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

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

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).

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral; Incisional Hernia
• Intervention / Treatment: Device: Phasix™ ST

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Medical Center
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via-Christi Hospital
  • Kentucky
    • Georgetown, Kentucky, United States, 40324
      • Georgetown Community Hospital
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Regional Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Hospital
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Emanuel Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Penn State Medical Center
  • Virginia
    • Roanoke, Virginia, United States, 24013
      • Carilion Clinic
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phasix™ ST; Subjects treated with Phasix™ ST mesh	Device: Phasix™ ST; Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Occurrence Rate	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.	45 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Occurrence Rate	Number of subjects with Surgical Site Occurrences, 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 3 months.	3 months
Hernia Recurrence Rate	Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.	24 Months
Pain Visual Analog Scale	Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up.	24 Months
Device-related Adverse Event Incidence	Proportion of subjects with Investigator-determined device-related adverse events	24 Months
Rate of Reoperation Due to Index Hernia Repair	Rate of reoperation due to the index hernia repair	24 Months
Change in Carolinas Comfort Scale	Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.	24 Months
Change in SF(Short-form)-12	The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.	24 Months
Surgical Procedure Time as Measured From Incision to Closure	Surgical procedure time as measured from incision to closure (skin to skin)	During Procedure, up to 243 minutes
Length of Hospital Stay	Number of days admitted to the hospital for index surgery	1 month

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: William Hope, MD, New Hanover Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: DVL-HE-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No