Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Terminated

Conditions

Abscess

Treatments

Drug: Sugar pill
Drug: Trimethoprim-sulfamethoxazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00867789
0810-162

Details and patient eligibility

About

The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

Enrollment

140 patients

Sex

All

Ages

3 months to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 3 months to 17 years
  • Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
  • Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion criteria

  • Signs of systemic illness or ill-appearing, as determined by the treating physician
  • Admission to the hospital following treatment in the Emergency Department
  • Known sulfa allergy
  • Immunocompromised patients
  • Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
  • Previous antibiotic use (for any reason) in the past seven days
  • Non-English speaking patients and families

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

140 participants in 2 patient groups, including a placebo group

Trimethoprim-sulfamethaxazole
Experimental group
Description:
Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
Treatment:
Drug: Trimethoprim-sulfamethoxazole
Sugar pill
Placebo Comparator group
Description:
Incision and drainage of the abscess and treatment with oral placebo (100 patients)
Treatment:
Drug: Sugar pill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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