Ortho-McNeil Launches Skin Infection Registry

RARITAN, N.J. — The nation’s first, prospective registry of complicated skin and soft tissue infections (cSSTIs), known as the Skin and Soft Tissue Infection Hospital Registry (SSTIR), has begun enrolling patients. The SSTIR, plans to enroll more than 1,200 hospitalized patients by the end of this year, and is designed to better understand treatment patterns and provide data to help improve patient outcomes. The registry is sponsored by Ortho-McNeil, division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

More than 50 hospitals nationwide will participate in this prospective, multi-center registry, which will comprehensively characterize the four major types of cSSTIs: diabetic foot infections, surgical site infections, deep soft tissue abscesses and cellulitis (an infection of tissue under the skin). In addition, the study will observe patient management in the hospital setting, including selection and timing of antibiotic treatment, changes in treatment regimen, outcomes, and economic impact.

“Physicians are treating more and more patients with complicated skin infections in hospitals across the U.S., and the emergence of resistant pathogens has made the situation even more complex,” said Susan Nicholson, MD, therapeutic area leader for internal medicine at Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. “This data will give physicians insight into how to manage these difficult-to-treat infections and understand current treatment patterns in order to provide consensus on how best to care for patients.”

Complicated skin and soft tissue infections account for almost 10 percent of all hospital admissions in the U.S.[1] The most common types of cSSTIs are post-operative surgical site infections, which represent up to 25 percent of all hospital infections. Cellulitis and soft tissue abscesses are among the most common reasons for emergency department visits.[2, 3]

According to the National Institutes of Health, 111,000 people with diabetes are hospitalized with foot infections each year, and as many as 3.09 million adults will develop a diabetic foot infection in their lifetime.[4-5]

The increased incidence of one of the most common resistant bacteria that are causing cSSTI, methicillin-resistant Staphylococcus aureus (MRSA), poses a significant challenge and burden to the U.S. healthcare system.  Despite the high incidence of cSSTIs, a limited understanding remains and a wide variety of treatment options are used which often affect patient outcomes.  

The emergence of resistant bacteria has created a need for new antibiotics and treatment strategies. As such, treatment choices made by physicians can significantly impact how patients with cSSTI respond to care.

More information on the SSTIR, including a listing of enrolling sites, can be obtained by calling Myoung S. Kim, PhD, director of outcomes research, at (908) 218-6419.


1. DiNubile MJ, Lipsky BA. Complicated Infections of Skin and Skin Structures: when the infection is more than skin deep. JAC. 2004;53

2. Nichols RL, Florman S. Clinical presentations of soft-tissue infections and surgical site infections. Clin Infect Dis 2001. 33 Suppl 2: S84-S93.

3. Stevens DL, et al., Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections IDSA Guidelines, CID 2005 41:1373-1406.

4. Centers for Disease Control and Prevention, National Diabetes Fact Sheet, United States 2005, General Information. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed 01.15.08

5. Boulton AJM, Armstrong DG. 2003. Trials in Neuropathic Diabetic Foot Ulceration. Diabetes Care. 26; 9:2689-2690

Source: Ortho-McNeil