A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:

1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
2. Perioperative, short-term and long-term procedural and/or device related complications.
3. Abdominal Wall Function and mobility.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Phasix mesh implant

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patents with ventral hernias that meet eligibility criteria.

Description

Inclusion Criteria:

The subject must meet all of the relevant criteria listed below to be enrolled in the study:

1. Subject must be ≥18 years of age.
2. Subject or subject's legally authorized representative must be willing give written informed consent.
3. Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
4. Hernia size greater than 10cm2 and less than 250cm2
5. Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria:

The subject must be excluded from study enrollment if any of the following criteria are met:

1. Subject's hernia is multiply recurrent.
2. CDC wound classification other than clean or clean-contaminated
3. The use of surgical repair as a bridge.
4. Patient has a contraindication to placement of mesh.
5. Concomitant procedures with wound classification other than clean
6. Subject has peritonitis.
7. Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
8. Subject's body mass index (BMI) >55 kg/m2.
9. Subject has cirrhosis, and/or ascites.
10. Subject is American Society of Anesthesiology Class 4 or 5.
11. Subject is known to be infected with human immunodeficiency virus (HIV).
12. Subject has known allergies to tetracycline or kanamycin.
13. Subject has a life expectancy of less than 2 years at the time of enrollment.
14. Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phasix mesh; Mesh being used for approved use. Mesh for ventral and incisional hernias.	Device: Phasix mesh implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh	Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.	up to 24 months post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Component Summery	Quality of life survey- Short Form 12. Physical component summery. Assessment of physical limitations such as bathing, dressing, or physical activities. Scales range from 0-100. Low scores indicate someone with many limitations, while high scores indicate someone with no or few limitations.	baseline, 12 months, 24 months
Role Emotional Quality of Life Outcome	Quality of life survey- Short Form 12 Role emotional subdomain. This assesses if the patient experiences problems with work or other daily activities as a result of their emotional health. Scales range from 0-100. Low scores indicate the patient experiences many problems at work or with other daily activities as a result of poor emotional health. High scores indicate no problems with work or daily activities as a result of emotional health.	baseline, 12 months, 24 months
Physical Functioning Quality of Life Outcome	Quality of life survey- Short Form 12 Physical Functioning subdomain. Assesses ability to perform physical activities, including bathing and dressing one's self. Scales range from 0-100. Low scores indicate many limitations with physical activities. High scores indicate no problems with physical activities.	baseline, 12 months, 24 months
Role Physical Quality of Life Outcome	Quality of life survey- Short Form 12 Role physical subdomain. Assesses ability to perform physical activity such as bathing and dressing one's self. Scales range from 0-100. Low scores indicate problems with physical activities. High scores indicate no problems performing physical activities.	baseline, 12 months, 24 months
Bodily Pain Quality of Life Outcome	Quality of life survey- Short Form 12 Bodily Pain subdomain. Assesses level of bodily pain. scales range from 0-100. low scores indicate a severe level of pain that is limiting. High scores indicate a low level of pain or no pain-related limitations.	baseline, 12 months, 24 months
General Health Quality of Life Outcome	Quality of life survey- Short Form 12 General Health Subdomain. Assesses level of general health related to . Scales 0-100. low scores indicate poor general health, and high scores indicate good general health.	baseline, 12 months, 24 months
Mental Component Summery	Quality of life survey- Short Form 12 Mental Component Summery. Assesses level of mental health. Scales range from 0-100. Low scores indicate nervousness and depression. High scores indicate feeling peaceful, happy, and calm.	baseline, 12 months, 24 months
Vitality Quality of Life Outcome	Quality of life survey- Short Form 12 Vitality subdomain. Assesses level of energy. Scales range from 0-100. Low scores indicate low levels of energy, while high scores indicate high levels of energy.	baseline, 12 months, 24 months
Social Functioning Quality of Life Outcome	Quality of life survey- Short Form 12 Social Functioning subdomain. Assesses ability to participate in normal social activities without difficulties due to physical or emotional health problems. Scores are normalized to 0-100, with 50 being the national normalized mean. Lower scores indicate many difficulties with normal social activities due to physical or emotional health problems. Higher scores indicate little or no difficulties with normal social activities due to physical or emotional health problems.	baseline, 12 months, 24 months
Mental Health Quality of Life Outcome	Quality of life survey- Short Form 12 Mental Health subdomain. assesses level of mental health. Scale ranges from 0-100. Low scores indicate depression and nervousness. High scores indicate feeling peaceful, happy, and calm.	baseline, 12 months, 24 months
Abdominal Wall Mobility	Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively.	12 Months
Abdominal Wall Function	Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively	up to 12 months post surger

Collaborators and Investigators

• Sponsor: John Roth

Publications and helpful links

General Publications

• Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2013
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (ESTIMATE): May 27, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Resorbable mesh; Phasix mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: Phasix

Plan for Individual participant data (IPD)

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