Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01244-51 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study is designed as an open randomized clinical trial comparing the efficacy of perforators flaps technique (PF) to decrease the healing time, versus secondary intention wound healing (SIWH) after skin excision for axillary Hidradenitis suppurativa.
This study involves 8 centers (2 closed) plastic surgery
Patients will be randomized by the investigator after inclusion using a Case Report Form (e-CRF) CleanWeb, Telemedecin Technologies, S.A.S). Randomization will be stratified on center and on laterality (unilateral/bilateral); in case of bilateral axillary HS, side will be randomly assigned at the same time than surgery group.
Centralized blocked randomization according to a 1:1 ratio will be prepared by the Clinical Research Unit (URC-EST).
Primary endpoint
Healing time defined as :
If healing is not attended at the end of follow up, healing duration will be set at 6 months in both group
Secondary endpoints
To compare between groups:
VAS patient satisfaction for the aesthetic outcomes
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perforators flaps (PF group) | Experimental |
| |
| Secondary intention wound healing | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin repair by axillary perforator flaps | Procedure | Perforators flaps (PF) of the axillary region for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa. Perforated flap surgery does not involve any procedure or manipulation that may alter the biological characteristics and/or structural properties of the tissue (use autologue pur). A usual dressing is performed daily until complete healing. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael ATLAN, PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP | Paris | 75020 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| skin repair by secondary wound healing | Procedure | Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| Production costs of the new technique perforator flap from the hospital perspective | 12 months |
| Total average cost and incremental cost-utility ratio | 12 months |