Clinical trial NCT01863030: A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Official title: A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: Resorbable mesh
Phasix mesh
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patents with ventral hernias that meet eligibility criteria.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
timeFrame: up to 24 months post surgery
Secondary outcomes:
Other outcomes:
measure: Physical Component Summery
timeFrame: baseline, 12 months, 24 months
measure: Role Emotional Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Physical Functioning Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Role Physical Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Bodily Pain Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: General Health Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Mental Component Summery
timeFrame: baseline, 12 months, 24 months
measure: Vitality Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Social Functioning Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Mental Health Quality of Life Outcome
timeFrame: baseline, 12 months, 24 months
measure: Abdominal Wall Mobility
timeFrame: 12 Months
measure: Abdominal Wall Function
timeFrame: up to 12 months post surger
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: John S Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.