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3M Prevena Therapy for cardiothoracic surgery

Advancing the standard of care in cardiothoracic surgery

Cardiothoracic surgery patient care extends beyond the operating room (OR). While confidence in the OR is essential, postoperative concerns like infections, swelling and tissue integration can impact recovery. 3M™ Prevena™ Therapy provides you with a proactive strategy for incision care, elevating the standard of postoperative treatment and optimizing the healing environment to enhance your patients' recovery experience.

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Sternum incision with 3M™ Prevena™ Peel and Place System Kit applied. MedPeople_OR_11045
Impact of Prevena Therapy Proactive Risk Management Videos Resources Contact us
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Impact of Prevena Therapy
Proactive Risk Management
Videos
Resources
Contact us

Enhanced cardiothoracic surgery outcomes with Prevena Therapy

A peer-reviewed meta-analysis of 6 studies for cardiac surgical procedures demonstrated 3M™ Prevena™ Therapy helped significantly reduce the risk of surgical site infections (SSIs) compared to standard-of-care dressings.¹

Icon illustration 49.3%
Reduction in SSIs1,*

7 studies; p<0.001† 

Icon illustration 61% with down arrow
Reduction in risk of SSIs in high risk patients1,* 

2 studies; p=0.004† 

*Relative risk reduction.

†Calculation(s) are derived based on the relative patient group incidence rate reporting in this study. Statistically significant (p<0.05).

The effectiveness of Prevena Therapy in reducing the incidence of SSIs and seroma in all surgical procedures and populations has not been demonstrated. See full indications for use and limitations at hcbgregulatory.3M.com.

Prevena Therapy video resources

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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.

Indication(s) For Use / Intended Use: US FDA Cleared: Only for Use in the United States:

Prevena Dressing used with Prevena Therapy Units: PREVENA™ 125 and PREVENA PLUS™ 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible PREVENA™ dressings for up to seven days, PREVENA™ 125 and PREVENA PLUS™ 125 Therapy Units are intended to aid in reducing the incidence of seroma; and in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

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’2 and the ‘American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines’3 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.

References:

  1. Loubani M, Cooper M, Silverman R, Bongards C, Griffin L. Surgical site infection outcomes of two different closed incision negative pressure therapy systems in cardiac surgery: Systematic review and meta-analysis. Int Wound J. 2024;21(1):e14599. doi:10.1111/iwj.14599
  2. 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
  3. 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