Ventral Hernia
Conditions
Brief summary
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
Detailed description
Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.
Interventions
The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection).. 2. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.
Exclusion criteria
1. Subject has known allergy to porcine-derived products. 2. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position. 3. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection. 4. Subject had uncontrolled diabetes, defined as Hb1AC value \>7% within 12 weeks prior to index procedure. 5. Subject has been diagnosed with cirrhosis and/or ascites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure | 90 days | Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure | 90 days | Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure |
| Incidence of Surgical Site Infections (SSIs) Post Index Procedure | 90 days | Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure |
| Incidence of Later Post-operative Complications After 90 Days Post Index Procedure | 1 year | Percentage of subjects with a later post-operative complications after 90 days post index procedure |
| Incidence of Hernia Recurrence Confirmed by Clinical Assessment | 1 year | Percentage of subjects with a hernia recurrence confirmed by clinical assessment |
| Incidence of Reoperation Requirement Due to Index Repair | 1 year | Percentage of subjects with a reoperation requirement due to index repair |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days) | 90 days | Number of days between the date of the index procedure and the date of the hospital discharge |
| Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled | 90 days | Number of subjects who used opioids following the procedure based on the concomitants medication |
Countries
United States
Participant flow
Recruitment details
The retrospective chart review including the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for a chart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and September 1, 2022 (90 days prior to the start of data collection) started in November 2022 and ended in december 2022. The enrollment occured at a single Surgical center.
Pre-assignment details
29 subjects screened, 1 subject, screened failure. 28 subjects, male and female were enrolled and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Device: Retrospective Chart Review Subject has undergone abdominal wall reconstruction for a hernia with Integra Gentrix® Surgical Matrix. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Device: Retrospective Chart Review |
|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 12.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 13 / 28 |
| serious Total, serious adverse events | 3 / 28 |
Outcome results
Primary
Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
Percentage of subjects with a post-operative complications requiring procedural intervention within 90 days post index procedure
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure | 2 Participants |
Secondary
Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure
Percentage of subjects with an early post-operative complications (Surgical Site Occurrences (SSOs)) within 90 days post index procedure
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure | 8 Participants |
Secondary
Incidence of Hernia Recurrence Confirmed by Clinical Assessment
Percentage of subjects with a hernia recurrence confirmed by clinical assessment
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Hernia Recurrence Confirmed by Clinical Assessment | 1 Participants |
Secondary
Incidence of Later Post-operative Complications After 90 Days Post Index Procedure
Percentage of subjects with a later post-operative complications after 90 days post index procedure
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Later Post-operative Complications After 90 Days Post Index Procedure | 4 Participants |
Secondary
Incidence of Reoperation Requirement Due to Index Repair
Percentage of subjects with a reoperation requirement due to index repair
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Reoperation Requirement Due to Index Repair | 4 Participants |
Secondary
Incidence of Surgical Site Infections (SSIs) Post Index Procedure
Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Incidence of Surgical Site Infections (SSIs) Post Index Procedure | 4 Participants |
Other Pre-specified
Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)
Number of days between the date of the index procedure and the date of the hospital discharge
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device: Retrospective Chart Review | Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days) | 2.8 Days | Standard Deviation 2.55 |
Other Pre-specified
Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled
Number of subjects who used opioids following the procedure based on the concomitants medication
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Retrospective Chart Review | Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled | 24 Participants |