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Completed

NCT Number: NCT02053168

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

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

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beverly Hills Hernia Center, Beverly Hills, California, United States

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About this study

Pilot Study of patients across all wound classes for recurrence

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resorbable Mesh

Device

Phasix Mesh

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2014
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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