Antibiotic Therapy After Incision and Drainage for Abscess

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00900510
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Abscess
Procedure: Incision and drainage
Drug: Trimethoprim/Sulfamethoxazole (Bactrim)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Resolution of abscess [ Time Frame: 5-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drainage and placebo
Incision and drainage with placebo.
Procedure: Incision and drainage Drug: Placebo
Active Comparator: Drainage with Trimethoprim/Sulfamethoxazole
Drainage with Bactrim
Procedure: Incision and drainage Drug: Trimethoprim/Sulfamethoxazole (Bactrim)
Trimethoprim/Sulfamethoxazole, oral

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900510

Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Thomas Pranikoff, M.D. Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Thomas Pranikoff, M.D., Wake Forest Uinversity School of Medicine
ClinicalTrials.gov Identifier: NCT00900510     History of Changes
Other Study ID Numbers: IRB00008450
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
subcutaneous abscess
Incision and drainage
Methicillin-resistant staphylococcus aureus

Additional relevant MeSH terms:
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration
Sulfamethoxazole
Trimethoprim
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014