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

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.
 
ClinicalTrials.gov Identifier: NCT01863030
Recruitment Status : Completed
First Posted : May 27, 2013
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
John Roth, University of Kentucky

Brief Summary:

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.

Condition or disease Intervention/treatment
Ventral Hernia Device: Phasix mesh implant

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Actual Study Start Date : May 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Phasix mesh
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Device: Phasix mesh implant



Primary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patents with ventral hernias that meet eligibility criteria.
Criteria

Inclusion Criteria:

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

  1. Subject must be ≥18 years of age.
  2. Subject or subject's legally authorized representative must be willing give written informed consent.
  3. Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
  4. Hernia size greater than 10cm2 and less than 250cm2
  5. 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:

  1. Subject's hernia is multiply recurrent.
  2. CDC wound classification other than clean or clean-contaminated
  3. The use of surgical repair as a bridge.
  4. Patient has a contraindication to placement of mesh.
  5. Concomitant procedures with wound classification other than clean
  6. Subject has peritonitis.
  7. Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
  8. Subject's body mass index (BMI) >55 kg/m2.
  9. Subject has cirrhosis, and/or ascites.
  10. Subject is American Society of Anesthesiology Class 4 or 5.
  11. Subject is known to be infected with human immunodeficiency virus (HIV).
  12. Subject has known allergies to tetracycline or kanamycin.
  13. Subject has a life expectancy of less than 2 years at the time of enrollment.
  14. 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.

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): NCT01863030


Locations
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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
John Roth
Investigators
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Principal Investigator: John S Roth, MD University of Kentucky

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Roth, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01863030    
Other Study ID Numbers: Phasix
First Posted: May 27, 2013    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Roth, University of Kentucky:
Resorbable mesh
Phasix mesh
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes