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Protecting incisions beyond the OR

Support your patients’ recovery with 3M™ Prevena™ Therapy incision management, to help protect and bolster the incision site, optimize the healing environment of the closed incision, and reduce surgical site complications.

Prevena Restor™ BellaForm™ Incision Management System Patient can manage therapy at home

Proactively manage postoperative recovery

In today's healthcare landscape, where complex surgeries and patient comorbidities are prevalent, effective postoperative care is crucial to reduce extended hospital stays, readmissions and to improve overall patient outcomes. The Prevena Incision Management System is designed to proactively manage the environment of closed surgical incisions, such as superficial surgical site infections in Class I and Class II wounds* in patients at high risk for postoperative infections and incidence of seroma by maintaining a sealed environment with negative pressure therapy. This closed-incision negative pressure therapy (ciNPT) system provides:

  • Protection: Prevena dressings create a barrier against external contamination 
  • Negative pressure: Delivers continuous -125mmHg negative pressure therapy for up to 7 or 14 days with dressing changes required at 7 days 
  • Incision support: Aids in keeping incision edges together, reducing lateral tension 
  • Fluid management: Removes fluids and infectious materials, helping to reduce edema 
  • Postoperative care: When used with legally marketed Prevena dressings for up to 7 days 3M™ Prevena™ 125 and 3M™ Prevena™ Plus 125 Therapy Units can help reduce the incidence of seromas and superficial surgical site infections (SSIs) in high-risk patients with Class I and II wounds

*The effectiveness of Prevena Therapy in reducing the incidence of SSIs and seroma in all surgical procedures and populations has not been demonstrated. Please see the full indications for use and limitations below.

The Prevena Restor Incision Management System advances original Prevena Therapy expanding NPWT coverage over closed incisions and the surrounding soft tissue to help postoperative recovery. The system introduces new features to improve patient care including:  

  • Expanded coverage: Larger dressing coverage area for the incision and adjacent soft tissue, protecting and bolstering the surgical site and optimizing the healing environment  
  • Extended Therapy: The 3M™ Prevena™ Plus Therapy Unit provides 14 days of continuous NPWT; dressing changes required at 7 days  
  • Precision design: The dressing adapts to the patient’s body, allowing movement  
  • Versatile application: Intuitive, easy-to-use peel-and-place and flexible, user-customizable dressings available

Prevena Incision Management System: Mechanism of Action

Evidence-based proactive risk management

To empower you to elevate care standards for ciNPT, Proactive Risk Management (PRM) with Prevena Therapy provides a systematic, evidence-backed approach. This clear, actionable model, supported by level 1, 2 and 3 clinical evidence, aids in assessing both procedural and patient risks, guiding the identification of those who would benefit most from Prevena Therapy and helping to reduce the costly complications of SSIs. 

SSIs account for 22 – 36% of all healthcare-associated infections1,2 and are a costly complication resulting in:

6X increased likelihood of 30-day readmission3

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$38,656 in additional costs4

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9.58 days longer stays in hospital4

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2.2X longer ICU stays3

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To help reduce the risk of postoperative complications, Prevena Therapy has demonstrated significant improvement in key outcomes across multiple specialities5, including:

reduction in surgical site complications (SSCs)

46 studies; p<.001

Icon illustration 46%

reduction in surgical site infections (SSIs)

65 studies; p<.001

Icon illustration 47%

reduction in reoperations

40 studies; p<.001

Icon illustration 36%

reduction in readmissions

24 studies; p=.039

Icon illustration 23%

**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.

Versatile options for your needs

Explore the wide selection of Prevena devices, dressings and kits – uniquely designed to meet the various needs of healthcare providers, surgical procedures and anatomical locations.

Prevena Therapy’s eco-friendly disposal program

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We appreciate your commitment to sustainability. Solventum's collaboration with Sharps® Compliance, Inc. ensures the eco-friendly disposal of your Prevena Therapy single-use negative pressure therapy units, free of charge.

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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’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.

References :

  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