Incisional Hernia, Ventral Hernia
Conditions
Brief summary
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
Detailed description
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Interventions
DEVICEResorbable Mesh
Phasix Mesh
Sponsors
FGK Clinical Research GmbH
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must have met all of the criteria listed below to be enrolled in the study: 1\. Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions: 1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive 2. Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery) 3. COPD presence on patient self-report 4. Diabetes mellitus 5. Immunosuppression 6. Coronary Artery Disease 7. Chronic corticosteroid use: greater than 6 months systemic use 8. Serum albumin less than 3.4 g/dL 9. Advanced age: 75 years or older 10. Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
Exclusion criteria
Subjects were excluded from study enrollment if any of the following criteria were met: 1\. Subject's hernia had recurred more than once (protocol version 1.4) 1. Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0) 2. The subject had peritonitis 3. The subject was on or suspected to be placed on chemotherapy medications during any part of the study 4. The subject's Body Mass Index (BMI) was greater than 40 kg/m2 5. The subject had cirrhosis of the liver and/or ascites 6. Subject was American Society of Anesthesiology Class 4 or 5 7. Subject was known to be infected with human immunodeficiency virus (HIV) 8. Subject had a life expectancy of less than 2 years at the time of enrollment 9. Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements 10. Subject's hernia repair utilized intraabdominal mesh placement 11. Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol) 12. Subject had an active or latent systemic infection 13. Subject required surgical bridge repair as the sole repair 14. Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding 15. Subject had enrolled in another clinical study within the last 30 days 16. Subject was part of the site personnel directly involved with this study 17. Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence Rate | 60 Months | Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. |
| Surgical Site Infections | 60 Months | Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Re-operation Due to the Index Hernia Repair | 60 Months | Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair. |
| Carolinas Comfort Scale® (CCS) | 60 Months | Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results. |
| Pain Visual Analog Scale | 60 Months | Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception. |
| Surgical Procedure Time as Measured From Incision to Closure | 1 day | Surgical procedure time as measured from incision to closure (skin to skin) |
| Length of Hospital Stay | 35 days | Time in days from hospital admission to discharge |
| SF-12 Questionnaire | 60 Months | The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Device Related Adverse Events | 60 Months | Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term incidence is an error and is reported here as the rate of device related adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phasix Mesh Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (\>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL). | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Moved to area without study site | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Re-operation | 17 |
| Overall Study | Sponsor decision | 2 |
| Overall Study | Unable to meet follow-up requirements | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Phasix Mesh |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 12 |
| BMI | 32.24 kg/m^2 STANDARD_DEVIATION 4.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 116 Participants |
| Region of Enrollment United States | 121 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 121 |
| other Total, other adverse events | 104 / 121 |
| serious Total, serious adverse events | 49 / 121 |
Outcome results
Primary
Hernia Recurrence Rate
Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix Mesh | Hernia Recurrence Rate | 20 Participants |
Primary
Surgical Site Infections
Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix Mesh | Surgical Site Infections | 11 Participants |
Secondary
Carolinas Comfort Scale® (CCS)
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
Time frame: 60 Months
Population: The number of participants noted at each time point differ from the overall number (121) due to only having the eligible questionnaires being analyzed. The number of eligible questionnaires range from 52 to 111.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 1 Month | 31.2 Score on a scale | Standard Error 23.3 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 3 Month | 18.5 Score on a scale | Standard Error 20.9 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 6 Month | 14.1 Score on a scale | Standard Error 20.7 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 12 Month | 11.6 Score on a scale | Standard Error 21.1 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 18 Month | 8.4 Score on a scale | Standard Error 16.6 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 24 Month | 10.5 Score on a scale | Standard Error 20.7 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 36 Month | 9.8 Score on a scale | Standard Error 21.4 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 48 Month | 9.8 Score on a scale | Standard Error 21.4 |
| Phasix Mesh | Carolinas Comfort Scale® (CCS) | Total CCS Score at 60 Month | 4.9 Score on a scale | Standard Error 14.2 |
Secondary
Device Related Adverse Events
Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term incidence is an error and is reported here as the rate of device related adverse events.
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix Mesh | Device Related Adverse Events | 19 Participants |
Secondary
Length of Hospital Stay
Time in days from hospital admission to discharge
Time frame: 35 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phasix Mesh | Length of Hospital Stay | 4 Days |
Secondary
Pain Visual Analog Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.
Time frame: 60 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix Mesh | Pain Visual Analog Scale | -3.16 cm | Standard Deviation 3.35 |
Secondary
Rate of Re-operation Due to the Index Hernia Repair
Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix Mesh | Rate of Re-operation Due to the Index Hernia Repair | 18 Participants |
Secondary
SF-12 Questionnaire
The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: 60 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 1 | -2.700 Absolute Change from Baseline | Standard Deviation 9.999 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 3 | 5.374 Absolute Change from Baseline | Standard Deviation 8.951 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 6 | 6.943 Absolute Change from Baseline | Standard Deviation 9.352 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 12 | 6.868 Absolute Change from Baseline | Standard Deviation 10.986 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 18 | 7.589 Absolute Change from Baseline | Standard Deviation 11.416 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 24 | 6.206 Absolute Change from Baseline | Standard Deviation 10.442 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 36 | 7.101 Absolute Change from Baseline | Standard Deviation 9.652 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 48 | 7.206 Absolute Change from Baseline | Standard Deviation 12.045 |
| Phasix Mesh | SF-12 Questionnaire | PCS - Month 60 | 7.374 Absolute Change from Baseline | Standard Deviation 9.997 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 1 | 0.546 Absolute Change from Baseline | Standard Deviation 10.304 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 3 | 3.287 Absolute Change from Baseline | Standard Deviation 9.822 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 6 | 3.311 Absolute Change from Baseline | Standard Deviation 9.911 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 12 | 2.124 Absolute Change from Baseline | Standard Deviation 9.648 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 18 | 2.015 Absolute Change from Baseline | Standard Deviation 11.183 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 24 | 2.769 Absolute Change from Baseline | Standard Deviation 9.841 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 36 | -0.239 Absolute Change from Baseline | Standard Deviation 11.142 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 48 | 2.393 Absolute Change from Baseline | Standard Deviation 10.24 |
| Phasix Mesh | SF-12 Questionnaire | MCS - Month 60 | 3.248 Absolute Change from Baseline | Standard Deviation 10.782 |
Secondary
Surgical Procedure Time as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phasix Mesh | Surgical Procedure Time as Measured From Incision to Closure | 168 Minutes |