HS ABSCESSES: I&D VS PUNCH DEBRIDEMENT

NCT06731309 | Not Yet Recruiting

• 1 other identifier: EMCD_12304
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Recurrence rate in percentage of abscesses recurring after drainage

  1 month

Study Arms (2)

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.

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.

Procedure: Incision and Drainage

Interventions

Punch Debridement 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.

Punch Debdridement

Incision and Drainage 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

Gold standard: Incision and Drainage

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, Netherlands

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Abscess

Interventions

Drainage

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Hessel H van der Zee, MD, PhD

CONTACT

+31 10 704 0110; h.vanderzee@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: RCT with two intervention groups, one of which is gold standard intervention

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: February 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

NL (1)