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Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Primary Purpose

Abscess

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim-sulfamethoxazole
Sugar pill
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring abscess, outcomes, antibiotics, incision and drainage, skin abscess

Eligibility Criteria

3 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 3 months to 17 years
  • Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
  • Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion Criteria:

  • Signs of systemic illness or ill-appearing, as determined by the treating physician
  • Admission to the hospital following treatment in the Emergency Department
  • Known sulfa allergy
  • Immunocompromised patients
  • Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
  • Previous antibiotic use (for any reason) in the past seven days
  • Non-English speaking patients and families

Sites / Locations

  • Children's Mercy Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trimethoprim-sulfamethaxazole

Sugar pill

Arm Description

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Outcomes

Primary Outcome Measures

Health Outcomes After Use With Trimethoprim-sulfamethaxazole

Secondary Outcome Measures

Full Information

First Posted
March 23, 2009
Last Updated
January 5, 2021
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Blue Cross Blue Shield
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1. Study Identification

Unique Protocol Identification Number
NCT00867789
Brief Title
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
Official Title
Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment due to subjects not meeting inclusion/exclusion criteria
Study Start Date
March 2009 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Blue Cross Blue Shield

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
abscess, outcomes, antibiotics, incision and drainage, skin abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trimethoprim-sulfamethaxazole
Arm Type
Experimental
Arm Description
Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Incision and drainage of the abscess and treatment with oral placebo (100 patients)
Intervention Type
Drug
Intervention Name(s)
Trimethoprim-sulfamethoxazole
Other Intervention Name(s)
Bactrim
Intervention Description
10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
Primary Outcome Measure Information:
Title
Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 3 months to 17 years Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained Diameter of the abscess less than 5cm as measured by the treating physician Exclusion Criteria: Signs of systemic illness or ill-appearing, as determined by the treating physician Admission to the hospital following treatment in the Emergency Department Known sulfa allergy Immunocompromised patients Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal) Previous antibiotic use (for any reason) in the past seven days Non-English speaking patients and families
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan E Giovanni, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17283622
Citation
McCaig LF, McDonald LC, Mandal S, Jernigan DB. Staphylococcus aureus-associated skin and soft tissue infections in ambulatory care. Emerg Infect Dis. 2006 Nov;12(11):1715-23. doi: 10.3201/eid1211.060190.
Results Reference
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PubMed Identifier
4093575
Citation
Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. doi: 10.1016/0736-4679(85)90077-0.
Results Reference
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PubMed Identifier
349218
Citation
Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91. doi: 10.1016/s0361-1124(78)80097-5.
Results Reference
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PubMed Identifier
322789
Citation
Macfie J, Harvey J. The treatment of acute superficial abscesses: a prospective clinical trial. Br J Surg. 1977 Apr;64(4):264-6. doi: 10.1002/bjs.1800640410.
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PubMed Identifier
3720656
Citation
Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42. No abstract available.
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PubMed Identifier
6444142
Citation
Llera JL, Levy RC, Staneck JL. Cutaneous abscesses: natural history and management in an outpatient facility. J Emerg Med. 1984;1(6):489-93. doi: 10.1016/0736-4679(84)90002-7.
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PubMed Identifier
3880635
Citation
Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
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Citation
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Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

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