Hidradenitis Suppurativa (Acne Inversa)HSPUNCHNCT06731309
HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT
A study testing Punch Debridement and Incision and Drainage in people with Hidradenitis Suppurativa (Acne Inversa), run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This randomized-control trial is designed to determine the recurrence rate of HS abscesses following drainage via two methods: I\&D with a linear incision and PD with an 8mm punch biopsy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (Acne Inversa)
- What is being tested?
- Punch Debridement and Incision and Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with HS
- Has an abscess requiring drainage with a maximum diameter of 5 centimeters.
- Age 16 years or older
- Willing and able to provide informed consent
Who cannot join
- Has other conditions that could interfere with the study, as estimated by physician
- Unable to comply with follow-up visits
- Allergic to lidocaine and/or adrenaline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus MC
Rotterdam, South Holland
Hessel H van der Zee, +31 10 704 0110
About this study
Official title: ABSCESS DRAINAGE in HIDRADENITIS SUPPURATIVA: INCISION and DRAINAGE VERSUS PUNCH DEBRIDEMENT
This randomized-control trial is designed to determine the recurrence rate of HS abscesses following drainage via two methods: I\&D with a linear incision and PD with an 8mm punch biopsy. In this context, recurrence is a newly described HS abscess adjacent to or within the previously operated area, for which a second intervention is deemed necessary. We hypothesize that PD may yield a more favorable recurrence rate. In addition to comparing recurrence rates, this randomized-control trial will also evaluate postprocedural pain, the occurrence and type of complications, and patients' quality of life associated with both procedures. These additional factors are crucial in assessing the overall effectiveness and patient satisfaction associated with each method, further informing the potential establishment of PD as the new gold standard for draining small, painful, acute HS abscesses.
- Conditions
- Hidradenitis Suppurativa (Acne Inversa)
- Being tested
- Punch Debridement, Incision and Drainage
- Keywords
- punch biopsy tool, drainage, abscess, I&D
- Medical subject headings
- Hidradenitis Suppurativa, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch DebridementProcedure or surgery
A punch biopsy tool is positioned over the inflamed follicular unit, and a small circle of skin (4 to 8 mm in diameter) is excised. A firm twisting motion is necessary to ensure adequately deep excision.
Incision and DrainageProcedure or surgery
Incision and Drainage is a minimally invasive surgical procedure often employed for the treatment of intensely painful, tense, and fluctuant abscesses that are too deep to drain spontaneously. After administration of a broad circumferential local anesthetic, a small linear incision is made using a standard scalpel blade. Digital pressure is applied to expel the fluid collection. Saline rinses can be used to flush out the remaining contents. This method offers instant pain relief, commonly performed in acute settings by dermatologists, emergency department physicians and general practitioners
| Study group | Role | What they receive |
|---|---|---|
| Punch Debdridement | Experimental | After local anesthesia, a punch biopsy tool is positioned over the inflamed follicular unit, and a small circle of skin (4 to 8 mm in diameter) is excised. A firm twisting motion is necessary to ensure adequately deep excision. Similar to I\&D, this is followed by applying digital pressure and gauze scraping to eliminate the fluid contents. The wound is then left open to allow free drainage and heal by secondary intention. Receives: Procedure: Punch Debridement |
| Gold standard: Incision and Drainage | Active comparator | Incision and Drainage is a minimally invasive surgical procedure often employed for the treatment of intensely painful, tense, and fluctuant abscesses that are too deep to drain spontaneously. After administration of a broad circumferential local anesthetic, a small linear incision is made using a standard scalpel blade. Digital pressure is applied to expel the fluid collection. Saline rinses can be used to flush out the remaining contents. This method offers instant pain relief, commonly performed in acute settings by dermatologists, emergency department physicians and general practitioners. Receives: Procedure: Incision and Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence rate in percentage of abscesses recurring after drainage
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study startFeb 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (Acne Inversa)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with two intervention groups, one of which is gold standard intervention
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hessel H van der Zee, MD, PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731309
- Sponsor's protocol ID
- EMCD_12304
- Acronym
- HSPUNCH
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSCESS DRAINAGE in HIDRADENITIS SUPPURATIVA: INCISION and DRAINAGE VERSUS PUNCH DEBRIDEMENT
- ClinicalTrials.gov ID
- NCT06731309
- Acronym / sponsor ID
- HSPUNCH / EMCD_12304
- Conditions
- Hidradenitis Suppurativa (Acne Inversa)
- Keywords
- punch biopsy tool, drainage, abscess, I&D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Dec 2024 (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.
This randomized-control trial is designed to determine the recurrence rate of HS abscesses following drainage via two methods: I\&D with a linear incision and PD with an 8mm punch biopsy. In this context, recurrence is a newly described HS abscess adjacent to or within the previously operated area, for which a second intervention is deemed necessary. We hypothesize that PD may yield a more favorable recurrence rate. In addition to comparing recurrence rates, this randomized-control trial will also evaluate postprocedural pain, the occurrence and type of complications, and patients' quality of life associated with both procedures. These additional factors are crucial in assessing the overall effectiveness and patient satisfaction associated with each method, further informing the potential establishment of PD as the new gold standard for draining small, painful, acute HS abscesses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with two intervention groups, one of which is gold standard intervention
| Arm | Type | Receives |
|---|---|---|
| Punch Debdridement | Experimental | Procedure: Punch DebridementAfter local anesthesia, a punch biopsy tool is positioned over the inflamed follicular unit, and a small circle of skin (4 to 8 mm in diameter) is excised. A firm twisting motion is necessary to ensure adequately deep excision. Similar to I\&D, this is followed by applying digital pressure and gauze scraping to eliminate the fluid contents. The wound is then left open to allow free drainage and heal by secondary intention. |
| Gold standard: Incision and Drainage | Active comparator | Procedure: Incision and DrainageIncision and Drainage is a minimally invasive surgical procedure often employed for the treatment of intensely painful, tense, and fluctuant abscesses that are too deep to drain spontaneously. After administration of a broad circumferential local anesthetic, a small linear incision is made using a standard scalpel blade. Digital pressure is applied to expel the fluid collection. Saline rinses can be used to flush out the remaining contents. This method offers instant pain relief, commonly performed in acute settings by dermatologists, emergency department physicians and general practitioners. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with HS
- Has an abscess requiring drainage with a maximum diameter of 5 centimeters.
- Age 16 years or older
- Willing and able to provide informed consent
Key exclusion criteria (3 listed)
- Has other conditions that could interfere with the study, as estimated by physician
- Unable to comply with follow-up visits
- Allergic to lidocaine and/or adrenaline.
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 |
|---|---|---|
| Punch DebridementA punch biopsy tool is positioned over the inflamed follicular unit, and a small circle of skin (4 to 8 mm in diameter) is excised. A firm twisting motion is necessary to ensure adequately deep excision. | Procedure or surgery | Punch Debdridement |
| Incision and DrainageIncision and Drainage is a minimally invasive surgical procedure often employed for the treatment of intensely painful, tense, and fluctuant abscesses that are too deep to drain spontaneously. After administration of a broad circumferential local anesthetic, a small linear incision is made using a standard scalpel blade. Digital pressure is applied to expel the fluid collection. Saline rinses can be used to flush out the remaining contents. This method offers instant pain relief, commonly performed in acute settings by dermatologists, emergency department physicians and general practitioners | Procedure or surgery | Gold standard: Incision and Drainage |
Primary outcome
Recurrence
Time frame: 1 month
Recurrence rate in percentage of abscesses recurring after drainage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa (Acne Inversa)
Active, not recruitingPhase 2
A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
Hidradenitis Suppurativa
Not yet recruitingObservational study
A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
Hidradenitis Suppurativa
Active, not recruitingPhase 2
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study With CIT-013 in HS Patients
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
Hidradenitis Suppurativa (HS)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punch Debridement and Incision and Drainage in people with Hidradenitis Suppurativa (Acne Inversa), run by Erasmus Medical Center at 1 site in Netherlands.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Dec 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 Netherlands. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hessel H van der Zee, MD, PhD (+31 10 704 0110, h.vanderzee@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 1 month). 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 12 Dec 2024.