Antibiotic Therapy After Incision and Drainage for Abscess

The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Abscess
• Intervention / Treatment: Drug: Placebo; Procedure: Incision and drainage; Drug: Trimethoprim/Sulfamethoxazole (Bactrim)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resolution of abscess	5-7 days

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Thomas Pranikoff, M.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 11, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Incision and drainage; subcutaneous abscess; Methicillin-resistant staphylococcus aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: IRB00008450