N/A
N=28
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT05610267 ↗Enrolled (actual)
28
Serious AEs
10.7%
Results posted
Jun 2024
Primary outcome: Primary: Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Retrospective chart review (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure |
2 | — |
| SECONDARY Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure |
8 | — |
| SECONDARY Incidence of Surgical Site Infections (SSIs) Post Index Procedure |
4 | — |
| SECONDARY Incidence of Later Post-operative Complications After 90 Days Post Index Procedure |
4 | — |
| SECONDARY Incidence of Hernia Recurrence Confirmed by Clinical Assessment |
1 | — |
| SECONDARY Incidence of Reoperation Requirement Due to Index Repair |
4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)..
- Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.
Exclusion Criteria
- Subject has known allergy to porcine-derived products.
- 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.
- Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
- Subject had uncontrolled diabetes, defined as Hb1AC value >7% within 12 weeks prior to index procedure.
- Subject has been diagnosed with cirrhosis and/or ascites.
Data sourced from ClinicalTrials.gov (NCT05610267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.