Diabetes, Obesity, Peripheral Vascular Disease
Conditions
Keywords
groin incisions
Brief summary
The purpose of the study is to determine the effects of Prevena therapy on decreasing groin surgical site infections in patients who are obese and /or diabetic having vascular surgery.
Detailed description
Patients who are obese and/or diabetic may have poor surgical healing and infection rates higher. The PREVENA therapy will be used to evaluate possible reduction of infection rates in this patient population
Interventions
DEVICEPrevena vac
Sponsors
Dr. Jean E. Starr, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* subjects over 18 years old * obese (BMI \> 30) and or diabetic
Exclusion criteria
* current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with infections | 30 day post surgical procedure | reduction of 30 day surgical site infection by evaluating infection rates in obese, diabetic patients who were randomized to Prevena Vac vs. standard of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| infection rates | 1 year | reduction of 1 year graft infection in prosthetic grafts and reduction of secondary hospitalizations for infection.Patients will be followed through 1 year to measure results of infection rates and secondary hospitalization related to infection |
Countries
United States
Outcome results
None listed