A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair

Completed · Not applicable

Conditions studied: Hernia, Ventral, Incisional Hernia

In brief

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).

Key facts

Study ID

NCT02712398

Run by

C. R. Bard

People needed

120

Starts

2016-04-01

Expected to finish

2019-11-15

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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)
• Immunosuppression
• Coronary Artery Disease
• Chronic corticosteroid use: greater than 6 months systemic use
• Serum albumin less than 3.4 g/dL
• Advanced age: 75 years or older
• Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

You may not qualify if…

• 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).

Where it is running

• Yale-New Haven Medical Center — New Haven, Connecticut, United States
• Florida Hospital — Celebration, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Via-Christi Hospital — Wichita, Kansas, United States
• Georgetown Community Hospital — Georgetown, Kentucky, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Washington University — St Louis, Missouri, United States
• Methodist Hospital — Omaha, Nebraska, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• Legacy Emanuel Hospital — Portland, Oregon, United States
• Hershey Penn State Medical Center — Hershey, Pennsylvania, United States
• Carilion Clinic — Roanoke, Virginia, United States
• Overlake Hospital — Bellevue, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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