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

Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.

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.

Study Overview

• Status: Completed
• Conditions: Abscess
• Intervention / Treatment: Drug: oral trimethoprim/sulfamethoxazole; Drug: Placebo

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)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: oral trimethoprim/sulfamethoxazole; subjects with abscesses less than 5cm will be randomized to either study med or placebo	Drug: oral trimethoprim/sulfamethoxazole; 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days; Other Names: TMP/SMX
PLACEBO_COMPARATOR: placebo; Placebo after incision and drainage of abscess less than 5 cm.	Drug: Placebo; Placebo caps or suspension every 12 hours for 10 days; Other Names: Placebo caps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abscess Resolution	Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Requiring Admission for Failure of Abscess Resolution	Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage	10 days
Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve	For the antibiotic arm, we determined if the child was prescribed a different antibiotic. For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage	10 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Andrea Cruz, MD, MPH, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (ESTIMATE): June 5, 2008

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: abscess; Abscesses in the pediatric emergency population
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Trimethoprim; Sulfamethoxazole
• Other Study ID Numbers: H-18758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO