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NCT03784313: HS-PAX

Perforator Flaps for Axillary Hidradenitis Suppurativa

Status unknown NA Last updated 1 February 2024
What this trial tests

NA trial testing skin repair by axillary perforator flaps in Axillary Hidradenitis Suppurativa in 88 participants. Status unknown.

Timeline
16 May 2019
Primary endpoint
26 March 2024
24 September 2024

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment88
Start date16 May 2019
Primary completion26 March 2024
Estimated completion24 September 2024
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 70, any sex, with Axillary Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Hidradenitis Suppurativa: Where We Are and Where We Are Going.
    Scala E, Cacciapuoti S, Garzorz-Stark N, Megna M, et al · · 2021 · cited 85× · PMID 34440863 · DOI 10.3390/cells10082094

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