Antibiotic Therapy After Incision and Drainage for Abscess

NCT ID: NCT00900510

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Abscess

Keywords

subcutaneous abscess; Incision and drainage; Methicillin-resistant staphylococcus aureus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drainage and placebo

Incision and drainage with placebo.

Group Type: EXPERIMENTAL

Incision and drainage

Intervention Type: PROCEDURE

Placebo

Intervention Type: DRUG

Drainage with TMP/SX

Drainage with Bactrim

Group Type: ACTIVE_COMPARATOR

Trimethoprim/Sulfamethoxazole (Bactrim)

Intervention Type: DRUG

Trimethoprim/Sulfamethoxazole, oral

Interventions

Incision and drainage

Intervention Type: PROCEDURE

Trimethoprim/Sulfamethoxazole (Bactrim)

Trimethoprim/Sulfamethoxazole, oral

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pranikoff, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00008450

Identifier Type: -

Identifier Source: org_study_id