Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites

N/AUnknownNCT01983215

Dr. Jean E. Starr, MD276 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

276

Conditions

Obesity Diabetes Peripheral Vascular Disease

Interventions

Prevena vacDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ohio State Division of Vascular Diseases and Surgery

Columbus, Ohio, United States

Outcomes

Primary Outcomes

number of patients with infections

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

Time frame: 30 day post surgical procedure

Secondary Outcomes

infection rates

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

Time frame: 1 year

Data from ClinicalTrials.gov

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