ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
This study is investigating a new treatment called ConvaVAC™ Ag+. It's a special type of wound therapy designed to help heal chronic wounds, specifically focusing on Venous Leg Ulcers (VLUs). These are wounds that take a long time to heal and can be painful and impact daily life. VLUs are quite common, affecting about 1 in 100 people. Regular treatments involve cleaning, special dressings, and pressure. This study wants to see if the ConvaVAC™ Ag+ system can make a real difference, helping these wounds heal more quickly and safely than current methods. The goal is to understand if this new system is both effective and safe for people with these challenging leg ulcers.
At a glance
What is this study about?
You might have a type of wound that doesn't heal easily, called a chronic wound. These wounds can be frustrating and sometimes painful, making everyday tasks harder. They also use up a lot of time and resources for healthcare professionals. One common type of chronic wound is a Venous Leg Ulcer (VLU), which happens when the veins in your legs don’t work as well as they should, leading to wounds that struggle to close.
Often, these hard-to-heal wounds can become infected. This isn't always obvious but can slow down healing even more. Tiny communities of germs, called biofilms, can grow in wounds and protect themselves from medicines like antibiotics, making them much harder to treat. You might be familiar with silver in some wound dressings; this is because silver can help fight off these germs and might even help break down biofilms, giving the wound a better chance to heal.
This study is looking at a new wound therapy system called ConvaVAC™ Ag+. This system combines a special type of wound dressing with negative pressure (meaning it creates a gentle suction) and uses silver to help fight infection. Researchers want to find out if this combination can effectively and safely help Venous Leg Ulcers heal better than current treatments. By understanding how well it works and if it's safe, they hope to improve care for people with these specific leg wounds.
Key takeaways
- This study evaluates a new wound therapy for long-lasting leg ulcers (VLUs).
- The therapy, ConvaVAC™ Ag+, combines gentle suction with silver for healing.
- It aims to improve healing and safety for challenging chronic wounds.
- Participation involves regular clinic visits for wound care and checks.
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
To be part of this study, you need to be aged 18 or over. The study is specifically looking for people with a Venous Leg Ulcer (VLU) that doctors believe could benefit from this type of negative pressure wound therapy with silver. Your wound should be generally clean or just slightly contaminated, and your doctor should think that an antimicrobial dressing (like one with silver) would be helpful.
There are also some reasons why you might not be able to join. For example, if you're allergic to any part of the ConvaVAC™ Ag+ system, or if your wound has certain types of dead tissue that need special removal. You also can't have very small or very large wounds, or wounds deeper than 7cm. Your doctor will carefully check these details.
Other reasons for not being able to join include having certain medical conditions like active cancer in the wound area, exposed bones, blood vessels or nerves in the wound, or severe whole-body infections. If you're pregnant, receiving certain cancer treatments, or if your doctor doesn't think the study is right for you for other safety reasons, you wouldn't be able to participate. The study aims to make sure it's safe for everyone involved.
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?
- Do you have a Venous Leg Ulcer (VLU) that your doctor thinks might benefit?
- Do you have any known allergies to wound dressings or silver?
- Is your wound free from certain types of dead tissue or exposed bone?
- Are you currently pregnant or undergoing certain cancer treatments?
What does participation involve?
If you decide to take part in this study, you'll be using the ConvaVAC™ Ag+ wound therapy system on your leg ulcer. This will involve regular changes of the dressing and visits to the clinic or hospital to have your wound checked by the study team. They will monitor how your wound is healing, assess any pain or discomfort, and make sure the treatment is working as expected. You'll also likely be asked questions about how you feel your wound is affecting your daily life. The total duration of your participation will depend on how your wound heals, but the study team will explain the expected timeframe during your initial discussion. You won't be given any new medications to take by mouth specifically for the study. The focus is on the wound therapy system itself.
Potential risks and benefits
Locations (7)
- ConvaCare ClinicVerified postcodeSantiago, Chile· Recruiting
- Middlewood PartnershipVerified postcodeBollington, United Kingdom· Recruiting
- Knutsford Medical PartnershipVerified postcodeKnutsford, United Kingdom· Recruiting
- Dorset County Hospital NHS Foundation TrustVerified postcodeDorchester, United Kingdom· Recruiting
- Assured Clinical Research LtdVerified postcodeSwaffham, United Kingdom· Recruiting
- Northumbria Healthcare NHS Foundation TrustVerified postcodeAshington, United Kingdom· Recruiting
- Nottingham University Hospitals NHS TrustVerified postcodeNottingham, United Kingdom· Recruiting
Common questions
What is a Venous Leg Ulcer (VLU)?
It's a long-lasting wound on the leg caused by problems with blood flow in the veins, making it hard for the wound to heal properly.
What is ConvaVAC™ Ag+?
It's a special wound therapy system that uses gentle suction (negative pressure) and silver in the dressing to help chronic wounds heal and fight infection.
Why is this study important?
It aims to find out if this new therapy can help people with Venous Leg Ulcers heal faster and more safely, potentially improving their quality of life.
Will I have to pay to be in the study?
No, you will not have to pay for the study treatment or assessments. This is usually covered by the study organisers.
What if the treatment doesn't work for me?
If the treatment isn't working or causes problems, the study team will discuss alternative care options with you, and you can withdraw from the study at any time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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