Conservative Management of Cutaneous Abscess

A Randomized Controlled Trial for Conservative Management of Cutaneous Abscess Using Topical Anesthetic in Children as Compared to Standard Management

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 Overview

• Status: Withdrawn
• Conditions: Cutaneous Abscess
• Intervention / Treatment: Drug: LMX 4 Topical Cream

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Warm Compress application; 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.
Experimental: LMX4-A topical anesthetic application; 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; 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.; Other Names: lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Spontaneous Discharge	Patient/Caregiver will be called to learn date of spontaneous discharge	Enrollment + 7-14 Days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a	PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better	Enrollment + 7-14 Days
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference	PROMIS Pediatric Item Bank v2.0 - Pain Interference, range 20-100, lower score better	Enrollment + 7-14 Days
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a	PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better	Enrollment + 7-14 Days
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference	PROMIS Parent Proxy Item Bank v2.0 - Pain Interference, range 13-65, lower score better	Enrollment + 7-14 Days
Global Health PROMIS Pediatric Scale v1.0 - Global Health 7+2	PROMIS Pediatric Scale v1.0 - Global Health 7+2, range 9-45, lower score better	Enrollment + 7-14 Days
Global Health PROMIS Parent Proxy Scale v1.0 - Global Health 7+2	PROMIS Parent Proxy Scale v1.0 - Global Health 7+2, range 9-45, lower score better	Enrollment + 7-14 Days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Brian Gulack, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Skin Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 21120103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No