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

NCT ID: NCT02712398

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-11-15

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.

Conditions

Hernia, Ventral; Incisional Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phasix™ ST

Subjects treated with Phasix™ ST mesh

Group Type: EXPERIMENTAL

Phasix™ ST

Intervention Type: DEVICE

Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.

Interventions

Phasix™ ST

Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Hope, MD

Role: PRINCIPAL_INVESTIGATOR

New Hanover Regional Medical Center

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DVL-HE-017

Identifier Type: -

Identifier Source: org_study_id