Conservative Management of Cutaneous Abscess

NCT05461053 | Withdrawn Phase 4

• 1 other identifier: 21120103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.

Conditions

Cutaneous Abscess

Outcome Measures

Primary Outcomes (1)

• Time to Spontaneous Discharge

  Patient/Caregiver will be called to learn date of spontaneous discharge

  Enrollment + 7-14 Days

Secondary Outcomes (1)

• Rate of Failure

  Enrollment + 30 Days

Other Outcomes (6)

• Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a

  Enrollment + 7-14 Days

• Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference

  Enrollment + 7-14 Days

• Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a

  Enrollment + 7-14 Days

Study Arms (2)

Warm Compress application

NO INTERVENTION

The control group will receive instructions on applying warm compresses, the current standard of care. The patient or parent/guardian will be directed to apply a warm compress to the abscess or soak the area in warm water for 15 minutes. The application/soak will be done 4 times during the day.

LMX4-A topical anesthetic application

EXPERIMENTAL

The intervention group will be prescribed a course of LMX4 with application of a non-permeable dressing (Tegaderm, 3M, St Paul, MN) until time of spontaneous drainage, treatment failure, or resolve of pain. LMX4 is a topical anesthetic consisting of 4% lidocaine which is Food and Drug Administration (FDA) approved for topical use in children.

Drug: LMX 4 Topical Cream

Interventions

LMX 4 Topical Cream DRUG

The intervention group will be prescribed a course of LMX4 with application of a non-permeable dressing (Tegaderm, 3M, St Paul, MN) until time of spontaneous drainage, treatment failure, or resolve of pain. LMX4 is a topical anesthetic consisting of 4% lidocaine which is Food and Drug Administration (FDA) approved for topical use in children.

Also known as: lidocaine

LMX4-A topical anesthetic application

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \<18 years of age
• Single, localized soft tissue abscess \<3 cm in size by clinical or imaging criteria

You may not qualify if:

• Signs of systemic illness/infection including but not limited to temperature \> 100.4, lethargy, or poor oral intake;
• A decision by an attending physician that incision and drainage is necessary;
• Inpatient admission; immunocompromised patients; soft tissue abscesses involving the perineum (labia, scrotum, penis, perianal), hands/feet, or face;
• Previous antibiotic use in the past seven days or previous attempt by a clinician/provider at drainage;
• Current drainage from abscess.
• Lidocaine allergy

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian Gulack, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)