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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01961687
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : April 18, 2018
FGK Clinical Research GmbH
Information provided by (Responsible Party):
C. R. Bard

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

Condition or disease Intervention/treatment Phase
Ventral Hernia Incisional Hernia Device: Resorbable Mesh Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Study Start Date : September 2013
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Resorbable Mesh
Phasix Mesh
Device: Resorbable Mesh
Phasix Mesh

Primary Outcome Measures :
  1. Hernia Recurrence Rate [ Time Frame: 60 Months ]
    Hernia recurrence rates will be assessed by physical examination at each study visit through 36 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.

  2. Surgical Site Infections [ Time Frame: 60 Months ]
    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 :
  1. Pain VAS [ Time Frame: 60 Months ]
  2. Device related adverse event incidence [ Time Frame: 60 Months ]
  3. Rate of reoperation due to the index hernia repair [ Time Frame: 60 Months ]
  4. Carolinas Comfort Scale [ Time Frame: 60 Months ]
  5. SF-12 Questionnaire [ Time Frame: 60 Months ]
  6. Surgical procedure time as measured from incision to closure [ Time Frame: Up to 450 minutes ]
  7. Length of hospital stay [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01961687

United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Florida
Florida Hospital/Celebration Health
Celebration, Florida, United States, 34747
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40506
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Worcester
Worcester, Massachusetts, United States, 01655
United States, Nebraska
Methodist Health System
Omaha, Nebraska, United States, 68114
United States, North Carolina
Southeast Area Health and Education Center
Wilmington, North Carolina, United States, 28403
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Univerity of Tennessee Health Science Center
Germantown, Tennessee, United States, 38163
University of Tennessee Health Sciences Center
Knoxville, Tennessee, United States, 37996
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
United States, Wisconsin
University of Wisconsin System
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
C. R. Bard
FGK Clinical Research GmbH
Principal Investigator: Scott Roth, MD University of Kentucky

Responsible Party: C. R. Bard Identifier: NCT01961687     History of Changes
Other Study ID Numbers: DVL-HE-011
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes