NOTE:

Specific indications, limitations, contraindications, warnings, precautions and safety information exist for these products and therapies. Please consult a clinician and product instructions for use prior to application. Rx only.

Limitations :

• The device is not intended to treat surgical site infection or seroma.
• Safety and effectiveness in pediatric population (<22 years old) have not been evaluated.
• Safety and effectiveness in Class III (Contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily, and the subject device should only be used on closed surgical incisions.
• The device has not been demonstrated to reduce deep incisional and organ space surgical site infections.
• The device has not been demonstrated to be effective in reducing the incidence of surgical site infection and seroma in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce the incidence of surgical site infection and seroma.
• Please refer to the ‘Summary of Clinical Information’ section for the specific surgical procedures and patient populations included in the clinical studies. Surgeons should continue to follow the ‘Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection’6 and the ‘American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines’7 for best practices in preventing surgical site infection. US FDA Cleared: Dressings/ Systems (Prevena Dressings used with compatible Solventum NPWT units - ActiVAC, Ulta, and RX4) and applicable OUS countries that leverage US Indication: The PREVENA™, PREVENA PLUS™, PREVENA DUO™, and PREVENA RESTOR™ Incision Management Systems are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

參考文獻：

1. Zimlichman E, Henderson D, Tamir, et al. Health care-associated Infections a meta-analysis of costs and financial impact on the U.S. health care system. JAMA Interned.2013;173(22):20-46. 
2. Magill SS, Edwards JR, Bamberg W, et al. Multistate point-prevalence survey of health care-associated Infections. N Engl JMed: 2014;370:1198-208. 
3. Shepard J, Ward W, Milstone A, et al. Financial impact of surgical site infections on hospitals. The hospital management perspective. JAMA Surg. 2013;148(10):907-914.doi:10.1001/jamasurg.2013.2246 Published online August 21, 2013. 
4. Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003;290(14):1868-1874. 
5. Cooper HJ, Singh DP, Gabriel A, Mantyh C, Silverman R, Griffin L. Closed Incision Negative Pressure Therapy Versus Standard of Care Over Closed Surgical Incisions in the Reduction of Surgical Site Complications: A Systematic Review and Meta-Analysis of Comparative Studies. Plastic and Reconstructive Surgery – Global Open. 2023 Mar 16;11(3):e4722.
6. Berríos-Torres, S. I., Umscheid, C. A., Bratzler, D. W., Leas, B., Stone, E. C., Kelz, R. R., Reinke, C. E., Morgan, S., Solomkin, J. S., Mazuski, J. E., Dellinger, E. P., Itani, K. M., Berbari, E. F., Segreti, J., Parvizi, J., Blanchard, J., Allen, G., Kluytmans, J. A., Donlan, R., & Schecter, W. P. (2017). Centers for Disease Control and Prevention guideline for the prevention of surgical site infection, 2017. JAMA Surgery, 152(8), 784. https://doi.org/10.1001/jamasurg.2017.0904
7. Ban, K. A., Minei, J. P., Laronga, C., Harbrecht, B. G., Jensen, E. H., Fry, D. E., Itani, K. M. F., Dellinger, P. E., Ko, C. Y., & Duane, T. M. (2017). American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 update. Journal of the American College of Surgeons, 224(1), 59–74. https://doi.org/10.1016/j.jamcollsurg.2016.10.029

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