Hernia, Ventral, Incisional Hernia
Conditions
Brief summary
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
Detailed description
Subjects at high risk are defined as having 1 or more of the following co-morbid 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
DEVICEPhasix™ ST
Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be 18 years of age or older * Subject must be willing to give written informed consent * Subject must be diagnosed with ventral or abdominal incisional hernia * Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST)) * Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use. * Subject is expected to meet the criteria for a Class I wound * Subjects must have 1 or more of the following pre-study conditions: 1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive 2. Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery) 3. COPD presence on patient self-report 4. Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5) 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
* Subject has had 4 or more previous hernia repairs (of the index hernia) * Subject's hernia is \> 350 cm2 * Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible * Subject has intact permanent mesh adjacent to the current hernia to be repaired * Preperitoneal placement of mesh * The subject is known to have a collagen disorder * The subject has peritonitis * The subject is on or suspected to be placed on chemotherapy medications during any part of the study * The subject's Body Mass Index (BMI) is \> 40 kg/m2 * The subject has cirrhosis of the liver and/or ascites * Subject is American Society of Anesthesiology Class 4 or 5 * Subject has a life expectancy of less than 2 years at the time of enrollment * Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements * Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) * Subject has an active or latent systemic infection * Patient has a contraindication to placement of mesh * Subject requires surgical bridge repair as the sole repair * Subject is pregnant or has plans to become pregnant during the study period * Subject has enrolled in another interventional clinical study within the last 30 days * Subject is part of the site personnel directly involved with this study * Subject has a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Occurrence Rate | 45 Days | Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence Rate | 24 Months | Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 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. |
| Pain Visual Analog Scale | 24 Months | Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up. |
| Device-related Adverse Event Incidence | 24 Months | Proportion of subjects with Investigator-determined device-related adverse events |
| Rate of Reoperation Due to Index Hernia Repair | 24 Months | Rate of reoperation due to the index hernia repair |
| Surgical Site Occurrence Rate | 3 months | Number of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. |
| Change in SF(Short-form)-12 | 24 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. Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported. |
| Surgical Procedure Time as Measured From Incision to Closure | During Procedure, up to 243 minutes | Surgical procedure time as measured from incision to closure (skin to skin) |
| Length of Hospital Stay | 1 month | Number of days admitted to the hospital for index surgery |
| Change in Carolinas Comfort Scale | 24 Months | Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phasix™ ST Subjects treated with Phasix™ ST mesh
Phasix™ ST: Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Re-operation | 21 |
| Overall Study | Sponsor Decision | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Phasix™ ST |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 36 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants |
| Age, Continuous | 55.0 Years STANDARD_DEVIATION 14.93 |
| BMI | 33.2 kg/m^2 STANDARD_DEVIATION 4.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 1 Participants |
| Race (NIH/OMB) White | 110 Participants |
| Region of Enrollment United States | 120 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 120 |
| other Total, other adverse events | 64 / 120 |
| serious Total, serious adverse events | 44 / 120 |
Outcome results
Primary
Surgical Site Occurrence Rate
Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.
Time frame: 45 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phasix™ ST | Surgical Site Occurrence Rate | 1 subjects |
Secondary
Change in Carolinas Comfort Scale
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-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: 24 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - Baseline | 1.15 units on a scale | Standard Deviation 1.059 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 1 Month | 0.85 units on a scale | Standard Deviation 0.938 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 3 Month | 0.34 units on a scale | Standard Deviation 0.601 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 6 Month | 0.22 units on a scale | Standard Deviation 0.523 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 12 Month | 0.13 units on a scale | Standard Deviation 0.353 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 18 Month | 0.17 units on a scale | Standard Deviation 0.377 |
| Phasix™ ST | Change in Carolinas Comfort Scale | Total CCS Score - 24 Month | 0.17 units on a scale | Standard Deviation 0.425 |
Secondary
Change in SF(Short-form)-12
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. Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.
Time frame: 24 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - Baseline | 44.38 score on a scale | Standard Deviation 9.635 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 1 Month | 40.35 score on a scale | Standard Deviation 9.349 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 3 Month | 48.83 score on a scale | Standard Deviation 8.026 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 6 Month | 49.99 score on a scale | Standard Deviation 8.277 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 12 Month | 50.10 score on a scale | Standard Deviation 8.248 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 18 Month | 50.48 score on a scale | Standard Deviation 8.794 |
| Phasix™ ST | Change in SF(Short-form)-12 | PCS - 24 Month | 48.02 score on a scale | Standard Deviation 9.739 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - Baseline | 53.47 score on a scale | Standard Deviation 9.493 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 1 Month | 40.35 score on a scale | Standard Deviation 9.349 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 3 Month | 48.83 score on a scale | Standard Deviation 8.026 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 6 Month | 49.99 score on a scale | Standard Deviation 8.277 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 12 Month | 50.10 score on a scale | Standard Deviation 8.248 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 18 Month | 50.48 score on a scale | Standard Deviation 8.794 |
| Phasix™ ST | Change in SF(Short-form)-12 | MCS - 24 Month | 48.02 score on a scale | Standard Deviation 9.739 |
Secondary
Device-related Adverse Event Incidence
Proportion of subjects with Investigator-determined device-related adverse events
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phasix™ ST | Device-related Adverse Event Incidence | 49 subjects |
Secondary
Hernia Recurrence Rate
Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 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.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ ST | Hernia Recurrence Rate | 38 Participants |
Secondary
Length of Hospital Stay
Number of days admitted to the hospital for index surgery
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ ST | Length of Hospital Stay | 1.0 days | Standard Deviation 1.35 |
Secondary
Pain Visual Analog Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ ST | Pain Visual Analog Scale | 0.94 centimeters | Standard Deviation 1.63 |
Secondary
Rate of Reoperation Due to Index Hernia Repair
Rate of reoperation due to the index hernia repair
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ ST | Rate of Reoperation Due to Index Hernia Repair | 22 Participants |
Secondary
Surgical Procedure Time as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Time frame: During Procedure, up to 243 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ ST | Surgical Procedure Time as Measured From Incision to Closure | 85.9 Minutes | Standard Deviation 43.03 |
Secondary
Surgical Site Occurrence Rate
Number of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phasix™ ST | Surgical Site Occurrence Rate | 0 subjects |