Hernia, Hernia, Abdominal, Hernia, Incisional
Conditions
Brief summary
The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
Detailed description
Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.
Interventions
DEVICEPhasix™ Mesh
A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
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 diagnosed with incisional midline hernia. * Subject has a VHWG Grade 3 hernia (as defined in the protocol). * Size of hernia ≥ 10 cm2. * Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.
Exclusion criteria
* Subject with \> 4 previous repairs of the hernia under observation. * Body Mass Index (BMI) \> 35 kg/m2. * The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study. * The subject has peritonitis. * Known human immunodeficiency virus (HIV) infection (if documented in the subject's record). * The subject has cirrhosis of the liver and/or ascites. * Subject is American Society of Anesthesiology Class 4 or 5. * Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible. * The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides). * Subject has intact permanent mesh adjacent to the current hernia to be repaired. * Subject's hernia repair requires intraabdominal mesh placement. * Surgical technique requires surgical bridge repair as the sole repair. * 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 is pregnant or has plans to become pregnant during the study period or is currently breastfeeding. * Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit. * Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature. * Subject is part of the site personnel directly involved with this study. * Subject has a life expectancy of less than 2 years at the time of enrollment. * Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure | 3 Months | Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\> |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Hernia Recurrence | 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. |
| Number of Participants With One or More Surgical Site Infection | 24 Months | Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 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 US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections. |
| Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale | 24 Months | Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low 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. A negative score means a decrease in pain perception. |
| Number of Participants With One or More Device-related Adverse Event | 24 Months | Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event. |
| Number of Participants Requiring Reoperation Due to Index Hernia Repair | 24 Months | Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair. |
| Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure | 24 Months | Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\> |
| Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure | 24 Months | Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life. |
| Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure | 1 day | Surgical procedure time as measured from incision to closure (skin to skin) |
| Mean Time Until Participants Were Able to Return to Work | 24 Months | The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery. |
| Mean Length of Hospital Stay Related to Index Procedure | 1 Month | The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well. |
| Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure | 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 1-Month follow-up, at 3-Month follow-up, at 12-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
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, United Kingdom
Participant flow
Recruitment details
Study subjects were enrolled between 22-Mar-2016 and 26-Apr-2017 at 15 different sites in 8 European countries.
Participants by arm
| Arm | Count |
|---|---|
| Phasix™ Mesh Patients treated with Phasix™ Mesh for hernia repair
Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB) | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Phasix Mesh explanted | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | unable due to non-study-related illness | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Phasix™ Mesh |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 12.41 |
| BMI | 27.8 kg/m^2 STANDARD_DEVIATION 4.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 11 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Region of Enrollment Austria | 3 participants |
| Region of Enrollment Belgium | 25 participants |
| Region of Enrollment Denmark | 10 participants |
| Region of Enrollment France | 11 participants |
| Region of Enrollment Germany | 12 participants |
| Region of Enrollment Italy | 3 participants |
| Region of Enrollment Netherlands | 14 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 84 |
| other Total, other adverse events | 35 / 84 |
| serious Total, serious adverse events | 40 / 84 |
Outcome results
Primary
Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ Mesh | Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure | 22 Participants |
Secondary
Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low 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. A negative score means a decrease in pain perception.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ Mesh | Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale | -0.7 score on a scale | Standard Deviation 2.45 |
Secondary
Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure
Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ Mesh | Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure | 0.11 score on a scale | Standard Deviation 0.22 |
Secondary
Mean Length of Hospital Stay Related to Index Procedure
The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well.
Time frame: 1 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phasix™ Mesh | Mean Length of Hospital Stay Related to Index Procedure | Days in the Ward | 9.5 days | Standard Deviation 5.87 |
| Phasix™ Mesh | Mean Length of Hospital Stay Related to Index Procedure | Total Length of Hospital Stay | 10.9 days | Standard Deviation 7.61 |
| Phasix™ Mesh | Mean Length of Hospital Stay Related to Index Procedure | Days in Intensive Care Unit | 1.0 days | Standard Deviation 3.16 |
| Phasix™ Mesh | Mean Length of Hospital Stay Related to Index Procedure | Days in Step Down (medium care) unit | 0.3 days | Standard Deviation 2.18 |
Secondary
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure
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 1-Month follow-up, at 3-Month follow-up, at 12-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™ Mesh | Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure | Total CCS Score at 3-Months | 0.5 score on a scale | Standard Deviation 0.84 |
| Phasix™ Mesh | Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure | Total CCS Score at 1-Month | 0.6 score on a scale | Standard Deviation 0.8 |
| Phasix™ Mesh | Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure | Total CCS Score at 12-Months | 0.3 score on a scale | Standard Deviation 0.62 |
| Phasix™ Mesh | Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure | Total CCS Score at 24-Months | 0.3 score on a scale | Standard Deviation 0.66 |
Secondary
Mean Surgical Procedure Time of the Index Procedure 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) | Dispersion |
|---|---|---|---|
| Phasix™ Mesh | Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure | 198 minutes | Standard Deviation 110.86 |
Secondary
Mean Time Until Participants Were Able to Return to Work
The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery.
Time frame: 24 Months
Population: Of the 84 enrolled subjects, only 26 were employed at the time of the index surgery and of these 23 went back to work.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phasix™ Mesh | Mean Time Until Participants Were Able to Return to Work | 101.3 days | Standard Deviation 160.38 |
Secondary
Number of Participants Requiring Reoperation Due to Index Hernia Repair
Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ Mesh | Number of Participants Requiring Reoperation Due to Index Hernia Repair | 13 Participants |
Secondary
Number of Participants With a Hernia Recurrence
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™ Mesh | Number of Participants With a Hernia Recurrence | 8 Participants |
Secondary
Number of Participants With One or More Device-related Adverse Event
Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ Mesh | Number of Participants With One or More Device-related Adverse Event | 16 Participants |
Secondary
Number of Participants With One or More Surgical Site Infection
Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 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 US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ Mesh | Number of Participants With One or More Surgical Site Infection | 12 Participants |
Secondary
Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure
Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phasix™ Mesh | Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure | 22 Participants |