Introduction

Congratulations on your commitment to improving the care of your patients! The goal of the Complicated Skin and Skin Structure Infections (cSSSIs) Resource Room and Implementation Guide is to provide you with the resources you need to bring an approach to quality improve­ment with different cSSSIs. Complicated skin and skin structure infections is a relatively new term whose definition (cSSSIs) was originally organized around a Food and Drug Administration (FDA) guide for industry in developing antimicrobial agents. It was initially published in 1998 as a draft titled Guidance for Industry Uncomplicated and Complicated Skin and Skin Structure Infections — Developing Antimicrobial Drugs for Treatment.¹

The FDA defined uncomplicated skin infections as clinical entities including simple abscesses, im­pe­tiginous lesions, furuncles, and cellulitis. Infections that can be treated by surgical incision alone, such as cases of isolated furunculosis or folliculitis (meaning 1 solitary area of infection), were also classified as uncomplicated.

The complicated category includes infections either involving deeper soft tissue or requiring significant surgical intervention, such as infected ulcers, burns, and major abscesses, or associated with a significant underlying disease state, such as diabetes, which complicates the response to treatment. Superficial infections or abscesses at an anatomical site such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is higher, should also be considered complicated infections.

The FDA recognized that there are clinical situations where it may be difficult to categorize an infection into one of these broad categories. Most common situations were addressed; for example, infections involving prosthetic materials such as tunneled catheter infections were specifically excluded. Although infections with underlying conditions such as immune deficiency or atopic dermatitis were classified as “complicated,” the FDA also suggested excluding these patients from clinical trials under that category because their underlying condition might impair proper evaluation of the anti-infective agent’s effect.

Because the FDA guidelines have been published, literature on cSSSIs as a clinical entity has evolved gradually. As suggested by the FDA, many trials and published results have involved antibiotics. We have not seen further attempts at classifying or categorizing cSSSIs in the literature.

While recognizing that cSSSIs as a group are a significant challenge for the hospitalist, one of the first efforts in a quality improvement project will be to define our goals as specifically as possible. After considering the recommendations from the FDA, the current literature on cSSSIs, and the wide range of clinical problems in cSSSIs, ranging from burns to abscesses, our panel identified the top 3 areas that were believed to be important epidemiologically, economically, and to a hospitalist’s daily practice.

The hallmark of all 3 of these infections is that “an ounce of prevention is worth a pound of cure.”

Diabetic Foot Infections

Diabetic foot infections (DFIs) account for the largest number of diabetes-related hospital bed days2 and account for more hospital days than any other diabetes-related complication. They account for significant morbidity and mortality and are the most common nontraumatic cause of amputations. The cost of foot disease is astounding. Medicare records show that $1.5 billion was spent directly on diabetic foot ulcers from 1995 to 1996.³ As the Infectious Disease Society of America states in its 2004 guidelines, diabetic foot infections are “common, complex, and costly.”⁴

Hospitalists may be the primary care giver or serve as consultants to DFI patients who are admitted to a surgical service. In either case, these patients have multidisciplinary needs that are often both challenging to coordinate and, unfortunately, not done well.⁵

Hospitalists are in a unique position and can be the catalyst in moving the clinical bar higher at their institutions. This implementation guide will provide our readers with all the tools needed to start a quality initiative that we hope will ultimately lead to a lower rate of lower-extremity amputations in this vulnerable population

Stage III and Stage IV Pressure Ulcers

Hospital-acquired pressure ulcers are a “never event,” and yet up to 38% of patients in an acute care setting do acquire them.⁵ The challenges of preventing and treating pressure ulcers reach across the health care spectrum from nursing to nutrition. Hospitalists, as the primary providers for so many high-risk patients, are in a prime position to advocate for positive change. Following the path of this implementation guide will guide the user in creating a multidisciplinary team that will be able to reduce the incidence and prevalence of complicated pressure ulcers at his or her institution, promptly recognize skin breakdown when it does happen, and provide comprehensive treatment to patients with ulcers that become complicated.

Surgical Site Infections

Although at first glance, it may seem as if surgical site infections should be delegated to surgeons, hospitalists often are involved in the care of patients with these infections. The Institute for Healthcare Improvement reports that postoperative infection is a major cause of patient injury, mortality, and health care costs.

• An estimated 2.6% of nearly 30 million operations are complicated by surgical site infections (SSIs) each year.
  
• Infection rates of up to 11% have been reported for certain types of operations.
  
• Each infection is estimated to increase a hospital stay by an average of 7 days and add more than $3,000 in charges (1992 data).

A hospitalist may encounter surgical site infections as a consultant or become the patient’s primary physician in the hospital once the acute surgical issues, other than infection, have resolved. Patients may be transferred to a long-term acute care hospital under a hospitalist’s care, or a hospitalist may have a chance to prevent an infection before the surgery ever starts by assuring correct antibiotic prophylaxis. The care components that reduce surgical site infections have been well studied. Our implementation guide will go over these goals and guide readers in forming teams, mapping out areas in which their institutions have gaps, and implementing solutions specific to their institutions with the goal of reducing rates of surgical site infections at their institutions. As in the case of pressure ulcers, our goal is 100% prevention -but infections will happen and early diagnosis along with appropriate treatment will be important.

Although the details surrounding a quality improvement (QI) effort may vary for each of the diagnoses, the approach and principles of QI remain remarkably similar. If you are not familiar with QI processes, we encourage you to review QI Basics before proceeding.

The implementation guide is built around well-proven principles of quality improvement, personal experiences, and evidence-based medicine. The guide will walk you through the steps involved in collecting information, creating a team, redesigning process, and measuring your results, which can optimize both treatment and outcomes while minimizing complications at your institution.

1. Available at:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071185.pdf. Accessed July 21, 2009.
2. Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13(suppl 1):S6–S11.
3. Harrington C, Zagari MJ, Corea J, et al. A cost analysis of diabetic lower extremity ulcers. Diabetes Care. 2000;23:1333–1338.
4. Available at: http://www.journals.uchicago.edu/doi/pdf/10.1086/424846.
5. Edelson GW, Armstrong DG, Lavery LA, Caicco G. The acutely infected diabetic foot is not adequately evaluated in an inpatient setting. Arch Intern Med. 1996;156:2373–2378.
6. Lyder CH. Pressure ulcer prevention and management. JAMA. 2003;289:223–226.