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

Completed

• Conditions: Ventral Hernia
• Interventions: Device: Phasix mesh implant

• Registration Number: NCT01863030
• Lead Sponsor: John Roth

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-07-04
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-21
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phasix mesh	Phasix mesh implant	Mesh being used for approved use. Mesh for ventral and incisional hernias.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States