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.
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.
Study Type
OBSERVATIONAL
Enrollment
28
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).
Surgical Healing Arts Center
Fort Myers, Florida, United States
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
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
Incidence of Surgical Site Infections (SSIs) Post Index Procedure
Percentage of subjects with Surgical Site Infections (SSIs) Post index procedure
Time frame: 90 days
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
Incidence of Hernia Recurrence Confirmed by Clinical Assessment
Percentage of subjects with a hernia recurrence confirmed by clinical assessment
Time frame: 1 year
Incidence of Reoperation Requirement Due to Index Repair
Percentage of subjects with a reoperation requirement due to index repair
Time frame: 1 year
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