Perforator Flaps for Axillary Hidradenitis Suppurativa (HS-PAX)
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|ClinicalTrials.gov Identifier: NCT03784313|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Axillary Hidradenitis Suppurativa||Procedure: skin repair by axillary perforator flaps Procedure: skin repair by secondary wound healing||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||January 2022|
|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
- 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. [ Time Frame: 6 months ]
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.
- 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 [ Time Frame: 12 months ]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 [ Time Frame: Day10, Month 3, Month 6 and Month12 ]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 [ Time Frame: Day10, Month 3, Month 6 and Month12 ]The amplitude of arm abduction using a goniometer
- Length of stay at the hospital from surgery to the discharge [ Time Frame: Day 7 ]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 Frame: Month 1, Month 3, Month 6 ]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 [ Time Frame: Up to Month 12. ]MOS-SF36 questionnaire will be analyzed according to the scoring manual.
- Evolutions during the 12-months follow in quality of life by using DLQI [ Time Frame: Up to Month 12. ]DLQI questionnaire will be analyzed according to the scoring manual.
- Evolutions during the 12-months follow in quality of life by using EQ 5D [ Time Frame: Up to Month 12. ]EQ5D questionnaire will be analyzed according to the scoring manual.
- Aesthetic outcomes of the axillae at 12 months [ Time Frame: Month 12 ]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 [ Time Frame: 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 [ Time Frame: Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6 ]
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 [ Time Frame: Month 1/ Month 3/ Month 6/ Month 12 ]
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 [ Time Frame: 12 months ]
- Total average cost and incremental cost-utility ratio [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784313
|Contact: Michael ATLAN, PH||01 56 01 79 35/01 56 01 75 email@example.com|
|Contact: Benoit CHAPUT, PH||05 61 32 28 82/05 61 32 27 firstname.lastname@example.org|
|Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP||Not yet recruiting|
|Paris, France, 75020|
|Contact: Michael ATLAN, PH 01 56 01 79 35/01 56 01 75 69 email@example.com|
|Contact: Benoit CHAPUT, PH 05 61 32 28 82 /05 61 32 27 42 firstname.lastname@example.org|
|Principal Investigator:||Michael ATLAN, PH||Assistance Publique - Hôpitaux de Paris|