A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair

C. R. Bard16 sites in 1 country120 target enrollmentApril 2016

ConditionsHernia, Ventral Incisional Hernia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hernia, Ventral
Sponsor: C. R. Bard
Enrollment: 120
Locations: 16
Primary Endpoint: Surgical Site Occurrence Rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).

Detailed Description

Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

November 15, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be 18 years of age or older
•Subject must be willing to give written informed consent
•Subject must be diagnosed with ventral or abdominal incisional hernia
•Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
•Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
•Subject is expected to meet the criteria for a Class I wound
•Subjects must have 1 or more of the following pre-study conditions:
•Body Mass Index (BMI) between 30-40 kg/m2, inclusive
•Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery)
•COPD presence on patient self-report

Exclusion Criteria

•Subject has had 4 or more previous hernia repairs (of the index hernia)
•Subject's hernia is \> 350 cm2
•Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
•Subject has intact permanent mesh adjacent to the current hernia to be repaired
•Preperitoneal placement of mesh
•The subject is known to have a collagen disorder
•The subject has peritonitis
•The subject is on or suspected to be placed on chemotherapy medications during any part of the study
•The subject's Body Mass Index (BMI) is \> 40 kg/m2
•The subject has cirrhosis of the liver and/or ascites

Outcomes

Primary Outcomes

Surgical Site Occurrence Rate

Time Frame: 45 Days

Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.

Secondary Outcomes

Surgical Site Occurrence Rate(3 months)
Hernia Recurrence Rate(24 Months)
Pain Visual Analog Scale(24 Months)
Device-related Adverse Event Incidence(24 Months)
Rate of Reoperation Due to Index Hernia Repair(24 Months)
Change in Carolinas Comfort Scale(24 Months)
Change in SF(Short-form)-12(24 Months)
Surgical Procedure Time as Measured From Incision to Closure(During Procedure, up to 243 minutes)
Length of Hospital Stay(1 month)