Clinical trial NCT02712398: A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair
Official title: A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Incisional Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive
  2. 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)
  3. COPD presence on patient self-report
  4. Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
  5. Immunosuppression
  6. Coronary Artery Disease
  7. Chronic corticosteroid use: greater than 6 months systemic use
  8. Serum albumin less than 3.4 g/dL
  9. Advanced age: 75 years or older
  10. Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

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
* Subject is American Society of Anesthesiology Class 4 or 5
* Subject has a life expectancy of less than 2 years at the time of enrollment
* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
* Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated)
* Subject has an active or latent systemic infection
* Patient has a contraindication to placement of mesh
* Subject requires surgical bridge repair as the sole repair
* Subject is pregnant or has plans to become pregnant during the study period
* Subject has enrolled in another interventional clinical study within the last 30 days
* Subject is part of the site personnel directly involved with this study
* Subject has a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).

Primary outcomes:
measure: Surgical Site Occurrence Rate
timeFrame: 45 Days
Secondary outcomes:
measure: Surgical Site Occurrence Rate
timeFrame: 3 months
measure: Hernia Recurrence Rate
timeFrame: 24 Months
measure: Pain Visual Analog Scale
timeFrame: 24 Months
measure: Device-related Adverse Event Incidence
timeFrame: 24 Months
measure: Rate of Reoperation Due to Index Hernia Repair
timeFrame: 24 Months
measure: Change in Carolinas Comfort Scale
timeFrame: 24 Months
measure: Change in SF(Short-form)-12
timeFrame: 24 Months
measure: Surgical Procedure Time as Measured From Incision to Closure
timeFrame: During Procedure, up to 243 minutes
measure: Length of Hospital Stay
timeFrame: 1 month
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Medical Center
state: Connecticut
city: Celebration
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Wichita
country: United States
facility: Via-Christi Hospital
state: Kansas
city: Georgetown
country: United States
facility: Georgetown Community Hospital
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Methodist Hospital
state: Nebraska
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Portland
country: United States
facility: Legacy Emanuel Hospital
state: Oregon
city: Hershey
country: United States
facility: Hershey Penn State Medical Center
state: Pennsylvania
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: New Hanover Regional Medical Center
name: William Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: