Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 6 months
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.
次要结局
- Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction(Day10, Month 3, Month 6 and Month12)
- Length of stay at the hospital from surgery to the discharge(Day 7)
- Time from surgery to return to daily activity(Month 1, Month 3, Month 6)
- Evolutions during the 12-months follow in quality of life by using MOS-SF36(Up to Month 12.)
- Complication rates at 3 months(3 months)
- Production costs of the new technique perforator flap from the hospital perspective(12 months)
- Aesthetic outcomes of the axillae at 12 months(Month 12)
- 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(12 months)
- Shoulder mobility on the operated side, evaluated by the DASH score(Day10, Month 3, Month 6 and Month12)
- Total average cost and incremental cost-utility ratio(12 months)
- Evolutions during the 12-months follow in quality of life by using DLQI(Up to Month 12.)
- Evolutions during the 12-months follow in quality of life by using EQ 5D(Up to Month 12.)
- Evolution of the Analogic Visual Scale for Pain(Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6)
- Evolution of patient satisfaction by VAS(Month 1/ Month 3/ Month 6/ Month 12)