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Antibiotic Therapy After Incision and Drainage for Abscess

Primary Purpose

Abscess

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incision and drainage
Trimethoprim/Sulfamethoxazole (Bactrim)
Placebo
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring subcutaneous abscess, Incision and drainage, Methicillin-resistant staphylococcus aureus

Eligibility Criteria

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

Inclusion Criteria:

  • Any child (age 6 months-18 years old) that:

    • does not meet criteria for hospitalization and
    • has only one localized abscess (>/= 2 cm of erythema and induration), which is clinically judged to be amenable to incision and drainage. (i.e., on clinical exam their is fluctuance, erythema, induration, and/or purulent drainage)
    • has an abscess that is ± 7 days from onset, who requires surgical incision and drainage for a skin and soft-tissue abscess

Exclusion Criteria:

  • children < 6 months of age
  • children who require inpatient hospitalization - children with a medical condition in which adjuvant antibiotic therapy would be accepted standard of practice (i.e., history of neutropenia, cardiac surgery, indwelling prosthesis)
  • children with a previously diagnosed immunodeficiency (HIV, Chronic Granulomatous Disease, Job's syndrome, chronic steroid use)
  • children hospitalized within 2 months of presentation (due to higher rate of nosocomial MRSA colonization)
  • abcesses located on the head or neck
  • children with history of a sulfa allergy
  • abscesses caused by animal bite wounds
  • children with Diabetes Mellitus
  • abscesses arising from tattooing
  • abscesses arising from vaccination sites
  • pregnant females

Sites / Locations

  • Wake Forest University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drainage and placebo

Drainage with TMP/SX

Arm Description

Incision and drainage with placebo.

Drainage with Bactrim

Outcomes

Primary Outcome Measures

Resolution of abscess

Secondary Outcome Measures

Full Information

First Posted
May 11, 2009
Last Updated
November 2, 2017
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT00900510
Brief Title
Antibiotic Therapy After Incision and Drainage for Abscess
Official Title
The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment of this population in the hospital setting not practical.
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called "Community-Acquired Methicillin-Resistant Staph Aureus" (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections. Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo? Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
subcutaneous abscess, Incision and drainage, Methicillin-resistant staphylococcus aureus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Drainage and placebo
Arm Type
Experimental
Arm Description
Incision and drainage with placebo.
Arm Title
Drainage with TMP/SX
Arm Type
Active Comparator
Arm Description
Drainage with Bactrim
Intervention Type
Procedure
Intervention Name(s)
Incision and drainage
Intervention Type
Drug
Intervention Name(s)
Trimethoprim/Sulfamethoxazole (Bactrim)
Intervention Description
Trimethoprim/Sulfamethoxazole, oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Resolution of abscess
Time Frame
5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any child (age 6 months-18 years old) that: does not meet criteria for hospitalization and has only one localized abscess (>/= 2 cm of erythema and induration), which is clinically judged to be amenable to incision and drainage. (i.e., on clinical exam their is fluctuance, erythema, induration, and/or purulent drainage) has an abscess that is ± 7 days from onset, who requires surgical incision and drainage for a skin and soft-tissue abscess Exclusion Criteria: children < 6 months of age children who require inpatient hospitalization - children with a medical condition in which adjuvant antibiotic therapy would be accepted standard of practice (i.e., history of neutropenia, cardiac surgery, indwelling prosthesis) children with a previously diagnosed immunodeficiency (HIV, Chronic Granulomatous Disease, Job's syndrome, chronic steroid use) children hospitalized within 2 months of presentation (due to higher rate of nosocomial MRSA colonization) abcesses located on the head or neck children with history of a sulfa allergy abscesses caused by animal bite wounds children with Diabetes Mellitus abscesses arising from tattooing abscesses arising from vaccination sites pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pranikoff, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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