Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

NCT ID: NCT00691600

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-04-30

Brief Summary

The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.

Detailed Description

This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.

Primary outcome:

1. Abscess resolution by parental report 7-10 days after incision and drainage

Secondary outcomes:

1. Admission to the hospital because of worsening infection

2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)

Conditions

Abscess

Study Design

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

Study Groups

oral trimethoprim/sulfamethoxazole

subjects with abscesses less than 5cm will be randomized to either study med or placebo

Group Type: ACTIVE_COMPARATOR

oral trimethoprim/sulfamethoxazole

Intervention Type: DRUG

80 mg caps or 8 mg/ml suspension every 12 hours for 10 days

placebo

Placebo after incision and drainage of abscess less than 5 cm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo caps or suspension every 12 hours for 10 days

Interventions

oral trimethoprim/sulfamethoxazole

80 mg caps or 8 mg/ml suspension every 12 hours for 10 days

Intervention Type: DRUG

Placebo

Placebo caps or suspension every 12 hours for 10 days

Intervention Type: DRUG

Other Intervention Names

TMP/SMX; Placebo caps

Eligibility Criteria

Inclusion Criteria

1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

Exclusion Criteria

1. Multiple abscesses

2. Abscess located on the hands, face, or perineum

3. Abscess as a result of a bite wound

4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.

5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX

7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.

9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.

• Minimum Eligible Age: 90 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Andrea Cruz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Cruz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

H-18758

Identifier Type: -

Identifier Source: org_study_id