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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053168
• Other study ID #: DVL-HE-015
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 23, 2017

Study information

• Verified date: April 2018
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Pilot Study of patients across all wound classes for recurrence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Resorbable Mesh
Phasix Mesh

Locations

Country	Name	City	State
United States	Beverly Hills Hernia Center	Beverly Hills	California
United States	Florida Hospital Celebration Health	Celebration	Florida
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Methodist Physicians Clinic	Omaha	Nebraska
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hernia Recurrence	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.	1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
Secondary	Number of Participants With Device Related Adverse Events	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.	24 Months
Secondary	Carolinas Comfort Scale (CCS) Total Score - Change From Baseline	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.	Baseline and 24 months postoperative
Secondary	Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)	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.	Baseline and 24 months postoperative
Secondary	Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)	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.	Baseline and 24 months postoperative
Secondary	Surgical Procedure Time	Measured from incision to closure (skin to skin).	Duration of index procedure (mean of 242.5 mins)
Secondary	Length of Hospital Stay	Measured from end of index procedure to hospital discharge	10 Months
Secondary	Number of Study Related Post Operative Surgical Procedures		24 Months
Secondary	Number of Study Related Post Operative New Hospital Admissions		24 Months
Secondary	Number of Related Post-operative Visits Unrelated to Standard of Care		24 Months
Secondary	Incidence of Seroma		24 Months