Retrospective Study Shows SURGICEL® Family of Topical Absorbable Hemostats Decreases Hospital Resource Use and Lowers Associated Costs

HOUSTON, Sept. 15, 2014 /PRNewswire/ -- Ethicon, Inc. announced results of a large, retrospective study that showed the use of the SURGICEL^® Family of Topical Absorbable Hemostats was associated with lower costs, reduced product usage, shortened length of hospital stay, and reduced transfusions compared to the use of other adjunctive hemostats.¹ The study was presented at the Society for the Advancement of Blood Management annual meeting in Houston, Texas.

The study results suggest that hospitals may improve patient outcomes and limit the overall cost of treatment by making the appropriate selection of hemostatic agents to minimize blood loss and potentially prevent complications from re-bleeding during surgery.

Hard-to-control, poorly controlled and uncontrolled bleeding in the surgical setting can have severe consequences, such as transfusions, increased length of stay and up to a 93 percent increase in costs.² Adjunctive hemostats are typically utilized to reduce or prevent surgical bleeding, and over time, the use of hemostatic agents has increased for all surgical procedures.³

"During the last 50 years, the SURGICEL^® Family of Hemostats has consistently proven to be safe and effective with superb absorbability and in vitro bactericidal properties," said Jerome Riebman, M.D., director, Medical Affairs at Ethicon. "This study adds to the growing body of evidence that suggests the SURGICEL^® Family of Topical Absorbable Hemostats has the potential to reduce burdens associated with bleeding and bleeding-related complications, which translate into cost and resource use savings for health care providers."

In June, a different study presented at the International Society on Thrombosis and Haemostasis showed that the use of advanced SURGICEL^® products (SURGICEL^® FIBRILLAR™ and SURGICEL^® SNOW™) was associated with lower costs, reduced product usage, reduced length of hospital stay and reduced units of blood transfusions compared to SURGICEL^® Original. These data provide further evidence of the efficacy of the SURGICEL^® Family of Products, as well as its potential to positively impact patient outcomes and hospital resource use and cost.

Used in more than 100 million procedures, SURGICEL^® ORIGINAL is considered to be the gold-standard comparator in topical absorbable hemostat clinical trials.^4,5 Designed to meet evolving surgical needs, our advanced SURGICEL^® FIBRILLAR™ and SURGICEL^® SNOW™ brands enable surgeons to do more in the operating room while saving more.

The SURGICEL^® Family of Hemostats are the first and only absorbable hemostats in the United States with proven bactericidal properties against more strains of bacteria than any other cellulose-based topical adjunctive hemostat, including various antibiotic-resistant bacteria (MRSA, VRE, PRSP and MRSE).^6,7 Only SURGIGEL^® Absorbable Hemostats demonstrate consistent bactericidal activity in vitro against the top five pathogens commonly reported to cause surgical site infections.

Read more at www.surgicel.com.

About the Study
The study was a retrospective, database analysis of Cholecystectomy, Cardiovascular (including Value Surgery and Coronary Artery Bypass Graft), Hysterectomy and Carotid Endarterectomy procedures from the Premier Hospital Database. It compared healthcare resource utilization (HCRU), costs and outcomes associated with the use of the SURGICEL^® Family of Products (SURGICEL^® ORIGINAL, SURGICEL^® NU-KNIT^®, SURGICEL^® FIBRILLAR™, SURGICEL^® SNOW™) to health outcomes and HCRU associated with other adjunctive hemostats (e.g. flowables, gelatin and thrombin).

Adult patients (18 years of age or older) with a hospitalization discharge from the Premier Research Database between January 1, 2011 and December 31, 2012 were evaluated.

The study showed that the use of the SURGICEL^® Family of Topical Absorbable Hemostats across the four procedures was associated with a cost-savings of $71-155 per procedure, which resulted in a decrease of 33-59 percent of hemostat cost.

Additionally, in Cholecystectomy procedures, the overall cost of treatment was reduced by 14 percent, hemostat usage was reduced by 18 percent, average hospital stay was reduced by 12 percent, and transfusions were reduced by 18 percent. In Endarterectomy procedures, hemostat usage was reduced by 41 percent, and transfusions were reduced by 18 percent.

Study Limitations
All observational, retrospective studies of secondary data have inherent limitations. Not all of the factors that influence a physician's choice of products to treat specific patients are available in the dataset. However, PSMs were used to create similar groups for comparison. While PSMs cannot control for unmeasured characteristics and thus is less powerful than randomization, on the basis of observable characteristics, the patient populations were similar. There are also limitations to the Premier chargemaster data. The data may not capture all hospital readmissions and do not include complete outpatient data. However, these limitations are not relevant to the current study since all outcomes measured occurred during the hospital stay and did not include physician office visits. Additionally, it is unclear whether treatment patterns and outcomes differ between Premier hospitals and non-Premier hospitals and whether these hospitals are representative, although these results are most likely generalizable to many patients across the US as approximately 25 percent of all hospital discharges are from a Premier hospital. Finally, as with all claims and chargemaster data, coding errors or omitted procedure/product codes could lead to misclassification of patients and potential bias in the results.

About Ethicon
Part of the Johnson & Johnson Family of Companies, Ethicon offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars, hemostats, synthetic mesh devices and energy devices—that are used in a variety of minimally invasive and open surgical procedures. Specialties include support for the treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. Founded more than 80 years ago, our Ethicon business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are headquartered in Somerville, New Jersey, and Cincinnati, Ohio, respectively. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

¹ Corral, M, et al. Variation in hospital resource use and cost with the use of currently available topical absorbable hemostats in surgical procedures. Society for the Advancement of Blood Management Annual Meeting, Houston, TX, USA, September 11-13, 2014.
² Stokes M et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Services Research. 2011;11(1):135.
³ Corral, M, et al. Hospital Resource Use and Cost Reduction with the Use of Advanced Topical Absorbable Hemostats in Surgical Procedures. 60th Scientific and Standardization Committee meeting of the International Society on Thrombosis and Haemostasis, Milwaukee, WI, USA, June 23 - 26, 2014.
⁴ Hong YM, Loughlin KR. The use of hemostatic agents and sealants in urology. J Urol. 2006;176(6 Pt 1):2367-2374.
⁵ Data on file, Ethicon, Inc. Strive Data
⁶ Spangler D et al. In vitro antimicrobial activity of oxidized regenerated cellulose against antibiotic-resistant microorganisms.Surg Infect. 2003;4(3):255-262.
⁷ Data on file, Ethicon, Inc. In Vitro Study

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SOURCE Ethicon, Inc.