Antibiotic Therapy After Incision and Drainage for Abscess

NCT00900510 | Withdrawn DMC

• 1 other identifier: IRB00008450
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Resolution of abscess

  5-7 days

Study Arms (2)

Drainage and placebo

EXPERIMENTAL

Incision and drainage with placebo.

Procedure: Incision and drainage; Drug: Placebo

Drainage with TMP/SX

ACTIVE COMPARATOR

Drainage with Bactrim

Drug: Trimethoprim/Sulfamethoxazole (Bactrim)

Interventions

Incision and drainage PROCEDURE

Drainage and placebo

Trimethoprim/Sulfamethoxazole (Bactrim) DRUG

Trimethoprim/Sulfamethoxazole, oral

Drainage with TMP/SX

Placebo DRUG

Drainage and placebo

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Abscess; Surgical Wound

Interventions

Drainage; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Thomas Pranikoff, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 6, 2017

Record last verified: 2014-12

Locations

US (1)