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Completed

NCT Number: NCT01863030

A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:

1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perioperative, short-term and long-term procedural and/or device related complications. 3. Abdominal Wall Function and mobility.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The subject must meet all of the relevant criteria listed below to be enrolled in the study:

  • Subject must be ≥18 years of age.
  • Subject or subject's legally authorized representative must be willing give written informed consent.
  • Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
  • Hernia size greater than 10cm2 and less than 250cm2
  • Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion criteria

The subject must be excluded from study enrollment if any of the following criteria are met:

  • Subject's hernia is multiply recurrent.
  • CDC wound classification other than clean or clean-contaminated
  • The use of surgical repair as a bridge.
  • Patient has a contraindication to placement of mesh.
  • Concomitant procedures with wound classification other than clean
  • Subject has peritonitis.
  • Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
  • Subject's body mass index (BMI) >55 kg/m2.
  • Subject has cirrhosis, and/or ascites.
  • Subject is American Society of Anesthesiology Class 4 or 5.
  • Subject is known to be infected with human immunodeficiency virus (HIV).
  • Subject has known allergies to tetracycline or kanamycin.
  • Subject has a life expectancy of less than 2 years at the time of enrollment.
  • Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.

Treatment and study plan

Phasix mesh implant

Device

Primary outcomes

  1. Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh

    Time frame: up to 24 months post surgery

    Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.

Other outcomes

  1. Physical Component Summery

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12. Physical component summery. Assessment of physical limitations such as bathing, dressing, or physical activities. Scales range from 0-100. Low scores indicate someone with many limitations, while high scores indicate someone with no or few limitations.

  2. Role Emotional Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Role emotional subdomain. This assesses if the patient experiences problems with work or other daily activities as a result of their emotional health. Scales range from 0-100. Low scores indicate the patient experiences many problems at work or with other daily activities as a result of poor emotional health. High scores indicate no problems with work or daily activities as a result of emotional health.

  3. Physical Functioning Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Physical Functioning subdomain. Assesses ability to perform physical activities, including bathing and dressing one's self. Scales range from 0-100. Low scores indicate many limitations with physical activities. High scores indicate no problems with physical activities.

  4. Role Physical Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Role physical subdomain. Assesses ability to perform physical activity such as bathing and dressing one's self. Scales range from 0-100. Low scores indicate problems with physical activities. High scores indicate no problems performing physical activities.

  5. Bodily Pain Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Bodily Pain subdomain. Assesses level of bodily pain. scales range from 0-100. low scores indicate a severe level of pain that is limiting. High scores indicate a low level of pain or no pain-related limitations.

  6. General Health Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 General Health Subdomain. Assesses level of general health related to . Scales 0-100. low scores indicate poor general health, and high scores indicate good general health.

  7. Mental Component Summery

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Mental Component Summery. Assesses level of mental health. Scales range from 0-100. Low scores indicate nervousness and depression. High scores indicate feeling peaceful, happy, and calm.

  8. Vitality Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Vitality subdomain. Assesses level of energy. Scales range from 0-100. Low scores indicate low levels of energy, while high scores indicate high levels of energy.

  9. Social Functioning Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Social Functioning subdomain. Assesses ability to participate in normal social activities without difficulties due to physical or emotional health problems. Scores are normalized to 0-100, with 50 being the national normalized mean. Lower scores indicate many difficulties with normal social activities due to physical or emotional health problems. Higher scores indicate little or no difficulties with normal social activities due to physical or emotional health problems.

  10. Mental Health Quality of Life Outcome

    Time frame: baseline, 12 months, 24 months

    Quality of life survey- Short Form 12 Mental Health subdomain. assesses level of mental health. Scale ranges from 0-100. Low scores indicate depression and nervousness. High scores indicate feeling peaceful, happy, and calm.

  11. Abdominal Wall Mobility

    Time frame: 12 Months

    Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively.

  12. Abdominal Wall Function

    Time frame: up to 12 months post surger

    Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively

Sponsors and collaborators

Lead sponsor

John Roth

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 27, 2013
Registry last updated
Jan 21, 2020

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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