A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-02-23

Brief Summary

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Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

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Detailed Description

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Pilot Study of patients across all wound classes for recurrence

Conditions

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Ventral Hernia Incisional Hernia

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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Resorbable Mesh

Phasix Mesh

Group Type OTHER

Resorbable Mesh

Intervention Type DEVICE

Phasix Mesh

Interventions

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Resorbable Mesh

Phasix Mesh

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject or subject's legally authorized representative must be willing to give written informed consent
* Subject must be diagnosed with ventral or incisional hernia
* Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria

* Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
* Subject's hernia has recurred four or more times.
* Subject's body mass index (BMI) \>40 kg/m2.
* Subject has peritonitis.
* Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
* Chronic steroid use or immunosuppression drugs (\> 6 months).
* Subject has cirrhosis, and/or ascites.
* Subject is American Society of Anesthesiology Class 4 or 5.
* Subject is pregnant or planning to become pregnant during the course of the study.
* Subject is known to be infected with human immunodeficiency virus (HIV).
* Subject has a life expectancy of less than 2 years at the time of enrollment.
* Subject has been treated with an investigational product in the past 30 days.
* Subject is part of the site personnel directly involved with this study
* Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
* Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No