Overview

This trial is active, not recruiting.

Conditions ventral hernia, incisional hernia
Treatment resorbable mesh
Sponsor C. R. Bard
Collaborator FGK Clinical Research GmbH
Start date September 2013
End date March 2018
Trial size 120 participants
Trial identifier NCT01961687, DVL-HE-011

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Phasix Mesh
resorbable mesh
Phasix Mesh

Primary Outcomes

Measure
Hernia Recurrence Rate
time frame: 36 Months
Surgical Site Infections
time frame: 36 Months

Secondary Outcomes

Measure
Pain VAS
time frame: 36 Months
Device related adverse event incidence
time frame: 36 Months
Rate of reoperation due to the index hernia repair
time frame: 36 Months
Carolinas Comfort Scale
time frame: 36 Months
SF-12 Questionnaire
time frame: 36 Months
Surgical procedure time as measured from incision to closure
time frame: 36 Months
Length of hospital stay
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Subjects must have met all of the criteria listed below to be enrolled in the study: 1. 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: 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: Subjects were excluded from study enrollment if any of the following criteria were met: 1. Subject's hernia had recurred more than once (protocol version 1.4) 1. Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0) 2. The subject had peritonitis 3. The subject was on or suspected to be placed on chemotherapy medications during any part of the study 4. The subject's Body Mass Index (BMI) was greater than 40 kg/m2 5. The subject had cirrhosis of the liver and/or ascites 6. Subject was American Society of Anesthesiology Class 4 or 5 7. Subject was known to be infected with human immunodeficiency virus (HIV) 8. Subject had a life expectancy of less than 2 years at the time of enrollment 9. 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 10. Subject's hernia repair utilized intraabdominal mesh placement 11. 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) 12. Subject had an active or latent systemic infection 13. Subject required surgical bridge repair as the sole repair 14. Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding 15. Subject had enrolled in another clinical study within the last 30 days 16. Subject was part of the site personnel directly involved with this study 17. Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).

Additional Information

Official title A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Principal investigator Scott Roth, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.