heart surgery sternotomy
Conditions
Interventions
Treatment with Prevena IMS compared to conventional wound treatment.
Sponsors
KCI-Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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. *A total score of at least 8 points for the following risk factors: >MAJOR risk factors receiving 8 points *BMI * 40 kg/m2 * >MAJOR risk factors receiving 4 points each: *BMI of INTERMEDIATE risk factors receiving 2 points each: *Planned bilateral mammary artery *Diabetes Mellitus (only Type I or Type II receiving oral hypoglycemic medication)* *Chronic lung disease GOLD *2 *Active smoker *On long-term immunosuppressive medication (including but not restricted to cyclophosphamide, methotrexate, azathioprine, cyclosporine, tacrolimus or mycophenalate mofetil; or on a stable maintenance dose of prednisolone for 4 weeks or more; or will receive chronic immunosuppressant therapy during the study period (equivalent to a daily dose of * 10 mg Prednisone) *Chronic kidney disease (defined according to the National Kidney Foundation Kidney Disease Improving Global Outcomes (KDIGO) guidelines as a GFR MINOR risk factors receiving 1 point each: *Cardiac reoperation after history of median sternotomy *Peripheral vascular disease *Left ventrical ejection fraction 75 years old *Acute myocardial infarction within 90 days before surgery *Hospitalized at least 7 days before surgery;* mutually exclusive, highest score should be used ** mutually exclusive, highest score should be used;* Is capable of providing informed consent, which must be obtained prior to any study-related procedures * Are willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
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) * Has current nasal swabs 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 allowed) * Any other therapies or procedures that, in the opinion of the treating physician, would affect or influence postoperative wound stability or healing * Is simultaneously participating in another interventional trial * Requires use of liquid skin adhesives or glues during skin closure * Is known to be serology positive for hepatitis B, hepatitis C, and HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection (SSI) within 30 days postoperatively, defined as superficial, deep, and organ space infections as per CDC guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Sternal wound dehiscence without the presence of infection, defined as any partial or complete separation of the skin, subcutaneous layer and or sternal edges, with or without psuedoarthosis, and/or serosanguinous discharge from the wound. * Overall mortality within 3 months | — |
Countries
Netherlands
Outcome results
None listed