Ventral Hernia
Conditions
Keywords
Resorbable mesh, Phasix mesh
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.
Interventions
DEVICEPhasix mesh implant
Sponsors
John Roth
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning Quality of Life Outcome | 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. |
| Role Physical Quality of Life Outcome | 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. |
| Bodily Pain Quality of Life Outcome | 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. |
| Role Emotional Quality of Life Outcome | 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. |
| General Health Quality of Life Outcome | 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. |
| Physical Component Summery | 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. |
| Vitality Quality of Life Outcome | 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. |
| Social Functioning Quality of Life Outcome | 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. |
| Mental Health Quality of Life Outcome | 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. |
| Abdominal Wall Mobility | 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. |
| Abdominal Wall Function | 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 |
| Mental Component Summery | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects with a diagnosis of a ventral or incisional hernia requiring surgical repair to close the defect were recruited. First subject enrolled June 2013. The last subject was enrolled August 2014.
Participants by arm
| Arm | Count |
|---|---|
| Phasix Mesh Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Phasix Mesh |
|---|---|
| Age, Continuous | 52 years |
| BMI | 33 kg/m^2 |
| CDC Wound Classification Grade 1 | 30 Participants |
| CDC Wound Classification Grade 2 | 1 Participants |
| Component Separation Technique Endo CST | 30 participants |
| Component Separation Technique Open CST | 31 participants |
| Component Separation Technique Posterior CST | 18 participants |
| Component Separation Technique Rives Stoppa | 11 participants |
| Employment Activity Employment activity not answered | 1 Participants |
| Employment Activity Manual Labor | 6 Participants |
| Employment Activity not employed | 19 Participants |
| Employment Activity Sedentary | 5 Participants |
| Employment Status Disabled | 8 Participants |
| Employment Status Employed | 12 Participants |
| Employment Status Unemployed/retired | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Graft Size | 592 cm2 |
| Hernia Defect Size | 105 cm2 |
| Number of Grafts used 1 graft | 30 Participants |
| Number of Grafts used 2 grafts | 1 Participants |
| Number of participants where PDS sutures were used during hernia repair procedure | 31 Participants |
| Number of participants who had a concurrent procedure | 3 Participants |
| Number of participants who had drains placed during hernia repair procedure 1 drain | 10 participants |
| Number of participants who had drains placed during hernia repair procedure 2 drains | 19 participants |
| Number of participants who had drains placed during hernia repair procedure 3 drains | 2 participants |
| Number of Participants with Anterior Rectus Sheath Approximation | 31 Participants |
| Number of Participants with History of Tobacco Use | 7 Participants |
| Number of Participants with Posterior Rectus Sheath Approximation | 31 Participants |
| Number of Participants with Retro Rectus Mesh Placement | 31 Participants |
| Operation Duration | 140 Minutes |
| Past Medical History Cancer | 5 Participants |
| Past Medical History Chronic Heart Failure/ Coronary Artery Disease | 5 Participants |
| Past Medical History Chronic Pain | 10 Participants |
| Past Medical History COPD | 9 Participants |
| Past Medical History Diabetes | 8 Participants |
| Past Medical History Genitourinary disease | 5 Participants |
| Past Medical History GERD | 12 Participants |
| Past Medical History Mental Health Disease | 4 Participants |
| Past Medical History Peripheral Vascular Disease | 1 Participants |
| Prior Abdominal Surgery | 30 Participants |
| Prior Hernia Repair | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 31 Participants |
| Removal of Previous mesh during hernia repair procedure | 4 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 6 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
Time frame: up to 24 months post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix Mesh | Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh | 0 Participants |
Other Pre-specified
Abdominal Wall Function
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
Time frame: up to 12 months post surger
Other Pre-specified
Abdominal Wall Mobility
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.
Time frame: 12 Months
Other Pre-specified
Bodily Pain Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Bodily Pain Quality of Life Outcome | Baseline/ pre operation | 38.5 units on a scale | Standard Deviation 12.7 |
| Phasix Mesh | Bodily Pain Quality of Life Outcome | 12 months post operation | 45.9 units on a scale | Standard Deviation 11.1 |
| Phasix Mesh | Bodily Pain Quality of Life Outcome | 24 months post operation | 44.5 units on a scale | Standard Deviation 13.1 |
Other Pre-specified
General Health Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | General Health Quality of Life Outcome | Baseline/ pre operation | 43.3 units on a scale | Standard Deviation 91 |
| Phasix Mesh | General Health Quality of Life Outcome | 12 months post operation | 50.7 units on a scale | Standard Deviation 10.4 |
| Phasix Mesh | General Health Quality of Life Outcome | 24 months post operation | 43.9 units on a scale | Standard Deviation 12.6 |
Other Pre-specified
Mental Component Summery
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Mental Component Summery | Baseline/ pre operation | 46.5 units on a scale | Standard Deviation 11.7 |
| Phasix Mesh | Mental Component Summery | 12 months post operation | 48.3 units on a scale | Standard Deviation 9.8 |
| Phasix Mesh | Mental Component Summery | 24 months post operation | 47.9 units on a scale | Standard Deviation 10.9 |
Other Pre-specified
Mental Health Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Mental Health Quality of Life Outcome | Baseline/ pre operation | 45.3 units on a scale | Standard Deviation 13.3 |
| Phasix Mesh | Mental Health Quality of Life Outcome | 12 months post operation | 50.3 units on a scale | Standard Deviation 8.5 |
| Phasix Mesh | Mental Health Quality of Life Outcome | 24 months post operation | 47.0 units on a scale | Standard Deviation 14.2 |
Post Hoc
Pain Assessment
Pain rating on a numeric rating scale (0=no pain, 10=extreme pain)
Time frame: up to 24 months post surgery
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phasix Mesh | Pain Assessment | 2 weeks post operation | 4.0 units on a scale |
| Phasix Mesh | Pain Assessment | 3 months post operation | 1.0 units on a scale |
| Phasix Mesh | Pain Assessment | 6 months post operation | 1.0 units on a scale |
| Phasix Mesh | Pain Assessment | 12 months post operation | 1.0 units on a scale |
| Phasix Mesh | Pain Assessment | 24 months post operation | 2.5 units on a scale |
Other Pre-specified
Physical Component Summery
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Physical Component Summery | Baseline/ pre operation | 38.9 units on a scale | Standard Deviation 10 |
| Phasix Mesh | Physical Component Summery | 12 months post operation | 47.2 units on a scale | Standard Deviation 9.7 |
| Phasix Mesh | Physical Component Summery | 24 months post operation | 43.9 units on a scale | Standard Deviation 9.4 |
Other Pre-specified
Physical Functioning Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Physical Functioning Quality of Life Outcome | 12 months post operation | 46.4 units on a scale | Standard Deviation 11.6 |
| Phasix Mesh | Physical Functioning Quality of Life Outcome | Baseline/ pre operation | 39.8 units on a scale | Standard Deviation 12.1 |
| Phasix Mesh | Physical Functioning Quality of Life Outcome | 24 months post operation | 44.5 units on a scale | Standard Deviation 12.2 |
Other Pre-specified
Role Emotional Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Role Emotional Quality of Life Outcome | Baseline/ pre operation | 42.5 units on a scale | Standard Deviation 12.9 |
| Phasix Mesh | Role Emotional Quality of Life Outcome | 12 months post operation | 43.5 units on a scale | Standard Deviation 13 |
| Phasix Mesh | Role Emotional Quality of Life Outcome | 24 months post operation | 44.8 units on a scale | Standard Deviation 12 |
Other Pre-specified
Role Physical Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Role Physical Quality of Life Outcome | Baseline/ pre operation | 39.0 units on a scale | Standard Deviation 11.7 |
| Phasix Mesh | Role Physical Quality of Life Outcome | 12 months post operation | 46.1 units on a scale | Standard Deviation 44.2 |
| Phasix Mesh | Role Physical Quality of Life Outcome | 24 months post operation | 44.2 units on a scale | Standard Deviation 11.1 |
Other Pre-specified
Social Functioning Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Social Functioning Quality of Life Outcome | Baseline/ pre operation | 43.4 units on a scale | Standard Deviation 12.1 |
| Phasix Mesh | Social Functioning Quality of Life Outcome | 12 months post operation | 47.0 units on a scale | Standard Deviation 11.3 |
| Phasix Mesh | Social Functioning Quality of Life Outcome | 24 months post operation | 48.6 units on a scale | Standard Deviation 9.8 |
Post Hoc
Tenderness Assessment
Tenderness measure on a numeric rating scale (0=no tenderness, 10= extreme tenderness)
Time frame: 24 months
Population: 31 patients were implanted. patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phasix Mesh | Tenderness Assessment | 2 weeks post operation | 3.0 units on a scale |
| Phasix Mesh | Tenderness Assessment | 3 months post operation | 1.0 units on a scale |
| Phasix Mesh | Tenderness Assessment | 6 months post operation | 1.0 units on a scale |
| Phasix Mesh | Tenderness Assessment | 12 months post operation | 1.0 units on a scale |
| Phasix Mesh | Tenderness Assessment | 24 months post operation | 1.0 units on a scale |
Other Pre-specified
Vitality Quality of Life Outcome
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.
Time frame: baseline, 12 months, 24 months
Population: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Vitality Quality of Life Outcome | Baseline/ pre operation | 45.3 units on a scale | Standard Deviation 12.1 |
| Phasix Mesh | Vitality Quality of Life Outcome | 12 months post operation | 50.2 units on a scale | Standard Deviation 9.8 |
| Phasix Mesh | Vitality Quality of Life Outcome | 24 months post operation | 47.1 units on a scale | Standard Deviation 10 |