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Not yet recruiting NCT06731309

HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT

No phase Interventional Hidradenitis Suppurativa (Acne Inversa)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Punch Debridement, Incision and Drainage.
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa (Acne Inversa). Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ABSCESS DRAINAGE in HIDRADENITIS SUPPURATIVA: INCISION and DRAINAGE VERSUS PUNCH DEBRIDEMENT

Overview

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.

Interventions

  • Procedure Punch 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.
  • Procedure 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 perfor

Primary outcome measures

  • Recurrence [Time frame: 1 month]

Eligibility criteria

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 informed consent

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Erasmus MC — Rotterdam

Identifiers

NCT: NCT06731309 · EMCD_12304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗