STIMULAN, botulinum toxin A, their combination, or standard surgery alone for Hidradenitis Suppurativa: a 4-arm design PROBE (prospective randomised open-label blinded-endpoint) trial
Hidradenitis suppurativa (HS), more specifically HS Hurley stages II and III.
Study arm 1. Surgery alone (control group) Participants allocated to this group will undergo standard NHS care for advanced hidradenitis suppurativa. This consists of wide local surgical excision of the affected area. Wound closure will be carried out using direct closure, a skin graft, or a local flap. The method of closure will be decided by the consultant surgeon based on defect size, location, tissue availability, and clinical judgement. The surgery is performed once as an open procedure and typically lasts between 60 minutes and 180 minutes. No additional study treatments are given. Participants will be followed up at 2 weeks, 3 months, 6 months, and 1 year after surgery. Study arm 2. Surgery plus botulinum toxin A Participants in this group will receive a single session of botulinum toxin A injections approximately 2 weeks before surgery. The injections are given under the skin in a grid pattern to the affected area. Doses vary by anatomical site, with typical doses of 50 to 150 units per side for the armpit and up to 200 units per side for the groin. Following this, participants will undergo the same wide local excision surgery as described in study arm 1. The injection session lasts up to 30 minutes and surgery is performed once. Follow-up visits are the same as for all other study arms, at 2 weeks, 3 months, 6 months, and 1 year post-operatively. Study arm 3. Surgery plus STIMULAN antibiotic beads Participants allocated to this arm will undergo wide local excision surgery as per standard care. During surgery, absorbable STIMULAN antibiotic beads will be placed directly into the surgical site before wound closure. The beads are prepared using calcium sulfate mixed with antibiotics, either vancomycin 1 gram with gentamicin 240 milligrams or vancomycin 1 gram with tobramycin 240 milligrams, depending on local bacterial patterns. Placement of the beads adds up to 10 minutes to the procedure. The beads dissolve naturally and do not require remova
1. Patient must have HS 2. Patient must be above 18 years of age 3. Patient must be below 65 years of age 4. Patient must be in Hurley stages II or III 5. Patient must be suitable for wide excision surgery 6. Patient’s disease must be amenable to treatment in the groin, axilla, and perineal regions 7. Patient must have at least one region with active disease 8. Patient must consent to be a part of the study (including the follow-ups)
1. Candidates responsive to medical therapy 2. Children and the elderly (<18 and 65<) 3. Known hypersensitivities/allergies to study interventions 4. Active systemic infection prior to surgery 5. Pregnant or breastfeeding 6. Immunosuppressed 7. Participation in another interventional trial within 90 days