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PREVENA™ Therapy Expanded FDA Indication


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'1 and the ‘American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines' 2for best practices in preventing surgical site infection.

 

CLINICAL EVIDENCE SUPPORTING THE NEW INDICATION

A systematic literature review and associated meta-analysis were used to support the safety and effectiveness of PREVENA™ Therapy over closed incisions in reducing the incidence of surgical site infections (SSIs) and seromas versus conventional wound dressings.
 
  • Out of 426 studies in the initial search, ultimately, sixteen (16) prospective studies were included in this meta-analysis for SSI characterization
  • A total of up to 6,187 evaluable patients were included in this meta-analysis for SSI with 1,264 in the PREVENA™ Therapy (treatment) group and 4,923 in the conventional wound dressing (control) group
  • 9 randomized controlled trials (RCTs) were included in a subgroup analysis for SSI in high risk patients
 
PREVENA™ Therapy demonstrated the greatest benefit in reducing SSIs in high risk patients
 
 
Forest Plot of Meta-Analysis on Surgical Site Infection

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NOTE: Specific indications, contraindications, warnings, precautions, and safety information exist for PREVENA™ Therapy. Please consult the applicable PREVENA™ System Clinician Guide instructions for use prior to application. This material is intended for healthcare professionals.
 
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REFERENCES
  1. 1. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017;152(8):784–791. doi:10.1001/jamasurg.2017.0904
    2. Ban, K. A., Minei, J. P., Laronga, C., Harbrecht, B. G., Jensen, E. H., Fry, D. E., . . . 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. doi:10.1016/j.jamcoll-surg.2016.10.029
 
 

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