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Conservative Management of Cutaneous Abscess

Primary Purpose

Cutaneous Abscess

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LMX 4 Topical Cream
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Abscess

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Warm Compress application

LMX4-A topical anesthetic application

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Failure
Study team will review medical records for hospital admission, need for incision and drainage, or additional medication treatment

Full Information

First Posted
July 6, 2022
Last Updated
October 19, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05461053
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Warm Compress application
Arm Type
No Intervention
Arm Description
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.
Arm Title
LMX4-A topical anesthetic application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LMX 4 Topical Cream
Other Intervention Name(s)
lidocaine
Intervention Description
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 Measure Information:
Title
Time to Spontaneous Discharge
Description
Patient/Caregiver will be called to learn date of spontaneous discharge
Time Frame
Enrollment + 7-14 Days
Secondary Outcome Measure Information:
Title
Rate of Failure
Description
Study team will review medical records for hospital admission, need for incision and drainage, or additional medication treatment
Time Frame
Enrollment + 30 Days
Other Pre-specified Outcome Measures:
Title
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a
Description
PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better
Time Frame
Enrollment + 7-14 Days
Title
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference
Description
PROMIS Pediatric Item Bank v2.0 - Pain Interference, range 20-100, lower score better
Time Frame
Enrollment + 7-14 Days
Title
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a
Description
PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better
Time Frame
Enrollment + 7-14 Days
Title
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference
Description
PROMIS Parent Proxy Item Bank v2.0 - Pain Interference, range 13-65, lower score better
Time Frame
Enrollment + 7-14 Days
Title
Global Health PROMIS Pediatric Scale v1.0 - Global Health 7+2
Description
PROMIS Pediatric Scale v1.0 - Global Health 7+2, range 9-45, lower score better
Time Frame
Enrollment + 7-14 Days
Title
Global Health PROMIS Parent Proxy Scale v1.0 - Global Health 7+2
Description
PROMIS Parent Proxy Scale v1.0 - Global Health 7+2, range 9-45, lower score better
Time Frame
Enrollment + 7-14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Gulack, MD
Phone
3129425500
Email
brian_gulack@rush.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Alecci
Phone
3129421614
Email
anna_t_alecci@rush.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Gulack, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Gulack, MD

12. IPD Sharing Statement

Learn more about this trial

Conservative Management of Cutaneous Abscess

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