Incisional Hernia
Conditions
Brief summary
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes (All Comers) through 24 months post repair.
Detailed description
This is a post-market, on-label study to understand the performance of the graft in the US.
Interventions
DEVICEXen Matrix AB
Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier.
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 willing and able to give written informed consent. * Subject must be diagnosed with a ventral or incisional midline hernia. * Mesh must be placed in the retro-rectus or intraperitoneal plane. * Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion criteria
* The use of surgical graft as a bridge repair. * The subject has more than 4 prior recurrences. * Subject has a contraindication for the placement of surgical graft. * Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible. * The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides). * Subject has intact permanent mesh adjacent to the current hernia to be repaired. * Subject has peritonitis at the time of surgery. * The subject is an active smoker within the last 2 weeks prior to surgery. * Clinically significant Chronic Obstructive Pulmonary Disease or heart failure, defined as marked limitation in ability or inability to perform activities of daily living. * Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study. * Chronic steroid use (\>6 months) or immunosuppression drugs. * Subject's body mass index (BMI) \>45 kg/m2. * Subject has cirrhosis, and/or ascites. * Subject has a defined collagen disorder. * Known to be infected with human immunodeficiency virus (HIV). * Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits Activities of Daily Living, is on hemodialysis or peritoneal dialysis. * Subject is American Society of Anesthesiology (ASA) Class 4 or 5. * Subject has a life expectancy \< 2 years at the time of enrollment. * Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study. * Subjects with known sensitivity to porcine products. * Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin). * Subject has any condition in the opinion of the Investigator that 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 Wound Occurrences Up to 45 Days Post Implantation | Up to 45 days post implantation | Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure | Within 6 months and 24 months of implantation procedure | — |
| Number of Participants With Reoperation Due to Index Hernia Repair | 24 months post implantation procedure | — |
| Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure | The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome. |
| Number of Participants With Wound Occurrences > 45 Days Post Implantation | Day 45 and up to 2 years post implantation | Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention. |
| Number of Participants Who Returned to Work Post Implantation Procedure | Up to 2 years following implantation procedure | — |
| Duration of Participants Stay in Hospital Following Implantation Procedure | From index procedure day to discharge from hospital day | — |
| General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | Baseline, 1, 3, 6, 12, 18, and 24 months post implantation | The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Treated With XenMatrix AB This group includes participants with a diagnosis of ventral or incisional midline hernia who have undergone the hernia surgical repair with the use of the XenMatrix AB. | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Subjects Treated With XenMatrix AB |
|---|---|
| Age, Continuous | 58.6 Years STANDARD_DEVIATION 12.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 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 | 3 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 75 |
| other Total, other adverse events | 55 / 75 |
| serious Total, serious adverse events | 31 / 75 |
Outcome results
Primary
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time frame: Up to 45 days post implantation
Population: The primary endpoint was wound occurrence within 45 days post implantation that required intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xen Matrix AB | Number of Participants With Wound Occurrences Up to 45 Days Post Implantation | 11 Participants |
Secondary
Duration of Participants Stay in Hospital Following Implantation Procedure
Time frame: From index procedure day to discharge from hospital day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xen Matrix AB | Duration of Participants Stay in Hospital Following Implantation Procedure | 6.7 Days | Standard Deviation 6.13 |
Secondary
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning.
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | Baseline | 47.7 score on a scale | Standard Deviation 11.14 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 1 month | 47.2 score on a scale | Standard Deviation 10.3 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 3 months | 48.6 score on a scale | Standard Deviation 10.28 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 6 months | 48.3 score on a scale | Standard Deviation 9.77 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 12 months | 48.3 score on a scale | Standard Deviation 11.06 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 18 months | 49.4 score on a scale | Standard Deviation 9.17 |
| Xen Matrix AB | General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. | 24 months | 47.9 score on a scale | Standard Deviation 9.49 |
Secondary
Number of Participants Who Returned to Work Post Implantation Procedure
Time frame: Up to 2 years following implantation procedure
Population: The overall number of participants (21) for this endpoint reflects the number of participants who were employed at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xen Matrix AB | Number of Participants Who Returned to Work Post Implantation Procedure | 17 Participants |
Secondary
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Time frame: Within 6 months and 24 months of implantation procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Xen Matrix AB | Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure | Within 6 Months | 0 Participants |
| Xen Matrix AB | Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure | Within 24 Months | 4 Participants |
Secondary
Number of Participants With Reoperation Due to Index Hernia Repair
Time frame: 24 months post implantation procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xen Matrix AB | Number of Participants With Reoperation Due to Index Hernia Repair | 8 Participants |
Secondary
Number of Participants With Wound Occurrences > 45 Days Post Implantation
Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time frame: Day 45 and up to 2 years post implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Xen Matrix AB | Number of Participants With Wound Occurrences > 45 Days Post Implantation | 15 Participants |
Secondary
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome.
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure
Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | Baseline | 1.6 Score on a scale | Standard Deviation 1.65 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 1 month | 1.4 Score on a scale | Standard Deviation 1.42 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 3 months | 1.2 Score on a scale | Standard Deviation 1.37 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 6 months | 0.9 Score on a scale | Standard Deviation 1.18 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 12 months | 0.8 Score on a scale | Standard Deviation 1.06 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 18 months | 0.8 Score on a scale | Standard Deviation 1.15 |
| Xen Matrix AB | Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure | 24 months | 0.6 Score on a scale | Standard Deviation 1.01 |