Conservative Management of Cutaneous Abscess

Cutaneous Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05461053
• Other study ID #: 21120103
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2025
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cutaneous Abscess
• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Time to Spontaneous Discharge	Patient/Caregiver will be called to learn date of spontaneous discharge	Enrollment + 7-14 Days
Secondary	Rate of Failure	Study team will review medical records for hospital admission, need for incision and drainage, or additional medication treatment	Enrollment + 30 Days