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Trial record 12 of 90 for:    hidradenitis suppurativa

Perforator Flaps for Axillary Hidradenitis Suppurativa (HS-PAX)

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ClinicalTrials.gov Identifier: NCT03784313
Recruitment Status : Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Axillary Hidradenitis Suppurativa Procedure: skin repair by axillary perforator flaps Procedure: skin repair by secondary wound healing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Perforators flaps (PF group) Procedure: skin repair by axillary perforator flaps

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.


Sham Comparator: Secondary intention wound healing Procedure: skin repair by secondary wound healing
Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa




Primary Outcome Measures :
  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. [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Shoulder mobility on the operated side, evaluated by the DASH score [ Time Frame: Day10, Month 3, Month 6 and Month12 ]
    The DASH score (Disabilities of the Arm, Shoulder and Hand)

  3. Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction [ Time Frame: Day10, Month 3, Month 6 and Month12 ]
    The amplitude of arm abduction using a goniometer

  4. Length of stay at the hospital from surgery to the discharge [ Time Frame: Day 7 ]
    Length of stay at the hospital will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed

  5. Time from surgery to return to daily activity [ Time Frame: Month 1, Month 3, Month 6 ]
    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

  6. Evolutions during the 12-months follow in quality of life by using MOS-SF36 [ Time Frame: Up to Month 12. ]
    MOS-SF36 questionnaire will be analyzed according to the scoring manual.

  7. Evolutions during the 12-months follow in quality of life by using DLQI [ Time Frame: Up to Month 12. ]
    DLQI questionnaire will be analyzed according to the scoring manual.

  8. Evolutions during the 12-months follow in quality of life by using EQ 5D [ Time Frame: Up to Month 12. ]
    EQ5D questionnaire will be analyzed according to the scoring manual.

  9. Aesthetic outcomes of the axillae at 12 months [ Time Frame: Month 12 ]
    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.

  10. Complication rates at 3 months [ Time Frame: 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.

  11. Evolution of the Analogic Visual Scale for Pain [ Time Frame: Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6 ]

    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)


  12. Evolution of patient satisfaction by VAS [ Time Frame: Month 1/ Month 3/ Month 6/ Month 12 ]

    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)


  13. Production costs of the new technique perforator flap from the hospital perspective [ Time Frame: 12 months ]
  14. Total average cost and incremental cost-utility ratio [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 legal protection measure and or deprived of freedom
  • Patient unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784313


Contacts
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Contact: Michael ATLAN, PH 01 56 01 79 35/01 56 01 75 69 michael.atlan@aphp.fr
Contact: Benoit CHAPUT, PH 05 61 32 28 82/05 61 32 27 42 chapub.b@chu-toulouse.fr

Locations
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France
Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP Not yet recruiting
Paris, France, 75020
Contact: Michael ATLAN, PH    01 56 01 79 35/01 56 01 75 69    michael.atlan@aphp.fr   
Contact: Benoit CHAPUT, PH    05 61 32 28 82 /05 61 32 27 42    chapub.b@chu-toulouse.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Michael ATLAN, PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03784313     History of Changes
Other Study ID Numbers: P170931J
2018-A01244-51 ( Other Identifier: ANSM )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Axillary Hidradenitis Suppurativa
Perforator flaps
Secondary intention wound healing
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration