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

Incisional Hernia Clinical Trial

— ATLAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712398
• Other study ID #: DVL-HE-017
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 15, 2019

Study information

• Verified date: December 2020
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Device-related Adverse Event Incidence	Proportion of subjects with Investigator-determined device-related adverse events	24 Months
Secondary	Rate of Reoperation Due to Index Hernia Repair	Rate of reoperation due to the index hernia repair	24 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Hospital Stay	Number of days admitted to the hospital for index surgery	1 month