ClinicalTrials.gg
Not yet recruitingNCT06731309HSPUNCHUpdated Dec 12, 2024

HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT

An interventional study of Punch Debridement and Incision and Drainage in Hidradenitis Suppurativa (Acne Inversa), sponsored by Erasmus Medical Center. Not yet recruiting at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hidradenitis Suppurativa (Acne Inversa)

Keywords

  • punch biopsy tool
  • drainage
  • abscess
  • I&D
03

In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's planned enrollment of 72 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Punch Debdridement

    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.

    Procedure: Punch Debridement

  • Active comparator
    Gold standard: Incision and Drainage

    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.

    Procedure: Incision and Drainage

Interventions

  • ProcedurePunch Debridement

    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.

  • ProcedureIncision and Drainage

    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

06

What researchers measure

Primary outcomes

  1. Recurrence

    Recurrence rate in percentage of abscesses recurring after drainage

    Time frame: 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06731309
Responsible party
Hessel H van der Zee, MD, PhD (MD, PhD, Erasmus Medical Center) — Principal investigator
First posted
Dec 12, 2024
Start date
Feb 2025 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Dec 12, 2024

Study contacts

Hessel H van der Zee, MD, PhD
Contact
h.vanderzee@erasmusmc.nl
+31 10 704 0110

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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