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Perforator Flaps for Axillary Hidradenitis Suppurativa

NCT03784313 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

  • Axillary Hidradenitis Suppurativa

Interventions

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.

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Michael ATLAN, PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2024-03-26
Completion
2024-09-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784313 on ClinicalTrials.gov