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

NCT ID: NCT01983215

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Obesity Diabetes Peripheral Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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negative pressure dressing vs. standard of care

single arm study- randomized Prevena vac or standard of care

Group Type EXPERIMENTAL

Prevena vac

Intervention Type DEVICE

Interventions

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Prevena vac

Intervention Type DEVICE

Other Intervention Names

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randomized 1:1 negative pressure dressing vs. standard of care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Jean E. Starr, MD

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jean E. Starr, MD

Vascular surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jean E Starr, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Medical Center

Locations

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Ohio State Division of Vascular Diseases and Surgery

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2013H0045

Identifier Type: -

Identifier Source: org_study_id

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