated complex with the haemostatic powder is not considered contamination. Grade 2 - overt but minor bleeding requiring minimal bedside action(s) such as manual compression or application of wound adhesive. Grade 3 - continuous or significant overt bleeding requiring timely investigation such as ultrasound or radiological assessment, with action(s) informed by findings. Grade 4 - continuous or significant overt bleeding requiring urgent or emergency action | Seven days |
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