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Status unknownNCT01983215Updated Jan 25, 2017

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

An interventional study of Prevena vac in Obesity, Diabetes and Peripheral Vascular Disease, sponsored by Dr. Jean E. Starr, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Dr. Jean E. Starr, MD · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
276
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Obesity
  • Diabetes
  • Peripheral Vascular Disease

Keywords

  • groin incisions
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 276 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

This is the only study on the registry with Dr. Jean E. Starr, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subjects over 18 years old
  • obese (BMI > 30) and or diabetic

Exclusion criteria

Exclusion Criteria:

  • current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
276 participants (actual)

Study arms

  • Experimental
    negative pressure dressing vs. standard of care

    single arm study- randomized Prevena vac or standard of care

    Device: Prevena vac

Interventions

  • DevicePrevena vac

    Also known as: randomized 1:1 negative pressure dressing vs. standard of care

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What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Ohio State Division of Vascular Diseases and Surgery
    Columbus, Ohio 43210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01983215
Lead sponsor
Dr. Jean E. Starr, MD
Responsible party
Dr. Jean E. Starr, MD (Vascular surgeon, Ohio State University) — Sponsor-investigator
First posted
Nov 13, 2013
Start date
Apr 2013
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 25, 2017

Study contacts

Jean E Starr, MD
principal investigator · The Ohio State Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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