Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage

The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Study Overview

• Status: Completed
• Conditions: Abscess; Skin Disease, Bacterial
• Intervention / Treatment: Drug: Trimethoprim-Sulfamethoxazole

Detailed Description

Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14222
      • Women & Children's Hospital of Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
• minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient

Exclusion Criteria:

• patients requiring immediate hospitalization
• patients who have received 2 or more doses of antibiotics in the previous 36 hours
• patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
• patients with a concurrent, non-abscess infection
• patients with an allergy to Trimethoprim-sulfamethoxazole

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 days of Trimethoprim-Sulfamethoxazole; Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day	Drug: Trimethoprim-Sulfamethoxazole; 3 versus 10 days of drug; Other Names: Bactrim; Septra
Experimental: 3 days of Trimethoprim-Sulfamethoxazole; Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day	Drug: Trimethoprim-Sulfamethoxazole; 3 versus 10 days of drug; Other Names: Bactrim; Septra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Failures	Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.	up to 2 weeks after surgical drainage
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus	Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.	up to 2 weeks after surgical drainage
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus	Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.	up to 2 weeks after surgical drainage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Skin Infections	Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.	1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus	Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.	1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus	Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.	1 month after surgical drainage

Collaborators and Investigators

• Sponsor: Lucy Holmes, MD
• Collaborators: Women & Children's Hospital of Buffalo; New York State Department of Health
• Investigators: Principal Investigator: Lucy C Holmes, MD, University at Buffalo; Study Chair: Howard Faden, MD, University at Buffalo

Publications and helpful links

General Publications

• Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. Erratum In: Ann Emerg Med. 2010 Nov;56(5):588.
• Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.
• Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 26, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Methicillin resistent Staphylococcus aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Abscess; Skin Diseases; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; 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; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: DB 2456