Ventral Hernia Clinical Trial
Official title:
A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Verified date | June 2024 |
Source | Integra LifeSciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 28, 2022 |
Est. primary completion date | December 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Surgical Healing Arts Center | Fort Myers | Florida |
Lead Sponsor | Collaborator |
---|---|
Integra LifeSciences Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | 90 days | |
Other | 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 | 90 days | |
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 | 90 days | |
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 | 90 days | |
Secondary | Incidence of Surgical Site Infections (SSIs) Post Index Procedure | Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure | 90 days | |
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 | 1 year | |
Secondary | Incidence of Hernia Recurrence Confirmed by Clinical Assessment | Percentage of subjects with a hernia recurrence confirmed by clinical assessment | 1 year | |
Secondary | Incidence of Reoperation Requirement Due to Index Repair | Percentage of subjects with a reoperation requirement due to index repair | 1 year |
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