The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The study is conducted in The Netherlands, Germany and Austria.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is male or female and 18 years of age or older
* Is scheduled for elective cardiac surgery for which a median sternotomy is needed (including coronary artery bypass grafting (CABG), valvular repair or replacement with or without CABG). Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
* Is capable of providing informed consent, which must be obtained prior to any study-related procedures
* Is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
* Is pregnant
* The use of Prevena post surgery is contra indicated per investigator's discretion
* Has a systemic infection at the time of surgery: systemic infection is diagnosed on the basis of clinical signs of sepsis with or without a positive culture of an organism from the bloodstream
* Has a remote body site infection at the time of surgery (including dental, urinary or skin soft tissue infections)
* Is known to have a current nasal swab positive for methicillin-resistant staphylococcus aureus (MRSA)
* Has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
* Has a requirement for competing wound therapy and procedures.
* Any concomitant therapies (including other NPWT treatment) or procedures deviating from the clinical standard incision treatment or with investigational device at the location of the sternotomy (e.g. use of NPWT at other location of the body is al…
What they're measuring
1
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.