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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by C. R. Bard
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01961687
First received: October 10, 2013
Last updated: October 16, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Ventral Hernia
Incisional Hernia
Device: Phasix Mesh

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Hernia Recurrence Rate [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Hernia recurrence rates will be assessed by physical examination 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. 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 [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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 CDC guidelines for superficial and deep surgical site infections


Secondary Outcome Measures:
  • Pain VAS [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Device related adverse event incidence [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Rate of reoperation due to the index hernia repair [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Carolinas Comfort Scale [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • SF-12 Questionnaire [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Surgical procedure time as measured from incision to closure [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phasix Mesh Device: Phasix Mesh

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

1. 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:

  1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive
  2. 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)
  3. COPD presence on patient self-report
  4. Diabetes mellitus
  5. Immunosuppression
  6. Coronary Artery Disease
  7. Chronic corticosteroid use: greater than 6 months systemic use
  8. Serum albumin less than 3.4 g/dL
  9. Advanced age: 75 years or older
  10. 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:

1. Subject's hernia had recurred more than once (protocol version 1.4)

  1. Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
  2. The subject had peritonitis
  3. The subject was on or suspected to be placed on chemotherapy medications during any part of the study
  4. The subject's Body Mass Index (BMI) was greater than 40 kg/m2
  5. The subject had cirrhosis of the liver and/or ascites
  6. Subject was American Society of Anesthesiology Class 4 or 5
  7. Subject was known to be infected with human immunodeficiency virus (HIV)
  8. Subject had a life expectancy of less than 2 years at the time of enrollment
  9. 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
  10. Subject's hernia repair utilized intraabdominal mesh placement
  11. 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)
  12. Subject had an active or latent systemic infection
  13. Subject required surgical bridge repair as the sole repair
  14. Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding
  15. Subject had enrolled in another clinical study within the last 30 days
  16. Subject was part of the site personnel directly involved with this study
  17. Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961687

Contacts
Contact: Dawn Heimer 401-825-8681 dawn.heimer@crbard.com

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Sarah Lazar    619-543-2379      
Principal Investigator: Sandler, MD         
United States, Florida
Florida Hospital/Celebration Health Recruiting
Celebration, Florida, United States, 34747
Contact: Kimberly Cartwright    407-303-4235      
Principal Investigator: Parra-Davila, MD         
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Marna Burright    847-570-1697      
Principal Investigator: John G Linn, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jean Lonergan    317-688-3690      
Principal Investigator: Selzer, MD         
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40506
Contact: Mandie Zachem    859-323-6346      
Principal Investigator: Roth, MD         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Jennifer Germain    413-794-2672      
Contact: Nicole Corriveau    413-794-2672      
Principal Investigator: Earle, MD         
University of Massachusetts Worcester Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Heather Strom    508-856-1729      
Contact: Oksana Babchenko    508-410-3108      
Principal Investigator: Dunn, MD         
United States, Nebraska
Methodist Health System Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tricia Harrison    402-934-0044      
Principal Investigator: Anthone, MD         
United States, North Carolina
Southeast Area Health and Education Center Recruiting
Wilmington, North Carolina, United States, 28403
Contact: Chiquta Harris    910-667-9253      
Principal Investigator: Hope, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Charlie Borzy    503-494-4949      
Principal Investigator: Martindale, MD         
United States, Tennessee
Univerity of Tennessee Health Science Center Recruiting
Germantown, Tennessee, United States, 38163
Contact: Teresa Riggins    901-866-8530      
Principal Investigator: Voeller, MD         
University of Tennessee Health Sciences Center Recruiting
Knoxville, Tennessee, United States, 37996
Contact: Susan Rawn    865-305-9227      
Principal Investigator: Mancini, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Joan Kaiser    615-343-5821      
Principal Investigator: Poulose, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Contact: Donna Neatrour    804-828-0569      
Principal Investigator: Bittner, MD         
United States, Wisconsin
University of Wisconsin System Recruiting
Madison, Wisconsin, United States, 53792
Contact: Alexandra Procak    608-262-8067      
Principal Investigator: Jacob Greenberg, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Matthew Frelich    414-805-5743      
Principal Investigator: Goldblatt, MD         
Sponsors and Collaborators
C. R. Bard
FGK Clinical Research GmbH
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01961687     History of Changes
Other Study ID Numbers: DVL-HE-011
Study First Received: October 10, 2013
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on October 16, 2014