Active not recruitingNAINTERVENTIONAL

Statseal® for Central Venous Catheter Insertion Sites in Critical Care

This study is about making central lines safer and more comfortable. A central line is a tube doctors put into a large vein, often in the neck, during surgery in critically ill patients. Usually, these lines are stitched in place and covered with a clear dressing. This study compares that standard care with a new approach: adding a special powder, called Statseal®, underneath the clear dressing. This powder is designed to help blood clot at the skin, reduce bleeding, and keep the area dry. By keeping the area dry and preventing bleeding, we hope the dressings will stay on better and reduce the risk of problems like infections. We'll be looking at how long the dressings last, why any might need changing unexpectedly, and if there's any bleeding or skin issues.

At a glance

Status

Active not recruiting

Phase

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Enrolment target

450

Start

14 Oct 2024

Estimated completion

30 Nov 2025

Central Line Central Venous Catheter Vascular Access Critical Care Hemostatic

What is this study about?

When you're very poorly, especially after surgery, doctors might need to put a special tube called a central line into a large vein, often in your neck. This is a common and important procedure. These lines are used to give you medicines or fluids directly into your bloodstream. Once the line is in, it's secured and covered with a clear dressing to keep it clean and protected. This dressing usually stays on for up to seven days.

Sometimes, the area around the central line can get a bit moist or bleed a little. This can happen, especially if you've had heart surgery, as some medications given might increase your risk of bleeding. If the dressing gets wet or bloody, it might not stick properly, or it could create a warm, damp environment that might increase the risk of infection. If a dressing loosens or gets dirty, nurses might need to change it more often than planned, which takes time and could be a bit uncomfortable for you.

This study is looking at a new way to keep the area around your central line drier and reduce bleeding. We're testing a special powder, called Statseal®, which is put on the skin before the usual clear dressing goes on. This powder helps blood clot at the skin's surface and absorbs any moisture. The idea is that by keeping the area dry and preventing bleeding, the dressing will stay on better, for longer, and hopefully reduce the risk of any problems. We want to see if this new approach makes a real difference for patients.

Key takeaways

A study testing a new powder for central line dressings.
Aims to reduce bleeding and keep the dressing site dry.
Participation lasts up to seven days, during the first dressing.
No extra visits or changes to your routine medical care.
Compares standard dressing to dressing with added powder.
Might help improve central line care for future patients.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) who is having surgery in a specialist heart and lung hospital. As part of your treatment, you would need to be having a central line placed into a large vein in your neck, which is a common procedure for many patients undergoing this type of surgery.

There are certain situations where you wouldn't be able to join the study. For example, if you already have, or are planning to have, more than one central line inserted into the same side of your neck. Also, if the skin where the central line will go is already damaged or unhealthy, you wouldn't be able to participate. If there's a chance you might be moved to a different hospital within a week of your central line being put in, you wouldn't be eligible either.

During surgery, if the central line insertion isn't straightforward, or if you have a known allergy to the dressings or powder used in the study, you wouldn't be able to take part. Also, if the central line has a special tunnel under the skin, or if the dressing can't be applied properly to cover the area, then you wouldn't be included. The study team will check all these things carefully to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having surgery and a central line placed in your neck as part of your care?
Do you have healthy skin where the central line will be inserted?
Do you expect to stay at the same hospital for at least 7 days after your central line is placed?
Do you only plan to have one central line on one side of your neck?

Answer every question to see your result.

What does participation involve?

If you are part of this study, you won't need to do anything extra beyond your usual care. The central line will be placed as planned during your surgery. For some participants, a special powder will be used under the regular dressing. For others, just the regular dressing will be used. Which one you receive will be decided by chance, like flipping a coin.

Once the dressing is applied, the nurses will continue to monitor your central line site as part of their routine checks. They will be looking to see how well the dressing stays on, if there's any bleeding, or if any skin issues develop. You won't have any extra visits to the hospital or clinic because of this study. The study looks at how the very first dressing performs. Once that first dressing is removed (which usually happens within seven days as part of your normal care), your participation in the study ends, and all your care continues as usual. Your overall treatment will not be affected by being in the study.

Potential risks and benefits

Taking part in this study means we might learn how to make central lines more secure and comfortable for future patients, potentially reducing risks of complications like dressing issues or infections. The powder being tested is already approved for use. For you, there are no expected direct medical benefits as your core treatment remains the same, but you might find your dressing stays more secure or causes less irritation if you receive the powder. There are usually no extra risks beyond those associated with your routine central line care. You can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Liverpool Heart and Chest Hospital NHS FoundationTrust
Verified postcode
Liverpool, United Kingdom

Common questions

What is a central line?

A central line is a thin tube doctors place into a large vein, often in the neck or chest, to give medicines or fluids directly into your bloodstream, especially in seriously ill patients.

What is Statseal®?

Statseal® is a special mineral powder designed to help stop small bleeds and absorb moisture at the skin surface where a central line is inserted.

Will I know if I get the powder or not?

No, you won't know if you receive the powder or just the standard dressing. This is decided by chance to ensure fair results for the study.

How long will I be in the study?

Your participation in the study lasts as long as your first central line dressing is in place, usually up to seven days. After it's removed, your part in the study is over.

Will this study change my medical treatment?

No, the study does not change your overall medical treatment. It only looks at the type of dressing used on your central line insertion site.