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Antibiotic Therapy After Incision and Drainage for Abscess

NCT00900510 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-06

No results posted yet for this study

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

Interventions

PROCEDURE

Incision and drainage

DRUG

Trimethoprim/Sulfamethoxazole (Bactrim)

Trimethoprim/Sulfamethoxazole, oral

DRUG

Placebo

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Thomas Pranikoff, M.D. · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00900510 on ClinicalTrials.gov