Status:
ACTIVE_NOT_RECRUITING
Perforator Flaps for Axillary Hidradenitis Suppurativa
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Axillary Hidradenitis Suppurativa
Eligibility:
All Genders
18-70 years
Phase:
NA
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, gen...
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) aft...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03784313
Start Date
May 16 2019
End Date
September 24 2024
Last Update
February 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP
Paris, France, 75020