The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.
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 from a sub-population of twenty-one participants from the previous T-GENVIH-002 study, specifically those with laparoscopic or robotic repair. Prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in T-GENVIH-002 to present.
Study Type
OBSERVATIONAL
Enrollment
8
Integra® Gentrix® Surgical Matrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic \& reconstructive surgery.
Surgical Healing Arts
Fort Myers, Florida, United States
Number of Participants With Clinically Confirmed Recurrence
1\. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Time frame: Through study completion, an average of 4 months.
Self-Reported Recurrence
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
Time frame: Through study completion, an average of 4 months.
Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)
Incidence of Surgical Site Occurrences requiring Procedural Intervention (SSOPI) of the primary hernia repair to date, including not previously reported in T-GENVIH-002.
Time frame: Through study completion, an average of 4 months.
Number of Participants With Surgical Site Occurrences (SSOs)
Incidence of Surgical Site Occurrences (SSOs) of the primary hernia repair to date (seroma, abscess, dehiscence, hematoma, wound necrosis, ileus, fistula, delayed wound healing), including not previously reported in T-GENVIH-002 study.
Time frame: Through study completion, an average of 4 months.
Number of Subjects With Surgical Site Infections (SSIs)
Incidence of Surgical Site Infections (SSIs) post primary hernia repair to date, including not previously reported in T-GENVIH-002 study.
Time frame: Through study completion, an average of 4 months.
Number of Participants With Self-Reported Recurrence
Incidence of self-reported recurrence (i.e., bulge) of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
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Time frame: Through study completion, an average of 4 months.