Prevena Incision Management System Wound Care

NCT ID: NCT02953769

Last Updated: 2019-08-01

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

TERMINATED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-29

Study Completion Date

2018-10-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventral Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1

Ventral hernia repair using standard wound care.

No interventions assigned to this group

Arm 2

Ventral hernia repair, regarding wound morbidity, post-operative pain and patient comfort to ambulation, with the use of Prevena™

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KCI USA, Inc

INDUSTRY

Sponsor Role collaborator

AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduardo Parra Davila, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

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Florida Hospital Celebration Health

Celebration, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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951279

Identifier Type: -

Identifier Source: org_study_id

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