Incisional Hernia, Ventral Hernia
Conditions
Brief summary
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Detailed description
Pilot Study of patients across all wound classes for recurrence
Interventions
DEVICEResorbable Mesh
Phasix Mesh
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 or subject's legally authorized representative must be willing to give written informed consent * Subject must be diagnosed with ventral or incisional hernia * Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion criteria
* Subject is an active smoker (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). * Subject's hernia has recurred four or more times. * Subject's body mass index (BMI) \>40 kg/m2. * Subject has peritonitis. * Subject is on or suspected to be placed on chemotherapy medications during any part of the study. * Chronic steroid use or immunosuppression drugs (\> 6 months). * Subject has cirrhosis, and/or ascites. * Subject is American Society of Anesthesiology Class 4 or 5. * Subject is pregnant or planning to become pregnant during the course of the study. * Subject is known to be infected with human immunodeficiency virus (HIV). * Subject has a life expectancy of less than 2 years at the time of enrollment. * Subject has been treated with an investigational product in the past 30 days. * Subject is part of the site personnel directly involved with this study * Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hernia Recurrence | 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months | A recurrent hernia was 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 were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carolinas Comfort Scale (CCS) Total Score - Change From Baseline | Baseline and 24 months postoperative | The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline. |
| Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) | Baseline and 24 months postoperative | Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It yields 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. The change was calculated as the mean value at 24 months minus the mean value at baseline. |
| Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) | Baseline and 24 months postoperative | Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It 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. The change was calculated as the mean value at 24 months minus the mean value at baseline. |
| Surgical Procedure Time | Duration of index procedure (mean of 242.5 mins) | Measured from incision to closure (skin to skin). |
| Number of Participants With Device Related Adverse Events | 24 Months | In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. |
| Number of Study Related Post Operative Surgical Procedures | 24 Months | — |
| Number of Study Related Post Operative New Hospital Admissions | 24 Months | — |
| Number of Related Post-operative Visits Unrelated to Standard of Care | 24 Months | — |
| Incidence of Seroma | 24 Months | — |
| Length of Hospital Stay | 10 Months | Measured from end of index procedure to hospital discharge |
Countries
United States
Participant flow
Pre-assignment details
Of 33 subjects enrolled, 8 were not treated with the study device: a contraindication to the placement of mesh was present in 4 subjects; complete removal of existing mesh from a prior hernia repair (in the same affected area) was not possible in 3 subjects; and 1 subject had an active or latent systemic infection.
Participants by arm
| Arm | Count |
|---|---|
| Resorbable Mesh Phasix Mesh
Resorbable Mesh: Phasix Mesh | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Resorbable Mesh |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 17.12 |
| Body Mass Index | 30.3 kg/m^2 STANDARD_DEVIATION 5.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 166.9 cm STANDARD_DEVIATION 7.53 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 84.3 kg STANDARD_DEVIATION 17.16 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 6 / 25 |
| serious Total, serious adverse events | 6 / 25 |
Outcome results
Primary
Number of Participants With Hernia Recurrence
A recurrent hernia was 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 were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Time frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 1 Month | 0 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 3 Months | 0 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 6 Months | 0 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 12 Months | 1 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 18 Months | 0 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | 24 Months | 0 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | >24 Months | 1 Participants |
| Resorbable Mesh | Number of Participants With Hernia Recurrence | Post Op to End of Study | 2 Participants |
Secondary
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time frame: Baseline and 24 months postoperative
Population: All participants with non-missing values at both baseline and respective post procedure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resorbable Mesh | Carolinas Comfort Scale (CCS) Total Score - Change From Baseline | -1.1 units on a scale | Standard Deviation 1.12 |
Secondary
Incidence of Seroma
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resorbable Mesh | Incidence of Seroma | 1 events |
Secondary
Length of Hospital Stay
Measured from end of index procedure to hospital discharge
Time frame: 10 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resorbable Mesh | Length of Hospital Stay | 5.0 days | Standard Deviation 4.04 |
Secondary
Number of Participants With Device Related Adverse Events
In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resorbable Mesh | Number of Participants With Device Related Adverse Events | 1 Participants |
Secondary
Number of Related Post-operative Visits Unrelated to Standard of Care
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resorbable Mesh | Number of Related Post-operative Visits Unrelated to Standard of Care | 8 events |
Secondary
Number of Study Related Post Operative New Hospital Admissions
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resorbable Mesh | Number of Study Related Post Operative New Hospital Admissions | 5 events |
Secondary
Number of Study Related Post Operative Surgical Procedures
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resorbable Mesh | Number of Study Related Post Operative Surgical Procedures | 7 events |
Secondary
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It 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. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time frame: Baseline and 24 months postoperative
Population: All participants with non-missing values at both baseline and respective post procedure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resorbable Mesh | Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) | -9.4 units on a scale | Standard Deviation 9.21 |
Secondary
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
Short Form (SF)-12 Version 2 is a multipurpose, 12-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. It yields 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. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time frame: Baseline and 24 months postoperative
Population: All participants with non-missing values at both baseline and respective post procedure assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resorbable Mesh | Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) | -5.3 units on a scale | Standard Deviation 9.98 |
Secondary
Surgical Procedure Time
Measured from incision to closure (skin to skin).
Time frame: Duration of index procedure (mean of 242.5 mins)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resorbable Mesh | Surgical Procedure Time | 242.5 minutes | Standard Deviation 132.2 |