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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phasix mesh | Mesh being used for approved use. Mesh for ventral and incisional hernias. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phasix mesh implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24 months post surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 12 months, 24 months |
Inclusion Criteria:
The subject must meet all of the relevant criteria listed below to be enrolled in the study:
Exclusion Criteria:
The subject must be excluded from study enrollment if any of the following criteria are met:
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Patents with ventral hernias that meet eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| John S Roth, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28916979 | Derived | Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phasix Mesh | Phasix mesh implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Follow up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phasix Mesh | Mesh being used for approved use. Mesh for ventral and incisional hernias. Phasix mesh implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 24 months post surgery |
|
|
3 years, 3 months, 9 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phasix Mesh | Mesh being used for approved use. Mesh for ventral and incisional hernias. Phasix mesh implant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Roth M.D. | University of Kentucky Medical Center | 859-323-6346 | 240 | sroth@uky.edu |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | baseline, 12 months, 24 months |
| 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. | 12 Months |
| 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 | up to 12 months post surger |
| 6 Months |
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| 12 Months |
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| 24 Months |
|
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Employment Status | Count of Participants | Participants |
|
| Employment Activity | Count of Participants | Participants |
|
| Past Medical History | Count of Participants | Participants |
|
| Number of Participants with History of Tobacco Use | Count of Participants | Participants |
|
| Prior Abdominal Surgery | Count of Participants | Participants |
|
| Prior Hernia Repair | Count of Participants | Participants |
|
| Operation Duration | Median | Inter-Quartile Range | Minutes |
|
| CDC Wound Classification | CDC wound class Class 1: An uninfected operative wound in which no inflammation is encountered. Class 2: An operative wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Class 3: Open, fresh, accidental wounds. Operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract. Incisions with acute, nonpurulent inflammation. Class 4: Old traumatic wounds with retained devitalized tissue. Those that involve existing clinical infection or perforated viscera. | Count of Participants | Participants |
|
| Removal of Previous mesh during hernia repair procedure | Removal of previous mesh that was in place prior to enrollment. | Count of Participants | Participants |
|
| Hernia Defect Size | Size of the hernia defect before repair. Measured during hernia repair procedure. | Median | Inter-Quartile Range | cm2 |
|
| Graft Size | Median | Inter-Quartile Range | cm2 |
|
| Number of Grafts used | Count of Participants | Participants |
|
| Number of Participants with Retro Rectus Mesh Placement | Number of participants in which the mesh is placed above the posteriorrectus sheath and below the muscle. | Count of Participants | Participants |
|
| Component Separation Technique | Number | participants |
|
| Number of Participants with Posterior Rectus Sheath Approximation | Number of participants in which the two sides of the posterior sheaths are sewn together in entirety. | Count of Participants | Participants |
|
| Number of Participants with Anterior Rectus Sheath Approximation | Number of participants in which both the right and left side of the sheath are sewn together with no gaps. | Count of Participants | Participants |
|
| Number of participants where PDS sutures were used during hernia repair procedure | Count of Participants | Participants |
|
| Number of participants who had drains placed during hernia repair procedure | Number | participants |
|
| Number of participants who had a concurrent procedure | Number of participants who had a concurrent procedure at the same time as the index hernia repair procedure. | Count of Participants | Participants |
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months, 24 months |
|
|
|
| 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. | Not Posted | 12 Months | 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 | Not Posted | up to 12 months post surger | Participants |
| Post-Hoc | Pain Assessment | Pain rating on a numeric rating scale (0=no pain, 10=extreme pain) | 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. | Posted | Median | Inter-Quartile Range | units on a scale | up to 24 months post surgery |
|
|
|
| Post-Hoc | Tenderness Assessment | Tenderness measure on a numeric rating scale (0=no tenderness, 10= extreme tenderness) | 31 patients were implanted. patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation. | Posted | Median | Inter-Quartile Range | units on a scale | 24 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 6 |
| 31 |
| Wound Dehiscence | Surgical and medical procedures | Non-systematic Assessment |
|
| Soft Tissue Necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| 24 months post operation |
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| Title | Measurements |
|---|---|
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| 24 months post operation |
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| Title | Measurements |
|---|---|
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| 6 months post operation |
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| 12 months post operation |
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| 24 months post operation |
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| Title | Measurements |
|---|---|
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| 6 months post operation |
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| 12 months post operation |
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| 24 months post operation |
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