Trial Outcomes & Findings for A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery (NCT NCT01863030)
NCT ID: NCT01863030
Last Updated: 2020-01-21
Results Overview
Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
COMPLETED
31 participants
up to 24 months post surgery
2020-01-21
Participant Flow
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.
Participant milestones
| Measure |
Phasix Mesh
Phasix mesh implant
|
|---|---|
|
Baseline
STARTED
|
31
|
|
Baseline
COMPLETED
|
31
|
|
Baseline
NOT COMPLETED
|
0
|
|
Follow up
STARTED
|
31
|
|
Follow up
2 Weeks
|
31
|
|
Follow up
3 Months
|
28
|
|
Follow up
6 Months
|
29
|
|
Follow up
12 Months
|
26
|
|
Follow up
24 Months
|
13
|
|
Follow up
COMPLETED
|
13
|
|
Follow up
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Baseline characteristics by cohort
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
|
BMI
|
33 kg/m^2
n=5 Participants
|
|
Employment Status
Employed
|
12 Participants
n=5 Participants
|
|
Employment Status
Unemployed/retired
|
11 Participants
n=5 Participants
|
|
Employment Status
Disabled
|
8 Participants
n=5 Participants
|
|
Employment Activity
Manual Labor
|
6 Participants
n=5 Participants
|
|
Employment Activity
Sedentary
|
5 Participants
n=5 Participants
|
|
Employment Activity
not employed
|
19 Participants
n=5 Participants
|
|
Employment Activity
Employment activity not answered
|
1 Participants
n=5 Participants
|
|
Past Medical History
Cancer
|
5 Participants
n=5 Participants
|
|
Past Medical History
Peripheral Vascular Disease
|
1 Participants
n=5 Participants
|
|
Past Medical History
Chronic Heart Failure/ Coronary Artery Disease
|
5 Participants
n=5 Participants
|
|
Past Medical History
GERD
|
12 Participants
n=5 Participants
|
|
Past Medical History
COPD
|
9 Participants
n=5 Participants
|
|
Past Medical History
Diabetes
|
8 Participants
n=5 Participants
|
|
Past Medical History
Genitourinary disease
|
5 Participants
n=5 Participants
|
|
Past Medical History
Mental Health Disease
|
4 Participants
n=5 Participants
|
|
Past Medical History
Chronic Pain
|
10 Participants
n=5 Participants
|
|
Number of Participants with History of Tobacco Use
|
7 Participants
n=5 Participants
|
|
Prior Abdominal Surgery
|
30 Participants
n=5 Participants
|
|
Prior Hernia Repair
|
14 Participants
n=5 Participants
|
|
Operation Duration
|
140 Minutes
n=5 Participants
|
|
CDC Wound Classification
Grade 1
|
30 Participants
n=5 Participants
|
|
CDC Wound Classification
Grade 2
|
1 Participants
n=5 Participants
|
|
Removal of Previous mesh during hernia repair procedure
|
4 Participants
n=5 Participants
|
|
Hernia Defect Size
|
105 cm2
n=5 Participants
|
|
Graft Size
|
592 cm2
n=5 Participants
|
|
Number of Grafts used
1 graft
|
30 Participants
n=5 Participants
|
|
Number of Grafts used
2 grafts
|
1 Participants
n=5 Participants
|
|
Number of Participants with Retro Rectus Mesh Placement
|
31 Participants
n=5 Participants
|
|
Component Separation Technique
Open CST
|
31 participants
n=5 Participants
|
|
Component Separation Technique
Endo CST
|
30 participants
n=5 Participants
|
|
Component Separation Technique
Posterior CST
|
18 participants
n=5 Participants
|
|
Component Separation Technique
Rives Stoppa
|
11 participants
n=5 Participants
|
|
Number of Participants with Posterior Rectus Sheath Approximation
|
31 Participants
n=5 Participants
|
|
Number of Participants with Anterior Rectus Sheath Approximation
|
31 Participants
n=5 Participants
|
|
Number of participants where PDS sutures were used during hernia repair procedure
|
31 Participants
n=5 Participants
|
|
Number of participants who had drains placed during hernia repair procedure
1 drain
|
10 participants
n=5 Participants
|
|
Number of participants who had drains placed during hernia repair procedure
2 drains
|
19 participants
n=5 Participants
|
|
Number of participants who had drains placed during hernia repair procedure
3 drains
|
2 participants
n=5 Participants
|
|
Number of participants who had a concurrent procedure
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 months post surgeryNumber of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Physical Component Summery
Baseline/ pre operation
|
38.9 units on a scale
Standard Deviation 10.0
|
|
Physical Component Summery
12 months post operation
|
47.2 units on a scale
Standard Deviation 9.7
|
|
Physical Component Summery
24 months post operation
|
43.9 units on a scale
Standard Deviation 9.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Role Emotional Quality of Life Outcome
Baseline/ pre operation
|
42.5 units on a scale
Standard Deviation 12.9
|
|
Role Emotional Quality of Life Outcome
12 months post operation
|
43.5 units on a scale
Standard Deviation 13.0
|
|
Role Emotional Quality of Life Outcome
24 months post operation
|
44.8 units on a scale
Standard Deviation 12.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Physical Functioning Quality of Life Outcome
Baseline/ pre operation
|
39.8 units on a scale
Standard Deviation 12.1
|
|
Physical Functioning Quality of Life Outcome
12 months post operation
|
46.4 units on a scale
Standard Deviation 11.6
|
|
Physical Functioning Quality of Life Outcome
24 months post operation
|
44.5 units on a scale
Standard Deviation 12.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Role Physical Quality of Life Outcome
Baseline/ pre operation
|
39.0 units on a scale
Standard Deviation 11.7
|
|
Role Physical Quality of Life Outcome
12 months post operation
|
46.1 units on a scale
Standard Deviation 44.2
|
|
Role Physical Quality of Life Outcome
24 months post operation
|
44.2 units on a scale
Standard Deviation 11.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Bodily Pain Quality of Life Outcome
Baseline/ pre operation
|
38.5 units on a scale
Standard Deviation 12.7
|
|
Bodily Pain Quality of Life Outcome
12 months post operation
|
45.9 units on a scale
Standard Deviation 11.1
|
|
Bodily Pain Quality of Life Outcome
24 months post operation
|
44.5 units on a scale
Standard Deviation 13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
General Health Quality of Life Outcome
Baseline/ pre operation
|
43.3 units on a scale
Standard Deviation 91
|
|
General Health Quality of Life Outcome
12 months post operation
|
50.7 units on a scale
Standard Deviation 10.4
|
|
General Health Quality of Life Outcome
24 months post operation
|
43.9 units on a scale
Standard Deviation 12.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Mental Component Summery
Baseline/ pre operation
|
46.5 units on a scale
Standard Deviation 11.7
|
|
Mental Component Summery
12 months post operation
|
48.3 units on a scale
Standard Deviation 9.8
|
|
Mental Component Summery
24 months post operation
|
47.9 units on a scale
Standard Deviation 10.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Vitality Quality of Life Outcome
Baseline/ pre operation
|
45.3 units on a scale
Standard Deviation 12.1
|
|
Vitality Quality of Life Outcome
12 months post operation
|
50.2 units on a scale
Standard Deviation 9.8
|
|
Vitality Quality of Life Outcome
24 months post operation
|
47.1 units on a scale
Standard Deviation 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Social Functioning Quality of Life Outcome
Baseline/ pre operation
|
43.4 units on a scale
Standard Deviation 12.1
|
|
Social Functioning Quality of Life Outcome
12 months post operation
|
47.0 units on a scale
Standard Deviation 11.3
|
|
Social Functioning Quality of Life Outcome
24 months post operation
|
48.6 units on a scale
Standard Deviation 9.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 months, 24 monthsPopulation: 31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.
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.
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Mental Health Quality of Life Outcome
Baseline/ pre operation
|
45.3 units on a scale
Standard Deviation 13.3
|
|
Mental Health Quality of Life Outcome
12 months post operation
|
50.3 units on a scale
Standard Deviation 8.5
|
|
Mental Health Quality of Life Outcome
24 months post operation
|
47.0 units on a scale
Standard Deviation 14.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsAbdominal 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 months post surgerAbdominal 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
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: up to 24 months post surgeryPopulation: 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.
Pain rating on a numeric rating scale (0=no pain, 10=extreme pain)
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Pain Assessment
2 weeks post operation
|
4.0 units on a scale
Interval 2.0 to 6.0
|
|
Pain Assessment
3 months post operation
|
1.0 units on a scale
Interval 1.0 to 4.0
|
|
Pain Assessment
6 months post operation
|
1.0 units on a scale
Interval 1.0 to 2.0
|
|
Pain Assessment
12 months post operation
|
1.0 units on a scale
Interval 1.0 to 3.8
|
|
Pain Assessment
24 months post operation
|
2.5 units on a scale
Interval 1.0 to 5.5
|
POST_HOC outcome
Timeframe: 24 monthsPopulation: 31 patients were implanted. patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation.
Tenderness measure on a numeric rating scale (0=no tenderness, 10= extreme tenderness)
Outcome measures
| Measure |
Phasix Mesh
n=31 Participants
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Tenderness Assessment
24 months post operation
|
1.0 units on a scale
Interval 1.0 to 1.0
|
|
Tenderness Assessment
2 weeks post operation
|
3.0 units on a scale
Interval 1.0 to 4.0
|
|
Tenderness Assessment
3 months post operation
|
1.0 units on a scale
Interval 1.0 to 2.0
|
|
Tenderness Assessment
6 months post operation
|
1.0 units on a scale
Interval 1.0 to 3.0
|
|
Tenderness Assessment
12 months post operation
|
1.0 units on a scale
Interval 1.0 to 1.0
|
Adverse Events
Phasix Mesh
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phasix Mesh
n=31 participants at risk
Mesh being used for approved use. Mesh for ventral and incisional hernias.
Phasix mesh implant
|
|---|---|
|
Surgical and medical procedures
Seroma
|
12.9%
4/31 • Number of events 4 • 3 years, 3 months, 9 days
|
|
Surgical and medical procedures
Wound Dehiscence
|
3.2%
1/31 • Number of events 1 • 3 years, 3 months, 9 days
|
|
Skin and subcutaneous tissue disorders
Soft Tissue Necrosis
|
3.2%
1/31 • Number of events 1 • 3 years, 3 months, 9 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place