Clinical trial NCT05461053: Conservative Management of Cutaneous Abscess
Official title: A Randomized Controlled Trial for Conservative Management of Cutaneous Abscess Using Topical Anesthetic in Children as Compared to Standard Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cutaneous Abscess
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Spontaneous Discharge
timeFrame: Enrollment + 7-14 Days
Secondary outcomes:
measure: Rate of Failure
timeFrame: Enrollment + 30 Days
Other outcomes:
measure: Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a
timeFrame: Enrollment + 7-14 Days
measure: Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference
timeFrame: Enrollment + 7-14 Days
measure: Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a
timeFrame: Enrollment + 7-14 Days
measure: Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference
timeFrame: Enrollment + 7-14 Days
measure: Global Health PROMIS Pediatric Scale v1.0 - Global Health 7+2
timeFrame: Enrollment + 7-14 Days
measure: Global Health PROMIS Parent Proxy Scale v1.0 - Global Health 7+2
timeFrame: Enrollment + 7-14 Days
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Brian Gulack, MD
role: PRINCIPAL_INVESTIGATOR
References: