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

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ClinicalTrials.gov Identifier: NCT02053168
Recruitment Status : Completed
First Posted : February 3, 2014
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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

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

Detailed Description:
Pilot Study of patients across all wound classes for recurrence

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
Study Start Date : February 2014
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

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. Number of Participants With Hernia Recurrence [ Time Frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months ]
    A recurrent hernia was 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 were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.


Secondary Outcome Measures :
  1. Number of Participants With Device Related Adverse Events [ Time Frame: 24 Months ]
    In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.

  2. Carolinas Comfort Scale (CCS) Total Score - Change From Baseline [ Time Frame: Baseline and 24 months postoperative ]
    The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.

  3. Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) [ Time Frame: Baseline and 24 months postoperative ]
    Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It yields 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. The change was calculated as the mean value at 24 months minus the mean value at baseline.

  4. Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) [ Time Frame: Baseline and 24 months postoperative ]
    Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It 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. The change was calculated as the mean value at 24 months minus the mean value at baseline.

  5. Surgical Procedure Time [ Time Frame: Duration of index procedure (mean of 242.5 mins) ]
    Measured from incision to closure (skin to skin).

  6. Length of Hospital Stay [ Time Frame: 10 Months ]
    Measured from end of index procedure to hospital discharge

  7. Number of Study Related Post Operative Surgical Procedures [ Time Frame: 24 Months ]
  8. Number of Study Related Post Operative New Hospital Admissions [ Time Frame: 24 Months ]
  9. Number of Related Post-operative Visits Unrelated to Standard of Care [ Time Frame: 24 Months ]
  10. Incidence of Seroma [ Time Frame: 24 Months ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02053168


Locations
United States, California
Beverly Hills Hernia Center
Beverly Hills, California, United States, 90210
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
United States, Nebraska
Methodist Physicians Clinic
Omaha, Nebraska, United States, 68114
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Yuri Novitsky, MD University Hospitals Cleveland Medical Center
  Study Documents (Full-Text)

Documents provided by C. R. Bard:
Study Protocol  [PDF] August 21, 2014
Statistical Analysis Plan  [PDF] February 2, 2017


Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02053168     History of Changes
Other Study ID Numbers: DVL-HE-015
First Posted: February 3, 2014    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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