Axillary Hidradenitis SuppurativaHS-PAXNCT03784313
Perforator Flaps for Axillary Hidradenitis Suppurativa
A study testing skin repair by axillary perforator flaps and skin repair by secondary wound healing in people with Axillary Hidradenitis Suppurativa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Axillary Hidradenitis Suppurativa
- What is being tested?
- skin repair by axillary perforator flaps and skin repair by secondary wound healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2019to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP
Paris, 75020
About this study
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
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.
Read more
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.
Read the 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 :
- In SIWH group: time between the excisional surgery and total re-epithelialization (100%), treatment of potential wound healing delay related to complications included.
- 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
- Conditions
- Axillary Hidradenitis Suppurativa
- Being tested
- skin repair by axillary perforator flaps, skin repair by secondary wound healing
- Keywords
- Axillary Hidradenitis Suppurativa, Perforator flaps, Secondary intention wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin repair by axillary perforator flapsProcedure or surgery
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.
skin repair by secondary wound healingProcedure or surgery
Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa
| Study group | Role | What they receive |
|---|---|---|
| Perforators flaps (PF group) | Experimental | Not described Receives: Procedure: skin repair by axillary perforator flaps |
| Secondary intention wound healing | Sham comparator | Not described Receives: Procedure: skin repair by secondary wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (14)
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.
Measured: 12 months
Shoulder mobility on the operated side, evaluated by the DASH score
The DASH score (Disabilities of the Arm, Shoulder and Hand)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Month 1/ Month 3/ Month 6/ Month 12
Production costs of the new technique perforator flap from the hospital perspective
Measured: 12 months
Total average cost and incremental cost-utility ratio
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start16 May 2019
- Primary completion26 Mar 2024 (estimated)
- Study completion24 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael ATLAN, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784313
- Sponsor's protocol ID
- P170931J
- Other IDs
- 2018-A01244-51
- Acronym
- HS-PAX
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2018
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03784313
- Acronym / sponsor ID
- HS-PAX / P170931J
- Conditions
- Axillary Hidradenitis Suppurativa
- Keywords
- Axillary Hidradenitis Suppurativa, Perforator flaps, Secondary intention wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 26 Mar 2024 (estimated)
- Study completion
- 24 Sep 2024 (estimated)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- In SIWH group: time between the excisional surgery and total re-epithelialization (100%), treatment of potential wound healing delay related to complications included.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforators flaps (PF group) | Experimental | Procedure: skin repair by axillary perforator flaps |
| Secondary intention wound healing | Sham comparator | Procedure: skin repair by secondary wound healing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin repair by axillary perforator flapsPerforators 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 or surgery | Perforators flaps (PF group) |
| skin repair by secondary wound healingSecondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa | Procedure or surgery | Secondary intention wound healing |
Primary outcome
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.
14 secondary outcomes
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
Shoulder mobility on the operated side, evaluated by the DASH score
Time frame: Day10, Month 3, Month 6 and Month12
Shoulder mobility on the operated side, by the measurement of the amplitude of arm abduction
Time frame: Day10, Month 3, Month 6 and Month12
Length of stay at the hospital from surgery to the discharge
Time frame: Day 7
Time from surgery to return to daily activity
Time frame: Month 1, Month 3, Month 6
Evolutions during the 12-months follow in quality of life by using MOS-SF36
Time frame: Up to Month 12.
Evolutions during the 12-months follow in quality of life by using DLQI
Time frame: Up to Month 12.
Evolutions during the 12-months follow in quality of life by using EQ 5D
Time frame: Up to Month 12.
Aesthetic outcomes of the axillae at 12 months
Time frame: Month 12
Complication rates at 3 months
Time frame: 3 months
Evolution of the Analogic Visual Scale for Pain
Time frame: Day10 / Day0 to Day7, Day15 Month 1/Month 3 /Month 6
Evolution of patient satisfaction by VAS
Time frame: Month 1/ Month 3/ Month 6/ Month 12
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael ATLAN, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin repair by axillary perforator flaps and skin repair by secondary wound healing in people with Axillary Hidradenitis Suppurativa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.