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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01983215
• Other study ID #: 2013H0045
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 27, 2013
• Last updated: January 24, 2017
• Start date: April 2013
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 276
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Prevena vac

Locations

Country	Name	City	State
United States	Ohio State Division of Vascular Diseases and Surgery	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Jean E. Starr, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 day post surgical procedure
Secondary	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	1 year