A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Not Applicable

Completed

Conditions: Incisional Hernia
Ventral Hernia

Interventions: Device: Resorbable Mesh

Registration Number: NCT02053168

Lead Sponsor: C. R. Bard

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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/m2.
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 5.
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).
Subject has a life expectancy of less than 2 years at the time of enrollment.
Subject has been treated with an investigational product in the past 30 days.
Subject is part of the site personnel directly involved with this study
Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resorbable Mesh	Resorbable Mesh	Phasix Mesh

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hernia Recurrence	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 Outcome Measures

Name	Time	Method
Surgical Procedure Time	Duration of index procedure (mean of 242.5 mins)	Measured from incision to closure (skin to skin).
Number of Study Related Post Operative Surgical Procedures	24 Months
Number of Participants With Device Related Adverse Events	24 Months	In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)	Baseline and 24 months postoperative	Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.
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	The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.
Number of Related Post-operative Visits Unrelated to Standard of Care	24 Months
Incidence of Seroma	24 Months
Length of Hospital Stay	10 Months	Measured from end of index procedure to hospital discharge
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)	Baseline and 24 months postoperative	Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.

Trial Locations

Locations (6): Florida Hospital Celebration Health
🇺🇸
Celebration, Florida, United States
Oregon Health and Sciences University
🇺🇸
Portland, Oregon, United States
Methodist Physicians Clinic
🇺🇸
Omaha, Nebraska, United States
Beverly Hills Hernia Center
🇺🇸
Beverly Hills, California, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States