Clinical trial NCT05610267: Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Official title: A Retrospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-09
Enrollment: 28
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Post-operative Complications Requiring Procedural Intervention Within 90 Days Post Index Procedure
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of Early Post-operative Complications (Surgical Site Occurrences (SSOs)) Within 90 Days Post Index Procedure
timeFrame: 90 days
measure: Incidence of Surgical Site Infections (SSIs) Post Index Procedure
timeFrame: 90 days
measure: Incidence of Later Post-operative Complications After 90 Days Post Index Procedure
timeFrame: 1 year
measure: Incidence of Hernia Recurrence Confirmed by Clinical Assessment
timeFrame: 1 year
measure: Incidence of Reoperation Requirement Due to Index Repair
timeFrame: 1 year
Other outcomes:
measure: Average Length of Hospital Stay (LOS) Post Index Procedure (Measured in Days)
timeFrame: 90 days
measure: Rate of Opioid Usage Following Procedure Determined by % of Prescriptions Filled and Refilled
timeFrame: 90 days
Locations:
city: Fort Myers
country: United States
facility: Surgical Healing Arts Center
state: Florida
Study officials:
affiliation: Integra LifeSciences Corporation
name: Adam Young, MD
role: STUDY_DIRECTOR
References: