Perforator Flaps for Axillary Hidradenitis Suppurativa (HS-PAX)

Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Axillary Hidradenitis Suppurativa
• Intervention / Treatment: Procedure: skin repair by axillary perforator flaps; Procedure: skin repair by secondary wound healing

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 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 :

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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 : 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.	6 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Michael ATLAN, PH, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Estimated): March 26, 2024
• Study Completion (Estimated): September 24, 2024

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Axillary Hidradenitis Suppurativa; Perforator flaps; Secondary intention wound healing
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: P170931J; 2018-A01244-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No