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

Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024867
• Other study ID #: DB 2456
• Status: Completed
• Phase: N/A
• First received: December 26, 2013
• Last updated: September 17, 2015
• Start date: February 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2015
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Skin Disease, Bacterial
• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Drug:
• Trimethoprim-Sulfamethoxazole
3 versus 10 days of drug

Locations

Country	Name	City	State
United States	Women & Children's Hospital of Buffalo	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Lucy Holmes, MD	New York State Department of Health, Women & Children's Hospital of Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No