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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863030
• Other study ID #: Phasix
• Status: Completed
• Start date: May 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Device:
• Phasix mesh implant

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
John Roth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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