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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00691600
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abscess	Drug: oral trimethoprim/sulfamethoxazole; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Abscess Resolution [10 days]

   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

Secondary Outcome Measures

1. Number of Participants Requiring Admission for Failure of Abscess Resolution [10 days]

   Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage

2. Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve [10 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 90 Days to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Cruz, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00691600
• Other Study ID Numbers: H-18758
• First Posted: Jun 5, 2008
• Last Update Posted: Jul 1, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Andrea Cruz, Principal Investigator, Baylor College of Medicine: abscess; Abscesses in the pediatric emergency population
• Additional relevant MeSH terms: Abscess; Trimethoprim; Sulfamethoxazole

Study Results

Participant Flow

Arm/Group Title	Antibiotic Arm	Placebo Arm
Arm/Group Description	subjects with abscesses less than 5cm will be randomized to oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days	Patients with abscesses < 5cm randomized to placebo tablets or suspension twice a day for 10 days
Period Title: Overall Study
STARTED	12	11
COMPLETED	12	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oral Trimethoprim/Sulfamethoxazole	Placebo After Incision and Drainage	Total
Arm/Group Description	subjects with abscesses less than 5cm will be randomized to study medication, oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days	Patients with abscesses less than 5cm will be randomized to receive placebo. Placebo: Placebo capsules every 12 hours for 10 days	Total of all reporting groups
Overall Participants	12	11	23
Age (Count of Participants)
<=18 years	12 100%	11 100%	23 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 41.7%	5 45.5%	10 43.5%
Male	7 58.3%	6 54.5%	13 56.5%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Abscess Resolution
Description	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
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Antibiotic Arm	Placebo Arm
Arm/Group Description	oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days	Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Measure Participants	12	11
Count of Participants [Participants]	11 91.7%	9 81.8%

2. Secondary Outcome

Title	Number of Participants Requiring Admission for Failure of Abscess Resolution
Description	Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antibiotic Arm	Placebo Arm
Arm/Group Description	oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days	Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Measure Participants	12	11
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve
Description	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
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antibiotic Arm	Placebo Arm
Arm/Group Description	oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days	Receipt of placebo in either capsule or suspension formulation twice daily for 10 days
Measure Participants	12	11
Count of Participants [Participants]	1 8.3%	2 18.2%

Adverse Events

Arm/Group Title	Antibiotic Arm		Placebo Arm
Arm/Group Description	subjects with abscesses less than 5cm who received oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days		subjects with abscesses less than 5cm who received placebo capsules or suspension every 12 hours for 10 days
All Cause Mortality
	Antibiotic Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Serious Adverse Events
	Antibiotic Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Antibiotic Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.