View source for EBQ:TMP-SMX vs Placebo for Uncomplicated Skin Abscess

{{JC info
| title= Trimethoprim–Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess
| abbreviation= Bactrim for Skin Abscesses
| expansion=
| published= March 3, 2016
| author= Talan DA et al. 
| journal= NEJM
| year= 2016
| volume= 374
| issue=9
| pages= 823-832
| pmid= 26962903
| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1507476
| pdfurl=http://www.nejm.org/doi/full/10.1056/NEJMoa1507476
| status=Complete
}}
==Clinical Question==
In settings with MRSA, does [[Trimethoprim-sulfamethoxazole]] treatment after [[Incision and drainage]] of an [[abscess]] result in a greater cure rate?

==Conclusion==
Trimethoprim–sulfamethoxazole treatment resulted in a higher cure rate among patients with a drained cutaneous [[abscess]] than placebo for [[abscess]] that are successfully drained.
==Major Points==
{{Abscess evidence overview}}

==Study Design==
*Multi-Center, Double-Blind RCT
*ED based; sites in Los Angeles, Phoenix, Philadelphia, Baltimore, Kansas City

==Population==
===Patient Demographics===
*Age: 35yo
*Male: 58%
*Days with skin symptoms: 4
*MRSA History: 7%
*Diabetes: 11%
*Abscess Location:
**Head/Neck: 81-89%
**Trunk/Abdomen: 20%
**Groin/buttock: 20%
**Arms/hands: 23%
**Legs/feet: 21%
*Abscess size: 2.5 X 2.0 X 1.5 cm

===Inclusion Criteria===
*Age >12 years of age 
*Cutaneous lesion that was:
**Either suspected to be an [[abscess]] on the basis of physical examination or
**Confirmed via ultrasonography AND
**Found to have purulent material on after I&D proration
*Abscess for less than 1 week
*Size of at least 2.0 cm in diameter (measured from boarder to border) 
*Deemed to be eligible for outpatient treatment per the ED physician

===Exclusion Criteria===
* Suspected osteomyelitis or septic arthritis
* Diabetic foot, decubitus, or ischemic ulcer
* Mammalian bite
* IVDU
* Long-term care residence
* Incarceration
* Immunodeficiency (i.e. ANC <500/mm3)
* Immunosuppressive drugs
* Active chemotherapy
* Known AIDS
* Creatinine clearance <50mL/min
* Taking warfarin, phenytoin, or methotrexate
* Pregnant or lactating

==Interventions==
*Intervention Group: 7 days [[TMP/SMX]] single strength (80mg TMP-400mg SMX) 4 tabs twice daily
*Control Group: Placebo

==Outcomes==
 

===Primary Outcome===
'''Clinical cure of the [[abscess]] lesion at 'test of cure' visit 7-14 days after the end of the treatment period''
*Intention to treat analysis (p=0.005):
**TMP/SMX Group: 80.5%
**Placebo Group: 73.6%
*Per Protocol analysis (p<.001):
**TMP/SMX Group: 92.9%
**Placebo Group: 85.7%

===Secondary Outcomes===
*New skin infection at different site:
**TMP/SMX group: 3.1%
**Placebo group: 10.3%
*Recurrent skin infection at [[abscess]] site:
**TMP/SMX group: 2.1%
**Placebo group: 3.0%

===Subgroup analysis===
 
 

==Criticisms & Further Discussion==
*The results of this study are only generalizable to the study population where most abscesses measured between 2 – 3 cm. There were however [[abscess]] >5cm with surrounding cellulitis where antibiotics are traditionally perscribed
*The [[number needed to treat]] to cure an [[abscess]] is 14 for TMP/SMX use 
*Only 64.7% of the treatment group was 100% adherent with 17.2% being 76 – 99% adherent which make the results especially applicable to the ED population and giving a good estimate of actual patient adherence.
*Although [[TMP/SMX]] is not without side effect, no evidence of [[SJS]] was found in the study population.
*The cure rate was > 80% in the placebo group demonstrating the importance of adequate [[I&D]]
*Prior evidence, although possibly underpowered, had not found a statistical difference in cure rates but did confirm the finding of reduced formation of subsequent lesions.<ref>Schmitz GR et al. 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.</ref>

==External Links==
*[http://emcrit.org/emnerd/case-pragmatic-wound/ EMNerd Case of the Pragmatic Wound]
*[http://www.emlitofnote.com/2016/03/are-antibiotics-back-in-favor-for.html Are Antibiotics Back in Favor for Abscesses?]

==See Also==
*[[Abscess]]
*[[I&D]]

==Funding==
Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00729937

==References==
<references/>

[[Category:EBQ]]