HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT

NCT ID: NCT06731309

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-04-30

Brief 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.

Conditions

Hidradenitis Suppurativa (Acne Inversa)

Keywords

punch biopsy tool; drainage; abscess; I&D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Punch Debridement

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Incision and Drainage

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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 performed in acute settings by dermatologists, emergency department physicians and general practitioners

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hessel H van der Zee, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Central Contacts

Hessel H van der Zee, MD, PhD

Role: CONTACT

Phone: +31 10 704 0110

Email: h.vanderzee@erasmusmc.nl

Facility Contacts

Hessel H van der Zee

Role: primary

Other Identifiers

EMCD_12304

Identifier Type: -

Identifier Source: org_study_id