A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Not Applicable

Completed

Conditions: Incisional Hernia
Ventral Hernia

Interventions: Device: Resorbable Mesh

Registration Number: NCT01961687

Lead Sponsor: C. R. Bard

Brief Summary: Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

Detailed Description: The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

Inclusion Criteria

Subjects must have met all of the criteria listed below to be enrolled in the study:

Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions:
Body Mass Index (BMI) between 30-40 kg/m2, inclusive
Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)
COPD presence on patient self-report
Diabetes mellitus
Immunosuppression
Coronary Artery Disease
Chronic corticosteroid use: greater than 6 months systemic use
Serum albumin less than 3.4 g/dL
Advanced age: 75 years or older
Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

Exclusion Criteria

Subjects were excluded from study enrollment if any of the following criteria were met:

Subject's hernia had recurred more than once (protocol version 1.4)
Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
The subject had peritonitis
The subject was on or suspected to be placed on chemotherapy medications during any part of the study
The subject's Body Mass Index (BMI) was greater than 40 kg/m2
The subject had cirrhosis of the liver and/or ascites
Subject was American Society of Anesthesiology Class 4 or 5
Subject was known to be infected with human immunodeficiency virus (HIV)
Subject had a life expectancy of less than 2 years at the time of enrollment
Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements
Subject's hernia repair utilized intraabdominal mesh placement
Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol)
Subject had an active or latent systemic infection
Subject required surgical bridge repair as the sole repair
Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding
Subject had enrolled in another clinical study within the last 30 days
Subject was part of the site personnel directly involved with this study
Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resorbable Mesh	Resorbable Mesh	Phasix Mesh

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence Rate	60 Months	Hernia recurrence rates will be assessed by physical examination at each study visit through 60 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. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Surgical Site Infections	60 Months	Infections at the surgical site will be assessed by physical examination at each study visit through 60 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 CDC guidelines for superficial and deep surgical site infections

Secondary Outcome Measures

Name	Time	Method
Rate of Re-operation Due to the Index Hernia Repair	60 Months	Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.
Length of Hospital Stay	35 days	Time in days from hospital admission to discharge
Device Related Adverse Events	60 Months	Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events.
Surgical Procedure Time as Measured From Incision to Closure	1 day	Surgical procedure time as measured from incision to closure (skin to skin)
Pain Visual Analog Scale	60 Months	Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.
Carolinas Comfort Scale® (CCS)	60 Months	Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
SF-12 Questionnaire	60 Months	The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Trial Locations

Locations (16): University of Kentucky Medical Center
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Lexington, Kentucky, United States
Baystate Medical Center
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Springfield, Massachusetts, United States
University of Massachusetts Worcester
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Worcester, Massachusetts, United States
Southeast Area Health and Education Center
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Wilmington, North Carolina, United States
Univerity of Tennessee Health Science Center
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Germantown, Tennessee, United States
University of Tennessee Health Sciences Center
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Knoxville, Tennessee, United States
NorthShore University HealthSystem
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Evanston, Illinois, United States
Florida Hospital/Celebration Health
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Celebration, Florida, United States
University of Wisconsin System
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Madison, Wisconsin, United States
Indiana University
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Indianapolis, Indiana, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
Methodist Health System
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Omaha, Nebraska, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Virginia Commonwealth University
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Richmond, Virginia, United States
University of California, San Diego
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San Diego, California, United States
Oregon Health and Science University
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Portland, Oregon, United States