Back to resultsEffects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites
Primary Purpose
Obesity, Diabetes, Peripheral Vascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena vac
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring groin incisions
Eligibility Criteria
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
Sites / Locations
- Ohio State Division of Vascular Diseases and Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
negative pressure dressing vs. standard of care
Arm Description
single arm study- randomized Prevena vac or standard of care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01983215
First Posted
September 27, 2013
Last Updated
January 24, 2017
Sponsor
Dr. Jean E. Starr, MD
1. Study Identification
Unique Protocol Identification Number
NCT01983215
Brief Title
Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites
Official Title
EFFECTS OF PREVENA THERAPY ON REDUCTION OF GROIN SURGICAL SITE INFECTIONS IN OBESE PATIENTS UNDERGOING VASCULAR SURGERY
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Jean E. Starr, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Peripheral Vascular Disease
Keywords
groin incisions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
negative pressure dressing vs. standard of care
Arm Type
Experimental
Arm Description
single arm study- randomized Prevena vac or standard of care
Intervention Type
Device
Intervention Name(s)
Prevena vac
Other Intervention Name(s)
randomized 1:1 negative pressure dressing vs. standard of care
Primary Outcome Measure Information:
Title
number of patients with infections
Description
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 Outcome Measure Information:
Title
infection rates
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean E Starr, MD
Organizational Affiliation
The Ohio State Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State Division of Vascular Diseases and Surgery
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites
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