A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair

C. R. Bard6 sites in 1 country33 target enrollmentFebruary 2014

ConditionsVentral Hernia Incisional Hernia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventral Hernia
Sponsor: C. R. Bard
Enrollment: 33
Locations: 6
Primary Endpoint: Number of Participants With Hernia Recurrence
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Detailed Description

Pilot Study of patients across all wound classes for recurrence

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

February 23, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject or subject's legally authorized representative must be willing to give written informed consent
•Subject must be diagnosed with ventral or incisional hernia
•Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria

•Subject is an active smoker (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).
•Subject's hernia has recurred four or more times.
•Subject's body mass index (BMI) \>40 kg/m
•Subject has peritonitis.
•Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
•Chronic steroid use or immunosuppression drugs (\> 6 months).
•Subject has cirrhosis, and/or ascites.
•Subject is American Society of Anesthesiology Class 4 or
•Subject is pregnant or planning to become pregnant during the course of the study.
•Subject is known to be infected with human immunodeficiency virus (HIV).

Outcomes

Primary Outcomes

Number of Participants With Hernia Recurrence

Time Frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months

A recurrent hernia was 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. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

Secondary Outcomes

Surgical Procedure Time(Duration of index procedure (mean of 242.5 mins))
Number of Study Related Post Operative Surgical Procedures(24 Months)
Number of Participants With Device Related Adverse Events(24 Months)
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)(Baseline and 24 months postoperative)
Number of Study Related Post Operative New Hospital Admissions(24 Months)
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline(Baseline and 24 months postoperative)
Number of Related Post-operative Visits Unrelated to Standard of Care(24 Months)
Incidence of Seroma(24 Months)
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)(Baseline and 24 months postoperative)
Length of Hospital Stay(10 Months)