Let’s discuss the emerging wound taxonomies and new Food and Drug Administration (FDA) guidelines used for testing the efficacy of antibiotics in treating patients with soft tissue infections. Consideration must be given to the health–related quality of life indicators for patients with extremity soft tissue infections who are taking antibiotics.
Complicated skin and skin structure infections are commonly known as cSSSIs. However, for research efficacy purposes, in 2010 the FDA introduced a new classification known as acute bacterial skin and skin structure infections (ABSSSIs).1 The FDA introduced the nomenclature of ABSSSIs to provide a structural anatomic and a systemic basis for evaluating the effectiveness of antibiotics in the treatment of soft tissue infections and wounds. The major clinical difference between the old nomenclature, cSSSIs, and the new ABSSSI nomenclature is a minimum surface area and the correlation of local and systemic indications of infection. The FDA designation of ABSSSI includes extensive cellulitis/erysipelas, wound infections, major cutaneous abscesses, infected burns accompanied by redness, edema, and/or induration of a minimum surface area of 75 sq cm, accompanied by lymph node enlargement or systemic symptoms such as fever 38° C (100.4° F) or greater.1 This classification will provide a basis for measuring the clinical effectiveness of new antibiotics. These particular wound outcome parameters can be followed with the precision of time sequential photography and real-time electronic medical records in a prospective manner. Although classifications and clinical taxonomies help clinicians make inferences about the effect of our treatment, we still need clinical guidelines that maintain the standard of care at the point of service.
New Clinical Guidelines
In February 2011, the Infectious Diseases Society of America published its first clinical practice guidelines for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in children and adults.2–4 The clinical practice guidelines address the management of clinical syndromes associated with MRSA disease, including skin and soft tissue infections. From a clinical epidemiological point of view, the most common pathogen associated with morbidity and mortality from ABSSSIs remains MRSA. “It is the predominant etiology of both healthcare-associated and community-associated infections.”3,4 It is the prevalent cause of skin infections among patients presenting to the emergency department2–4 and can also cause more serious, invasive infections that account for about 18,000 deaths in the United States per year.2–4 MRSA and streptococci continue to be the main organisms in skin and soft tissue infections. Streptococcal infections are associated with both community-acquired and healthcare-acquired infections and without early recognition; streptococcal ABSSSIs can progress to necrotizing fasciitis, in about 25% of the cases, leading to morbidity and mortality.5
A Cautionary Tale
Do not indiscriminately prescribe antibiotics. Do not use them unless there is a very specific reason or a definite pathogen identified. If you use powerful antibiotics for the treatment of ABSSSIs, you must consider the acronym ADD: Age-drug interactions, Disease-drug interactions, and Drug-drug interactions. This mnemonic is a reminder that the prescription of antibiotics is a serious undertaking and that patient safety is paramount.
Richard “Sal” Salcido, MD
1. FDA Guidance. Guidance for industry: acute bacterial skin and skin structure infections: developing drugs for treatment. Draft Guidance. Federal Register: August 27, 2010 (Volume 75, Number 166), http://edocket.access.gpo.gov/2010/2010-21328.htm
. Last accessed January 26, 2012.
4. Liu C, Bayer A, Cosgrove SE, et al.. Infectious Diseases Society of America. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children [published correction appears in Clin Infect Dis 2011;53(3):319]. Clin Infect Dis 2011; 52 (3): e18–55.
5. Salcido RS. Necrotizing fasciitis: reviewing the causes and treatment strategies. Adv Skin Wound Care 2007; 20: 288–93.