Axillary Hidradenitis Suppurativa Clinical Trial
— HS-PAXOfficial title:
Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial
| Verified date | January 2024 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 88 |
| Est. completion date | September 24, 2024 |
| Est. primary completion date | March 26, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 p, in this case = 3 X 3 X p) - 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 legal protection measure and or deprived of freedom - Patient unable to consent |
| Country | Name | City | State |
|---|---|---|---|
| France | Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Primary assessment criterion is the mean Healing time during a 6 months follow up defined as :
In SIWH group: time between the excisional surgery and total re-epithelialization (100%), treatment of potential delay related to complications included. in PF group : time between the excisional surgery and the day of last stiches removal(closed incision of the recipient site and donor site), treatment of potential delay related to complications included. |
6 months | |
| Secondary | Recurrence rate during the 12-months follow-up defined as: new signs of disease in the axilla despite surgical treatment and Hurley staging of the involved axilla | The recurrence severity is described by the Hurley staging of the involved axilla. Hurley staging of the involved axilla will be described and compared between groups by a Fischer's exact test. | 12 months | |
| Secondary | Shoulder mobility on the operated side, evaluated by the DASH score | The DASH score (Disabilities of the Arm, Shoulder and Hand) | Day10, Month 3, Month 6 and Month12 | |
| Secondary | Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction | The amplitude of arm abduction using a goniometer | Day10, Month 3, Month 6 and Month12 | |
| Secondary | Length of stay at the hospital from surgery to the discharge | Length of stay at the hospital will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed | Day 7 | |
| Secondary | Time from surgery to return to daily activity | Time from surgery to return to work, to school-university, daily activity (if unemployed) will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed | Month 1, Month 3, Month 6 | |
| Secondary | Evolutions during the 12-months follow in quality of life by using MOS-SF36 | MOS-SF36 questionnaire will be analyzed according to the scoring manual. | Up to Month 12. | |
| Secondary | Evolutions during the 12-months follow in quality of life by using DLQI | DLQI questionnaire will be analyzed according to the scoring manual. | Up to Month 12. | |
| Secondary | Evolutions during the 12-months follow in quality of life by using EQ 5D | EQ5D questionnaire will be analyzed according to the scoring manual. | Up to Month 12. | |
| Secondary | Aesthetic outcomes of the axillae at 12 months | Aesthetic outcomes at 12 months according to patients and to the medical panel (VAS 0: worst aesthetic result - 10 : best aesthetic result) will be assessed using Student t tests or Wilcoxon rank-sum tests, as needed. | Month 12 | |
| Secondary | Complication rates at 3 months | described by complication (hematoma, hemorrhage, infection, wound dehiscence, skin necrosis, scar retraction) and as a total complication rate and compared between groups using a Pearson Chi square test or a Fisher's exact test, when appropriate. | 3 months | |
| Secondary | Evolution of the Analogic Visual Scale for Pain | Pain evolution will be described graphically and may be compared between groups using a linear mixed model, if possible. In case of non-normality distribution of the interest variable, a transformation could be realized.
VAS ( 0 : none 10: extreme amount of pain) |
Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6 | |
| Secondary | Evolution of patient satisfaction by VAS | Satisfaction evolution will be described graphically and may be compared between groups using a linear mixed model, if possible. In case of non-normality distribution of the interest variable, a transformation could be realized.
VAS ( 0 : Totally dissatisfied 10 : Fully satisfied) |
Month 1/ Month 3/ Month 6/ Month 12 | |
| Secondary | Production costs of the new technique perforator flap from the hospital perspective | 12 months | ||
| Secondary | Total average cost and incremental cost-utility ratio | 12 months |