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

Primary Purpose

Skin Disease, Bacterial, Abscess

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trimethoprim-Sulfamethoxazole
Sponsored by
Lucy Holmes, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Disease, Bacterial focused on measuring Methicillin resistent Staphylococcus aureus, Staphylococcus aureus

Eligibility Criteria

3 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Women & Children's Hospital of Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

10 days of Trimethoprim-Sulfamethoxazole

3 days of Trimethoprim-Sulfamethoxazole

Arm Description

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 26, 2013
Last Updated
September 17, 2015
Sponsor
Lucy Holmes, MD
Collaborators
New York State Department of Health, Women & Children's Hospital of Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT02024867
Brief Title
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
Official Title
Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lucy Holmes, MD
Collaborators
New York State Department of Health, Women & Children's Hospital of Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Disease, Bacterial, Abscess
Keywords
Methicillin resistent Staphylococcus aureus, Staphylococcus aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 days of Trimethoprim-Sulfamethoxazole
Arm Type
Active Comparator
Arm Description
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
Arm Title
3 days of Trimethoprim-Sulfamethoxazole
Arm Type
Experimental
Arm Description
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
Intervention Type
Drug
Intervention Name(s)
Trimethoprim-Sulfamethoxazole
Other Intervention Name(s)
Septra, Bactrim
Intervention Description
3 versus 10 days of drug
Primary Outcome Measure Information:
Title
Treatment Failures
Description
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.
Time Frame
up to 2 weeks after surgical drainage
Title
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Description
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.
Time Frame
up to 2 weeks after surgical drainage
Title
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Description
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.
Time Frame
up to 2 weeks after surgical drainage
Secondary Outcome Measure Information:
Title
Recurrent Skin Infections
Description
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.
Time Frame
1 month after surgical drainage
Title
Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Description
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.
Time Frame
1 month after surgical drainage
Title
Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Description
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.
Time Frame
1 month after surgical drainage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy C Holmes, MD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard Faden, MD
Organizational Affiliation
University at Buffalo
Official's Role
Study Chair
Facility Information:
Facility Name
Women & Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19409657
Citation
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.
Results Reference
background
PubMed Identifier
20346539
Citation
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.
Results Reference
background
PubMed Identifier
26578074
Citation
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.
Results Reference
derived

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

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