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

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.

I'M INTERESTED

This research study is led by Dr. John Romanelli.

Contact: Nicole Corriveau, 413-794-2367

Participation details:

September 01, 2013
BH13-260
Surgery
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Inclusion Criteria:

  • Subject must be 18 years of age or older
  • Subject or subject's legally authorized representative must have given written informed consent
  • Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4)
  • Subjects must have had 1 or more of the following pre-study conditions:
    1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive
    2. 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)
    3. COPD presence on patient self-report
    4. Diabetes mellitus
    5. Immunosuppression
    6. Coronary Artery Disease
    7. Chronic corticosteroid use: greater than 6 months systemic use
    8. Serum albumin less than 3.4 g/dL
    9. Advanced age: 75 years or older
    10. Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

Exclusion Criteria:

  • 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
Active
Interventional (Clinical Trial), Single Group Assignment