Conservative Management of Cutaneous Abscess

Phase 4

Withdrawn

• Conditions: Cutaneous Abscess
• Interventions: Drug: LMX 4 Topical Cream

• Registration Number: NCT05461053
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Cutaneous abscesses are a common problem in the pediatric population, leading to a substantial number of emergency room and primary care visits each year. Historically, treatment consisted of antibiotics and surgical drainage, but as our understanding of these disease processes has progressed, treatment has moved away from invasive drainage procedures except when necessary. Now, most patients are treated with warm compresses or warm baths to the area until spontaneous resolution occurs. Recent data has demonstrated that the application of topical anesthetic cream to a cutaneous abscess underneath a non-permeable dressing can lead to improved rates of spontaneous drainage. Although this method is being used with success at our institution, its true benefit is unknown, preventing widespread dissemination of the practice. We are therefore proposing a prospective trial to evaluate the benefit of this treatment on pediatric patients. 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.

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMX4-A topical anesthetic application	LMX 4 Topical Cream	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.

Primary Outcome Measures

Name	Time	Method
Time to Spontaneous Discharge	Enrollment + 7-14 Days	Patient/Caregiver will be called to learn date of spontaneous discharge

Secondary Outcome Measures

Name	Time	Method
Rate of Failure	Enrollment + 30 Days	Study team will review medical records for hospital admission, need for incision and drainage, or additional medication treatment

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States