A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

C. R. Bard

Status

Completed

Conditions

Incisional Hernia

Ventral Hernia

Treatments

Device: Resorbable Mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT01961687

DVL-HE-011

Details and patient eligibility

About

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

Full description

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have met all of the criteria listed below to be enrolled in the study:

Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions:
Body Mass Index (BMI) between 30-40 kg/m2, inclusive
Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)
COPD presence on patient self-report
Diabetes mellitus
Immunosuppression
Coronary Artery Disease
Chronic corticosteroid use: greater than 6 months systemic use
Serum albumin less than 3.4 g/dL
Advanced age: 75 years or older
Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

Exclusion criteria

Subjects were excluded from study enrollment if any of the following criteria were met:

Subject's hernia had recurred more than once (protocol version 1.4)
Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
The subject had peritonitis
The subject was on or suspected to be placed on chemotherapy medications during any part of the study
The subject's Body Mass Index (BMI) was greater than 40 kg/m2
The subject had cirrhosis of the liver and/or ascites
Subject was American Society of Anesthesiology Class 4 or 5
Subject was known to be infected with human immunodeficiency virus (HIV)
Subject had a life expectancy of less than 2 years at the time of enrollment
Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements
Subject's hernia repair utilized intraabdominal mesh placement
Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol)
Subject had an active or latent systemic infection
Subject required surgical bridge repair as the sole repair
Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding
Subject had enrolled in another clinical study within the last 30 days
Subject was part of the site personnel directly involved with this study
Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).