Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

N/ACompletedNCT02720042

C. R. Bard84 enrolled

Overview

The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia Hernia, Abdominal Hernia, Incisional

Interventions

Phasix™ MeshDEVICE

A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be diagnosed with incisional midline hernia. * Subject has a VHWG Grade 3 hernia (as defined in the protocol). * Size of hernia ≥ 10 cm2. * Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique. Exclusion Criteria: * Subject with \> 4 previous repairs of the hernia under observation. * Body Mass Index (BMI) \> 35 kg/m2. * The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study. * The subject has peritonitis. * Known human immunodeficiency virus (HIV) infection (if documented in the subject's record). * The subject has cirrhosis of the liver and/or ascites. * Subject is American Society of Anesthesiology Class 4 or 5. * Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible. * The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides). * Subject has intact permanent mesh adjacent to the current hernia to be repaired. * Subject's hernia repair requires intraabdominal mesh placement. * Surgical technique requires surgical bridge repair as the sole repair. * 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. * Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding. * Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit. * Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature. * Subject is part of the site personnel directly involved with this study. * Subject has a life expectancy of less than 2 years at the time of enrollment. * Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).

Locations (15)

Wilhelminenspital

Vienna, Austria

Imelda Ziekenhuis

Bonheiden, Belgium

UZ Gent

Ghent, Belgium

Outcomes

Primary Outcomes

Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure

Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>

Time frame: 3 Months

Secondary Outcomes

Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure

Time frame: 24 Months

Number of Participants With a Hernia Recurrence

Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.

Time frame: 24 Months

Number of Participants With One or More Surgical Site Infection

Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.

Data from ClinicalTrials.gov

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