<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784313</url>
  </required_header>
  <id_info>
    <org_study_id>P170931J</org_study_id>
    <secondary_id>2018-A01244-51</secondary_id>
    <nct_id>NCT03784313</nct_id>
  </id_info>
  <brief_title>Perforator Flaps for Axillary Hidradenitis Suppurativa</brief_title>
  <acronym>HS-PAX</acronym>
  <official_title>Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hidradenitis Suppurativa (HS) is a recurrent inflammatory disease (&lt; 2 episode /6 months)&#xD;
      with 1%-4% prevalence in Europe. Suppurating lesions are painful and involve one or more&#xD;
      regions (axilla, genitofemoral, perineum, gluteal areas and inframammary, creases).&#xD;
&#xD;
      For recalcitrant stage II and III, wide surgical skin excision is the only recommended and&#xD;
      validated treatment in case inefficacity of medical conventional systemic therapies or&#xD;
      limited-local surgery.&#xD;
&#xD;
      Perforator Flaps (PF) surgery, are a new and innovative surgical technique, that, unlike&#xD;
      secondary wound healing, allows a single stage reconstruction at the same time as skin&#xD;
      excision without its disadvantages.: prolonged healing time, with multiple painful dressings&#xD;
      (costs) retractile scar with reduction of the range of motion, dyschromia, unstable and&#xD;
      fragile scar.&#xD;
&#xD;
      The hypothesis of study is a 30% reduction of time to healing by using perforators flaps&#xD;
      technique (PF) versus wound healing (SIWH), for axillary reconstruction after surgical wide&#xD;
      excision in axillary hidradenitis suppurativa stage II or III in adults with inadequate&#xD;
      response to conventional systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as an open randomized clinical trial comparing the efficacy of&#xD;
      perforators flaps technique (PF) to decrease the healing time, versus secondary intention&#xD;
      wound healing (SIWH) after skin excision for axillary Hidradenitis suppurativa.&#xD;
&#xD;
      This study involves 5 centers plastic surgery&#xD;
&#xD;
      Patients will be randomized by the investigator after inclusion using a Case Report Form&#xD;
      (e-CRF) CleanWeb, Telemedecin Technologies, S.A.S). Randomization will be stratified on&#xD;
      center and on laterality (unilateral/bilateral); in case of bilateral axillary HS, side will&#xD;
      be randomly assigned at the same time than surgery group.&#xD;
&#xD;
      Centralized blocked randomization according to a 1:1 ratio will be prepared by the Clinical&#xD;
      Research Unit (URC-EST).&#xD;
&#xD;
      Primary endpoint&#xD;
&#xD;
      Healing time defined as :&#xD;
&#xD;
        1. In SIWH group: time between the excisional surgery and total re-epithelialization&#xD;
           (100%), treatment of potential wound healing delay related to complications included.&#xD;
&#xD;
        2. in PF group : time between the excisional surgery and the day of last stiches&#xD;
           removal(closed incision), treatment of potential delay related to complications included&#xD;
           .If partial necrosis&lt; 50 %, occurs and is treated by SIWH , the secondary end point will&#xD;
           be the total re-epithelialization.&#xD;
&#xD;
      If healing is not attended at the end of follow up, healing duration will be set at 6 months&#xD;
      in both group&#xD;
&#xD;
      Secondary endpoints&#xD;
&#xD;
      To compare between groups:&#xD;
&#xD;
        -  Recurrence rate during a follow-up of 12 months: new signs of disease in the axilla&#xD;
           despite surgical treatment and Hurley staging of the involved axilla .&#xD;
&#xD;
        -  Disabilities of the Arm, Shoulder and Hand score (DASH) and of the measurement of the&#xD;
           amplitude of arm abduction using a goniometer : differences between inclusion and M3,&#xD;
           M6, M12.&#xD;
&#xD;
        -  Length of stay at the hospital at the discharge&#xD;
&#xD;
        -  Time from surgery to return to daily activity&#xD;
&#xD;
        -  Quality of life between inclusion and at M3, M6, M12; with MOS-SF36 / Dermatology Life&#xD;
           Quality Index (DLQI)/ EQ 5D&#xD;
&#xD;
        -  Aesthetic outcomes: VAS (1: worst aesthetic result-10 : best aesthetic result) obtained&#xD;
           after submission of the pre/post-operative pictures of the axillary region to a&#xD;
           medical/paramedical panel at M12 and patient satisfaction for the aesthetic outcomes at&#xD;
           M12 with the same scale, Pre/post-operative pictures of the axillary region will be&#xD;
           submitted to a medical/paramedical panel and measured with the same Visual Analogic&#xD;
           scale (VAS) aesthetic outcomes 3 Pictures&#xD;
&#xD;
        -  1 face Arm elevated with the 2 axillae in the frame, 1 of the axillae face, 1 of the&#xD;
           axillae profil&#xD;
&#xD;
        -  The day of the surgery or one day before surgery: a picture to determine the size of the&#xD;
           lesion (arm 90°) and with the size of the defect (Ruler or dimension written on the&#xD;
           skin) after skin excision.&#xD;
&#xD;
      VAS patient satisfaction for the aesthetic outcomes&#xD;
&#xD;
        -  Complication rates during a follow up of 3 months: hematoma, infection, cutaneous&#xD;
           necrosis&#xD;
&#xD;
        -  Pain (Visual Analogic Scale): before patient discharge, every 15 days until wound&#xD;
           healing and at M3 and M6.&#xD;
&#xD;
        -  Production costs of the new technique perforator flap from the hospital perspective&#xD;
&#xD;
        -  Total average cost and incremental cost-utility ratio&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>6 months</time_frame>
    <description>Primary assessment criterion is the mean Healing time during a 6 months follow up defined as :&#xD;
In SIWH group: time between the excisional surgery and total re-epithelialization (100%), treatment of potential delay related to complications included.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder mobility on the operated side, evaluated by the DASH score</measure>
    <time_frame>Day10, Month 3, Month 6 and Month12</time_frame>
    <description>The DASH score (Disabilities of the Arm, Shoulder and Hand)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction</measure>
    <time_frame>Day10, Month 3, Month 6 and Month12</time_frame>
    <description>The amplitude of arm abduction using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay at the hospital from surgery to the discharge</measure>
    <time_frame>Day 7</time_frame>
    <description>Length of stay at the hospital will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from surgery to return to daily activity</measure>
    <time_frame>Month 1, Month 3, Month 6</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolutions during the 12-months follow in quality of life by using MOS-SF36</measure>
    <time_frame>Up to Month 12.</time_frame>
    <description>MOS-SF36 questionnaire will be analyzed according to the scoring manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolutions during the 12-months follow in quality of life by using DLQI</measure>
    <time_frame>Up to Month 12.</time_frame>
    <description>DLQI questionnaire will be analyzed according to the scoring manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolutions during the 12-months follow in quality of life by using EQ 5D</measure>
    <time_frame>Up to Month 12.</time_frame>
    <description>EQ5D questionnaire will be analyzed according to the scoring manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic outcomes of the axillae at 12 months</measure>
    <time_frame>Month 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Analogic Visual Scale for Pain</measure>
    <time_frame>Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6</time_frame>
    <description>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.&#xD;
VAS ( 0 : none 10: extreme amount of pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of patient satisfaction by VAS</measure>
    <time_frame>Month 1/ Month 3/ Month 6/ Month 12</time_frame>
    <description>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.&#xD;
VAS ( 0 : Totally dissatisfied 10 : Fully satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Production costs of the new technique perforator flap from the hospital perspective</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total average cost and incremental cost-utility ratio</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Axillary Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>Perforators flaps (PF group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary intention wound healing</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>skin repair by axillary perforator flaps</intervention_name>
    <description>Perforators flaps (PF) of the axillary region for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa.&#xD;
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.</description>
    <arm_group_label>Perforators flaps (PF group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>skin repair by secondary wound healing</intervention_name>
    <description>Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa</description>
    <arm_group_label>Secondary intention wound healing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years and ≤ 70 years&#xD;
&#xD;
          -  Reproductive age patient with an effective contraception&#xD;
&#xD;
          -  Patient with a previously diagnosed of axillary HS (defined by European S1 guidelines)&#xD;
             Hurley Grade II or grade III and send by dermatologist for wide excision surgery,&#xD;
             because of inefficacy, or insufficient response or failure (recurrence or resistance)&#xD;
             of previous medical conventional systemic treatments or limited surgery&#xD;
&#xD;
          -  Minimum delay of 1 month after an inflammatory phase of axillary HS treated medically&#xD;
&#xD;
          -  Patient candidate for excision surface of the axillary region representing a minimum&#xD;
             excision area of 6 (major axis) / 6 (minor axis) or 28.5 cm2 (ellipse surface recall =&#xD;
             half of major axis X half of minor axis X π, in this case = 3 X 3 X π)&#xD;
&#xD;
          -  Patient with health insurance (AME excepted)&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra indication to general anesthesia, allergy to methylene blue (mandated for the&#xD;
             excisional surgery)&#xD;
&#xD;
          -  Pregnancy woman (confirmed by a urine test beta-HCG) or breastfeeding woman&#xD;
&#xD;
          -  Patient already included in the study&#xD;
&#xD;
          -  Participation in any other interventional study or in the exclusion period any other&#xD;
             interventional study&#xD;
&#xD;
          -  Contra indication to perforator flaps/wide excision : to general anesthesia (ASA &lt; IV&#xD;
             Score Health Status), severe platelet disorders or patient at high risk of bleeding&#xD;
&#xD;
          -  Acute superinfection grade ≥ 4 according to CTCAE in progress or diagnosed for less&#xD;
             than 1 month&#xD;
&#xD;
          -  Patient under legal protection measure and or deprived of freedom&#xD;
&#xD;
          -  Patient unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael ATLAN, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael ATLAN, PH</last_name>
    <phone>01 56 01 79 35/01 56 01 75 69</phone>
    <email>michael.atlan@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benoit CHAPUT, PH</last_name>
    <phone>05 61 32 28 82/05 61 32 27 42</phone>
    <email>chapub.b@chu-toulouse.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Michael ATLAN, PH</last_name>
      <phone>01 56 01 79 35/01 56 01 75 69</phone>
      <email>michael.atlan@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Benoit CHAPUT, PH</last_name>
      <phone>05 61 32 28 82 /05 61 32 27 42</phone>
      <email>chapub.b@chu-toulouse.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Axillary Hidradenitis Suppurativa</keyword>
  <keyword>Perforator flaps</keyword>
  <keyword>Secondary intention wound healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784313
org study id: P170931J
secondary id: 2018-A01244-51
nct id: NCT03784313
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 5 centers 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 :

        1. In SIWH group: time between the excisional surgery and total re-epithelialization
           (100%), treatment of potential wound healing delay related to complications included.

        2. in PF group : time between the excisional surgery and the day of last stiches
           removal(closed incision), treatment of potential delay related to complications included
           .If partial necrosis< 50 %, occurs and is treated by SIWH , the secondary end point will
           be the total re-epithelialization.

      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:

        -  Recurrence rate during a follow-up of 12 months: new signs of disease in the axilla
           despite surgical treatment and Hurley staging of the involved axilla .

        -  Disabilities of the Arm, Shoulder and Hand score (DASH) and of the measurement of the
           amplitude of arm abduction using a goniometer : differences between inclusion and M3,
           M6, M12.

        -  Length of stay at the hospital at the discharge

        -  Time from surgery to return to daily activity

        -  Quality of life between inclusion and at M3, M6, M12; with MOS-SF36 / Dermatology Life
           Quality Index (DLQI)/ EQ 5D

        -  Aesthetic outcomes: VAS (1: worst aesthetic result-10 : best aesthetic result) obtained
           after submission of the pre/post-operative pictures of the axillary region to a
           medical/paramedical panel at M12 and patient satisfaction for the aesthetic outcomes at
           M12 with the same scale, Pre/post-operative pictures of the axillary region will be
           submitted to a medical/paramedical panel and measured with the same Visual Analogic
           scale (VAS) aesthetic outcomes 3 Pictures

        -  1 face Arm elevated with the 2 axillae in the frame, 1 of the axillae face, 1 of the
           axillae profil

        -  The day of the surgery or one day before surgery: a picture to determine the size of the
           lesion (arm 90°) and with the size of the defect (Ruler or dimension written on the
           skin) after skin excision.

      VAS patient satisfaction for the aesthetic outcomes

        -  Complication rates during a follow up of 3 months: hematoma, infection, cutaneous
           necrosis

        -  Pain (Visual Analogic Scale): before patient discharge, every 15 days until wound
           healing and at M3 and M6.

        -  Production costs of the new technique perforator flap from the hospital perspective

        -  Total average cost and incremental cost-utility ratio
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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.
time frame: 6 months
description: 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.
measure: 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
time frame: 12 months
description: 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.
measure: Shoulder mobility on the operated side, evaluated by the DASH score
time frame: Day10, Month 3, Month 6 and Month12
description: The DASH score (Disabilities of the Arm, Shoulder and Hand)
measure: Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction
time frame: Day10, Month 3, Month 6 and Month12
description: The amplitude of arm abduction using a goniometer
measure: Length of stay at the hospital from surgery to the discharge
time frame: Day 7
description: Length of stay at the hospital will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed
measure: Time from surgery to return to daily activity
time frame: Month 1, Month 3, Month 6
description: 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
measure: Evolutions during the 12-months follow in quality of life by using MOS-SF36
time frame: Up to Month 12.
description: MOS-SF36 questionnaire will be analyzed according to the scoring manual.
measure: Evolutions during the 12-months follow in quality of life by using DLQI
time frame: Up to Month 12.
description: DLQI questionnaire will be analyzed according to the scoring manual.
measure: Evolutions during the 12-months follow in quality of life by using EQ 5D
time frame: Up to Month 12.
description: EQ5D questionnaire will be analyzed according to the scoring manual.
measure: Aesthetic outcomes of the axillae at 12 months
time frame: Month 12
description: 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.
measure: Complication rates at 3 months
time frame: 3 months
description: 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.
measure: Evolution of the Analogic Visual Scale for Pain
time frame: Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6
description: 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)
measure: Evolution of patient satisfaction by VAS
time frame: Month 1/ Month 3/ Month 6/ Month 12
description: 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)
measure: Production costs of the new technique perforator flap from the hospital perspective
time frame: 12 months
measure: Total average cost and incremental cost-utility ratio
time frame: 12 months
arm group label: Perforators flaps (PF group)
arm group type: Experimental
arm group label: Secondary intention wound healing
arm group type: Sham Comparator
intervention type: Procedure
intervention name: skin repair by axillary perforator flaps
description: 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.
arm group label: Perforators flaps (PF group)
intervention type: Procedure
intervention name: skin repair by secondary wound healing
description: Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa
arm group label: Secondary intention wound healing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Michael ATLAN, PH
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Michael ATLAN, PH
phone: 01 56 01 79 35/01 56 01 75 69
email: michael.atlan@aphp.fr
last name: Benoit CHAPUT, PH
phone: 05 61 32 28 82/05 61 32 27 42
email: chapub.b@chu-toulouse.fr
facility: 
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: No