Prevena Incision Management System Wound Care

July 30, 2019 updated by: AdventHealth

Use of Prevena Incision Management System in Wound Morbidity in Complex Ventral Hernia Patients. A Prospective Randomized Control Trial

Comparison of ventral hernia repair using standard wound care versus Prevena.

Study Overview

Status

Terminated

Conditions

Detailed Description

Compare the outcomes for patients who have abdominal reconstruction for ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™ to those patients who have ventral hernia repair to those who have standard wound care.

Study Type

Observational

Enrollment (Actual)

61

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
    • Florida
      • Celebration, Florida, United States, 34747
        • Florida Hospital Celebration Health

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 to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective Ventral hernia repair

Description

Inclusion Criteria:

  1. Age 18 - 89
  2. Open ventral hernia repair with or abdominal wall reconstruction after midline or non-midline defects.
  3. Able to provide informed consent

Exclusion Criteria:

  1. Immunosuppresses patients
  2. Children 0 - 17

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

Cohorts and Interventions

Group / Cohort
Arm 1
Ventral hernia repair using standard wound care.
Arm 2
Ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective for Wound Care Comparison
Time Frame: December 31, 2017
To quantify differences in the routine care of wound morbidity versus the use of Prevena™ by observing the healing process and obtaining quality of life by using the Carolinas Comfort Scale.
December 31, 2017

Collaborators and Investigators

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

Sponsor

AdventHealth

Collaborators

3M

Investigators

  • Principal Investigator: Eduardo Parra Davila, MD, Physician

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 (Actual)

March 29, 2017

Primary Completion (Actual)

October 16, 2018

Study Completion (Actual)

October 16, 2018

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 951279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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