Clinical trial NCT01961687: A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Official title: A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Incisional Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2013-10-11
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Hernia Recurrence Rate
timeFrame: 60 Months
measure: Surgical Site Infections
timeFrame: 60 Months
Secondary outcomes:
measure: Pain Visual Analog Scale
timeFrame: 60 Months
measure: Device Related Adverse Events
timeFrame: 60 Months
measure: Rate of Re-operation Due to the Index Hernia Repair
timeFrame: 60 Months
measure: Carolinas Comfort Scale® (CCS)
timeFrame: 60 Months
measure: SF-12 Questionnaire
timeFrame: 60 Months
measure: Surgical Procedure Time as Measured From Incision to Closure
timeFrame: 1 day
measure: Length of Hospital Stay
timeFrame: 35 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Celebration
country: United States
facility: Florida Hospital/Celebration Health
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Omaha
country: United States
facility: Methodist Health System
state: Nebraska
city: Wilmington
country: United States
facility: Southeast Area Health and Education Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Germantown
country: United States
facility: Univerity of Tennessee Health Science Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin System
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Kentucky
name: Scott Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Badhwar A, Salluzzo JL, Voeller GR. Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. J Am Coll Surg. 2022 Dec 1;235(6):894-904. doi: 10.1097/XCS.0000000000000363. Epub 2022 Nov 15.