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

January 24, 2017 updated by: Dr. Jean E. Starr, MD

EFFECTS OF PREVENA THERAPY ON REDUCTION OF GROIN SURGICAL SITE INFECTIONS IN OBESE PATIENTS UNDERGOING VASCULAR SURGERY

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Division of Vascular Diseases and Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: negative pressure dressing vs. standard of care
single arm study- randomized Prevena vac or standard of care
Device: Prevena vac
Other Names:
  • randomized 1:1 negative pressure dressing vs. standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with infections
Time Frame: 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
30 day post surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection rates
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Jean E. Starr, MD

Investigators

  • Principal Investigator: Jean E Starr, MD, The Ohio State Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013H0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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