Surgicel JME reprint


Catalog excerpts

Surgicel JME reprint - 1

SURGICEL® Family of Absorbable Hemostats• • World’s most trusted brand of absorbable hemostats• • Over 50 years of proven safety and efficacy• Reduction in hospital costs and resource consumption associated with the use of advanced topical hemostats during inpatient procedures • Proven bactericidal activity in vitro against the top 5 pathogens associated with hospital-acquired infections6-8 MRSE SURGICEL SNoW™ Absorbable Hemostat •• Derek Martyn, Richard Kocharian, Sangtaeck Lim, Lisa M Meckley, Gavin Miyasato, Katerina Prifti, Yajing Rao, Jerome Riebman, Jillian Scaife, Yogesh Soneji, Mitra Corral • Superior hemostatic performance compared to SURGICEL® Original Absorbable Hemostat– •• Journal of Medical Economics, 2015; e-publication. March 2, 2015. (doi:10.3111/13696998.2015.1017503) – 43% faster to hemostasis; more effective than 4 layers of SURGICEL® Original4• • Better conformity and adherence to bleeding sites than SURGICEL® Original9,10• • Uniquely structured fibers do not stick to instruments—for ease of use in both open and minimally invasive procedures11 •• RK, SL, JR, and MC are all shareholders of Johnson & Johnson and employees of Ethicon, Inc. DM, LM, GM, KP, YR, JS, and YS are all consultants for Johnson & Johnson. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose. SURGICEL® FIBRILLAR™ Absorbable Hemostat •• This study was funded by Ethicon, Inc. • Superior hemostatic performance compared to SURGICEL® Original– Reduced resource utilization and hospital costs with SURGICEL® FIBRILLAR™ and SURGICEL SNoW™ Absorbable Hemostats was observed with this study. – 39% faster to hemostasis, more effective than 4 layers of SURGICEL® Original4• • Lightweight layered construction is customizable10,12• • “Melts into” bleeding tissue and conforms to irregular surfaces10,12 SURGICEL Essential Product Information INDICATIONS • SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™ and SURGICEL® NU-KNIT® Hemostats can be cut to size for use in endoscopic procedures. PRECAUTIONS Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction. In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product. Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals. If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped. Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.) Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions). ADVERSE EVENTS “Encapsulation” of fluid and foreign body reactions have been reported. There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery. Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was placed in the anterior cranial fossa. Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported. For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012. References: 1. Stokes M, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow M, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Services Research. 2011;11:135. 2. Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814. 3. Zhang G. Comparison of hemostatic performance of SURGICEL absorbable hemostatic products. 2011. Ethicon, Inc. 4. Hutchinson RW, George K, Johns D, Craven L, Zhang G, Shnoda P. Hemostatic efficacy and tissue reaction of oxidized regenerated cellulose hemostats. Cellulose. 2013; 20(1): 537-545. 5. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behavioral Research. 2011; 46: 399-424. 6. Surgicel Brand Absorbable Hemostats [package insert]. Somerville, NJ: Ethicon, Inc. 2010. 7. Spangler D, Rothenburger S, Nguyen K, Jampani H, Weiss S, Bhende S. In vitro antimicrobial activity to oxidized regenerated cellulose against antibiotic-resistant microorganisms. Surg Infect (Larchmt). 2003;4(3):255-262. 8. Dineen P. The effect of oxidized regenerated cellulose on experimental infected splenotomies. J Surg Res. 1977;23(2):114-125. 9. Helms J. VOC Final Report. Ethicon, Inc. 10. SURGICEL Technical Report. October 18, 2013. Ethicon, Inc. 11. Achneck HE, Sileshi B, Jamiolkowski RM, Albala DM, Shapiro ML, Lawson JH. A comprehensive review of topical hemostatic agents: efficacy and recommendations for use. Ann Surg. 2010;251(2):217-228. 2010. 12. Amar AP, Levy ML. Applications of topical hemostatic agents in neurosurgery. Contemp Surg. 1996;4(6):1-4. ©2018 Ethicon US, LLC. All rights reserved. 033783-180712 After controlling for patient characteristics and hospital factors, the use of SURGICEL® FIBRILLAR™ and SURGICEL SNoW™ was associated with lower health care resource utilization and hospital costs compared to SURGICEL® Original Conclusion • Up to 38% lower transfusion costs • Up to 18% shorter ICU stay• • Up to 20% lower ICU costs• • Up to 16% reduction in LOS• • Up to 25% lower hemostatic product usage• All-cause costs defined:• Brain/cerebral 0 $10,000 *All-cause costs defined are the total cost for each hospitalization as abstracted from the dataset directly supplied by the hospital. SURGICEL® FIBRILLAR™ and SURGICEL® SNoW™ SURGICEL® Original Mean All-Cause Costs per Discharge Mean All-Cause Costs per Discharge Up to 18% lower all-cause costs* SURGICEL® FIBRILLAR™ and SURGICE SURGICEL® Original

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