Central LineSCENICNCT06451185
Statseal® for Central Venous Catheter Insertion Sites in Critical Care
A study testing A haemostatic mineral powder product. in people with Central Line and Central Venous Catheter, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Line, Central Venous Catheter, Vascular Access
- What is being tested?
- A haemostatic mineral powder product.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital NHS FoundationTrust
Liverpool, Merseyside, L14 3PE
About this study
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
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.
Read more
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.
Read the 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:
- Current standard care group - where the site is covered with a transparent dressing.
- 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.
- Being tested
- A haemostatic mineral powder product.
- Keywords
- Adaptive, Randomized Controlled Trial, Low-intervention, Low-risk, Open Label, Pragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A haemostatic mineral powder product.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a standard care transparent dressing. |
| Haemostatic Powder Group | Experimental | Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a haemostatic powder product beneath the standard care transparent dressing. Receives: Other: A haemostatic mineral powder product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven days
Secondary outcomes (4)
Reason(s) for an unplanned change of the index dressing
The reason(s) for an unplanned change of the index dressing
Measured: Seven days
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
Measured: Seven days
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
Measured: Seven days
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
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start14 Oct 2024
- Primary completion19 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central LineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single centre, prospective, open label, randomised, controlled, adaptive investigation.
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Biolife LLC
- Responsible party
- Sponsor
- Investigators
- Rodney H Stables, MA DM BM BCh FRGS, Study director, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451185
- Sponsor's protocol ID
- 338511
- Acronym
- SCENIC
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results at publication will be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06451185
- Acronym / sponsor ID
- SCENIC / 338511
- Keywords
- Adaptive, Randomized Controlled Trial, Low-intervention, Low-risk, Open Label, Pragmatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Biolife LLC
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Current standard care group - where the site is covered with a transparent dressing.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single centre, prospective, open label, randomised, controlled, adaptive investigation.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a standard care transparent dressing. |
| Haemostatic Powder Group | Experimental | Other: A haemostatic mineral powder product.Following successful insertion of a central venous catheter into an internal jugular vein, the site will be covered with a haemostatic powder product beneath the standard care transparent dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Haemostatic Powder Group |
Primary outcome
Time to first unplanned change of the index dressing.
Time frame: Seven days
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.
4 secondary outcomes
Reason(s) for an unplanned change of the index dressing
Time frame: Seven days
Proportion of index dressings that required an unplanned change
Time frame: Seven days
Skin status at dressing removal
Time frame: Seven days
Incidence of bleeding
Time frame: Seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results at publication will be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney H Stables, MA DM BM BCh FRGS study director
Liverpool Heart and Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A haemostatic mineral powder product. in people with Central Line and Central Venous Catheter, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first unplanned change of the index dressing. (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.