Perforator Flaps for Axillary Hidradenitis Suppurativa
France88 participantsStarted 2019-05-16
Plain-language summary
Hidradenitis Suppurativa (HS) is a recurrent inflammatory disease (\< 2 episode /6 months) with 1%-4% prevalence in Europe. Suppurating lesions are painful and involve one or more regions (axilla, genitofemoral, perineum, gluteal areas and inframammary, creases).
For recalcitrant stage II and III, wide surgical skin excision is the only recommended and validated treatment in case inefficacity of medical conventional systemic therapies or limited-local surgery.
Perforator Flaps (PF) surgery, are a new and innovative surgical technique, that, unlike secondary wound healing, allows a single stage reconstruction at the same time as skin excision without its disadvantages.: prolonged healing time, with multiple painful dressings (costs) retractile scar with reduction of the range of motion, dyschromia, unstable and fragile scar.
The hypothesis of study is a 30% reduction of time to healing by using perforators flaps technique (PF) versus wound healing (SIWH), for axillary reconstruction after surgical wide excision in axillary hidradenitis suppurativa stage II or III in adults with inadequate response to conventional systemic therapy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years and ≤ 70 years
* Reproductive age patient with an effective contraception
* Patient with a previously diagnosed of axillary HS (defined by European S1 guidelines) Hurley Grade II or grade III and send by dermatologist for wide excision surgery, because of inefficacy, or insufficient response or failure (recurrence or resistance) of previous medical conventional systemic treatments or limited surgery
* Minimum delay of 1 month after an inflammatory phase of axillary HS treated medically
* Patient candidate for excision surface of the axillary region representing a minimum excision area of 6 (major axis) / 6 (minor axis) or 28.5 cm2 (ellipse surface recall = half of major axis X half of minor axis X π, in this case = 3 X 3 X π)
* Patient with health insurance (AME excepted)
* Signed written informed consent
Exclusion Criteria:
* Contra indication to general anesthesia, allergy to methylene blue (mandated for the excisional surgery)
* Pregnancy woman (confirmed by a urine test beta-HCG) or breastfeeding woman
* Patient already included in the study
* Participation in any other interventional study or in the exclusion period any other interventional study
* Contra indication to perforator flaps/wide excision : to general anesthesia (ASA \< IV Score Health Status), severe platelet disorders or patient at high risk of bleeding
* Acute superinfection grade ≥ 4 according to CTCAE in progress or diagnosed for less than 1 month
* Patient under le…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the efficacy at 6 months on the healing time of perforators flaps and secondary intention wound healing after wide surgical excision, for axillary HS stage II or III insufficiently responsive to conventional systemic treatment.