Testing different treatment options for Hidradenitis Suppurativa: antibiotic beads, botulinum injections, combination therapy, or standard surgery
Hidradenitis suppurativa (HS) is a painful, long-term skin condition causing lumps, boils, and scarring in areas like the armpits and groin. Surgery to remove affected skin is common for severe cases, but the condition returns in more than one in four patients. Researchers at the Royal London Hospital are running a study to find out if extra treatments during surgery can stop HS from returning. Adults aged 18 to 64 needing surgery for moderate-to-severe HS will be randomly placed into one of four groups: standard surgery alone, surgery with antibiotic beads (STIMULAN), surgery with botox injections, or surgery with both added treatments. The research team will track healing, pain levels, and whether lumps return during regular check-ups over one year. The findings could help improve future surgical care across the NHS.
Em resumo
Sobre o que é este estudo?
Hidradenitis suppurativa (HS) is a painful, long-term condition that affects the skin, most commonly where skin rubs together, such as the armpits, groin, and bottom. It causes tender lumps, recurrent boils, and deep scarring. When medicines like tablets or creams no longer control the disease, surgery to remove the affected skin is often the next step.
While surgery can offer relief, HS comes back after an operation in up to 27 percent of people—more than one in four. Healing from this type of surgery can also take time, and there is always a risk of wound infections or slow recovery. Finding ways to protect wounds and stop the condition from flaring up again is an important goal for doctors.
This trial compares four surgical approaches to see which gives the best results. Patients will receive standard NHS surgery, either on its own or alongside one or two extra treatments: antibiotic beads (called STIMULAN) placed in the wound to fight bacteria, or botulinum toxin A (botox) injections to help calm the area and aid healing. By comparing these options, researchers hope to discover how to give patients longer-lasting relief and better healing.
Pontos principais
- Tests whether antibiotic beads, botox, or both can improve standard surgery for HS.
- Open to adults aged 18 to 64 with moderate to severe HS in the armpits, groin, or bottom.
- Everyone in the trial receives standard NHS surgery to remove affected skin.
- Follow-up appointments take place over 12 months to monitor wound healing and flare-ups.
- Joining is completely voluntary and will not affect your standard NHS treatment.
Quem pode ser elegível?
This trial is for adults aged 18 to 64 who have moderate to severe hidradenitis suppurativa (known medically as Hurley stage II or III). You must have active lumps or boils in your armpits, groin, or around your genitals and bottom that are suitable for surgical removal.
The study is not suitable for people whose symptoms are well managed with medicines alone. You will not be able to join if you are under 18 or 65 and older, pregnant, breastfeeding, or have a weakened immune system.
You also cannot take part if you have a known allergy to botox or the antibiotic beads, currently have a widespread infection, or have taken part in another clinical trial within the past 90 days.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- I am aged between 18 and 64.
- I have moderate to severe HS (Hurley stage II or III).
- My HS affects my armpits, groin, or bottom area.
- My doctor has suggested surgery to remove the affected skin.
- I am not pregnant or breastfeeding.
- I do not have a weakened immune system.
O que envolve a participação?
If you agree to take part, you will first have a screening visit to make sure the trial is safe and right for you. All participants receive standard NHS surgery to cut away the affected skin. A computer will randomly assign you to one of four groups: surgery alone, surgery with antibiotic beads, surgery with botox injections, or surgery with both treatments. You cannot choose your group. After surgery, you will attend hospital check-ups at 2 weeks, 3 months, 6 months, and 1 year. At each visit, doctors will examine your healing, check for any new lumps, and ask how you are feeling. Your total time in the study will be about one year.
Riscos e benefícios potenciais
Localizações (1)
- Barts Health NHS TrustApenas cidadeLondon, England
Perguntas frequentes
Do I have to pay to take part?
No. All operations, appointments, and study treatments are provided free of charge through the NHS.
Can I pick which treatment I receive?
No. A computer randomly allocates you to one of the four groups to ensure the study results are fair and unbiased.
Will I definitely still have surgery?
Yes. Every person who takes part in the study receives standard NHS surgery to remove the affected skin.
Where does the study take place?
The trial is based in the Plastics Department at the Royal London Hospital in London.
What happens if my HS flares up during the trial?
Your hospital team will examine you and provide standard NHS care to treat the flare-up and keep you comfortable.
Como saber mais
Paria Maghsoodlou
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
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Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.