Antibiotic Therapy After Incision and Drainage for Abscess

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900510
Recruitment Status : Withdrawn (Recruitment of this population in the hospital setting not practical.)
First Posted : May 12, 2009
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Abscess Procedure: Incision and drainage Drug: Trimethoprim/Sulfamethoxazole (Bactrim) Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2009
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Antibiotics

Arm Intervention/treatment
Experimental: Drainage and placebo
Incision and drainage with placebo.
Procedure: Incision and drainage
Drug: Placebo
Active Comparator: Drainage with TMP/SX
Drainage with Bactrim
Drug: Trimethoprim/Sulfamethoxazole (Bactrim)
Trimethoprim/Sulfamethoxazole, oral

Primary Outcome Measures :
  1. Resolution of abscess [ Time Frame: 5-7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900510

United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Thomas Pranikoff, M.D. Wake Forest University Health Sciences

Responsible Party: Wake Forest University Identifier: NCT00900510     History of Changes
Other Study ID Numbers: IRB00008450
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: December 2014

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
subcutaneous abscess
Incision and drainage
Methicillin-resistant staphylococcus aureus

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries
Pathologic Processes
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors