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Perforator Flaps for Axillary Hidradenitis Suppurativa (HS-PAX)

Primary Purpose

Axillary Hidradenitis Suppurativa

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
skin repair by axillary perforator flaps
skin repair by secondary wound healing
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Axillary Hidradenitis Suppurativa focused on measuring Axillary Hidradenitis Suppurativa, Perforator flaps, Secondary intention wound healing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Perforators flaps (PF group)

Secondary intention wound healing

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Shoulder mobility on the operated side, evaluated by the DASH score
The DASH score (Disabilities of the Arm, Shoulder and Hand)
Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction
The amplitude of arm abduction using a goniometer
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
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
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.
Evolutions during the 12-months follow in quality of life by using DLQI
DLQI questionnaire will be analyzed according to the scoring manual.
Evolutions during the 12-months follow in quality of life by using EQ 5D
EQ5D questionnaire will be analyzed according to the scoring manual.
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.
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.
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)
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)
Production costs of the new technique perforator flap from the hospital perspective
Total average cost and incremental cost-utility ratio

Full Information

First Posted
November 13, 2018
Last Updated
December 20, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03784313
Brief Title
Perforator Flaps for Axillary Hidradenitis Suppurativa
Acronym
HS-PAX
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hidradenitis Suppurativa
Keywords
Axillary Hidradenitis Suppurativa, Perforator flaps, Secondary intention wound healing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perforators flaps (PF group)
Arm Type
Experimental
Arm Title
Secondary intention wound healing
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
skin repair by axillary perforator flaps
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
skin repair by secondary wound healing
Intervention Description
Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa
Primary Outcome Measure Information:
Title
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.
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
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.
Time Frame
12 months
Title
Shoulder mobility on the operated side, evaluated by the DASH score
Description
The DASH score (Disabilities of the Arm, Shoulder and Hand)
Time Frame
Day10, Month 3, Month 6 and Month12
Title
Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction
Description
The amplitude of arm abduction using a goniometer
Time Frame
Day10, Month 3, Month 6 and Month12
Title
Length of stay at the hospital from surgery to the discharge
Description
Length of stay at the hospital will be compared between groups using Student t tests or Wilcoxon rank-sum tests, as needed
Time Frame
Day 7
Title
Time from surgery to return to daily activity
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
Time Frame
Month 1, Month 3, Month 6
Title
Evolutions during the 12-months follow in quality of life by using MOS-SF36
Description
MOS-SF36 questionnaire will be analyzed according to the scoring manual.
Time Frame
Up to Month 12.
Title
Evolutions during the 12-months follow in quality of life by using DLQI
Description
DLQI questionnaire will be analyzed according to the scoring manual.
Time Frame
Up to Month 12.
Title
Evolutions during the 12-months follow in quality of life by using EQ 5D
Description
EQ5D questionnaire will be analyzed according to the scoring manual.
Time Frame
Up to Month 12.
Title
Aesthetic outcomes of the axillae at 12 months
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.
Time Frame
Month 12
Title
Complication rates at 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.
Time Frame
3 months
Title
Evolution of the Analogic Visual Scale for Pain
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)
Time Frame
Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6
Title
Evolution of patient satisfaction by VAS
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)
Time Frame
Month 1/ Month 3/ Month 6/ Month 12
Title
Production costs of the new technique perforator flap from the hospital perspective
Time Frame
12 months
Title
Total average cost and incremental cost-utility ratio
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael ATLAN, PH
Phone
01 56 01 79 35/01 56 01 75 69
Email
michael.atlan@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Benoit CHAPUT, PH
Phone
05 61 32 28 82/05 61 32 27 42
Email
chapub.b@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael ATLAN, PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael ATLAN, PH
Phone
01 56 01 79 35/01 56 01 75 69
Email
michael.atlan@aphp.fr
First Name & Middle Initial & Last Name & Degree
Benoit CHAPUT, PH
Phone
05 61 32 28 82 /05 61 32 27 42
Email
chapub.b@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perforator Flaps for Axillary Hidradenitis Suppurativa

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