Effects of Prevena Therapy on Obese and or Diabetic Patie... | NCT01983215

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

NCT01983215

Sponsor

Dr. Jean E. Starr, MD

Status

Unknown status

Last Update Posted

Jan 25, 2017Estimated

Enrollment

276Actual

Phase

Not Applicable

Conditions

Obesity
Diabetes
Peripheral Vascular Disease

Interventions

Prevena vac

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Sep 27, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
negative pressure dressing vs. standard of care	Experimental	single arm study- randomized Prevena vac or standard of care	Device: Prevena vac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prevena vac	Device		negative pressure dressing vs. standard of care	randomized 1:1 negative pressure dressing vs. standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean E Starr, MD	The Ohio State Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio State Division of Vascular Diseases and Surgery		Columbus	Ohio	43210	United States

Type	Date	Date Unknown
Release	Feb 8, 2023
Reset	Mar 6, 2023
Release	Mar 9, 2023
Reset	Apr 5, 2023
Release	Apr 7, 2025
Reset	Apr 23, 2025
Release	Apr 30, 2025
Reset	May 16, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 8, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 8, 2023			Mar 6, 2023
Mar 9, 2023

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003920	Diabetes Mellitus
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011897	Random Allocation

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided