Hidradenitis suppurativa (HS), more specifically HS Hurley stages II and III. Skin and Connective Tissue Diseases
Conditions
Interventions
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
Sponsors
STIMULAN (Biocomposites Ltd)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HS recurrence measured using expert opinion, patient opinion, and Hurley staging. Any HS symptoms experienced by the patients at up to 1 year post-operatively;Wound Healing measured using TIME: devitalized tissue removal (T), infection and inflammation control (I), moisture imbalance (M), and advancement of the epithelial edge of the wound (E) at up to 6 months post-operatively.;Pain Score measured using patient opinion and the pain scale at up to 1 year post-operatively;Wound dehiscence rate measured using patient reports at up to 1 year post-operatively;Aesthetic outcome measured using questionnaire and blinded expert opinion at up to 1 year post-operatively;HiSCR measured using blinded expert opinion and patient opinion at up to 1 year post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured using dermatology life quality index (DLQI) at up to 1 year post-operatively | — |
Countries
England, United Kingdom
Contacts
Public ContactParia Maghsoodlou
Outcome results
None listed