Clinical trial NCT06451185: Statseal® for Central Venous Catheter Insertion Sites in Critical Care
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Line
Central Venous Catheter
Vascular Access
Critical Care
Hemostatic
Keywords: Adaptive
Randomized Controlled Trial
Low-intervention
Low-risk
Open Label
Pragmatic
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Biolife LLC
First posted: 2024-06-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single centre, prospective, open label, randomised, controlled, adaptive investigation.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Current established practice recommends that central venous catheter (CVC) dressings that are clean dry and intact can safely remain in place for up to seven days. Bleeding and moisture at CVC insertion sites can lead to poor dressing adherence and to an environment favourable for microbial growth. Additional unplanned interactions are provoked such as undressing, cleaning and redressing the site; in some circumstances it may be necessary to change or to re-site the catheter. Each of these factors may increase the risk of infection while consuming additional healthcare time and resource.

The study will recruit patients undergoing surgery in a tertiary cardiothoracic hospital. Those selected will have planned CVC insertion. The majority of patients will have an increased bleeding risk due to the nature of cardiac surgery, usually requiring a number of agents to reduce their risk of thrombosis. Whilst there is a suitably individualised and patient-specific assessment of risk, the internal jugular is the preferred vein for a large proportion of our patients.

Haemostasis is the mechanism by which bleeding is stopped by the formation of a clot. In anticoagulated patients, clot formation is prolonged resulting in frequent oozing and bleeding around CVC insertion sites and to the soiling of dressings. Serous exudate, clammy skin and diaphoresis present additional challenges in this patient cohort. StatSeal® is an approved and commercially available haemostatic powder product indicated for the temporary external control of bleeding. Recommended application is at CVC 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 dressings.

The objective of the study is to compare current standard care with use of an additional haemostatic powder.

Following the successful insertion of an internal jugular CVC in the theatre area, participants will be randomised in a 1:1 ratio into one of the following groups:

1. Current standard care group - where the site is covered with a transparent dressing.
2. Intervention group - where the powder will be applied around the CVC skin insertion site before being covered with the same transparent dressing.

This is a low-intervention, low-risk pragmatic study. The consent seeking process is proportionate and adapted to the design of the study.

Routine monitoring of each CVC site will follow. Each CVC insertion site will be observed from randomisation for a period of 168 hours (seven days) or up to the time of CVC removal or first dressing change (which ever event occurs soonest). The 7-day period has been selected as this would be the time of the first planned dressing change for the CVC placed at randomisation. Within this period, data will be collected to investigate the duration and integrity of each index dressing including the reasons for removal and, the skin status at removal.

Data collection will be electronic and will be performed by medical, nursing and other suitably qualified and trained staff thus facilitating multidisciplinary collaboration and integration of research with everyday clinical practice.

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)

Primary outcomes:
measure: Time to first unplanned change of the index dressing.
timeFrame: Seven days
Secondary outcomes:
measure: Reason(s) for an unplanned change of the index dressing
timeFrame: Seven days
measure: Proportion of index dressings that required an unplanned change
timeFrame: Seven days
measure: Skin status at dressing removal
timeFrame: Seven days
measure: Incidence of bleeding
timeFrame: Seven days
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS FoundationTrust
state: Merseyside
Study officials:
affiliation: Liverpool Heart and Chest Hospital
name: Rodney H Stables, MA DM BM BCh FRGS
role: STUDY_DIRECTOR
References: