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

NCT ID: NCT01961687

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2020-01-27

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.

Conditions

Ventral Hernia; Incisional Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Resorbable Mesh

Phasix Mesh

Group Type: OTHER

Resorbable Mesh

Intervention Type: DEVICE

Phasix Mesh

Interventions

Resorbable Mesh

Phasix Mesh

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FGK Clinical Research GmbH

INDUSTRY

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Roth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of California, San Diego

San Diego, California, United States

Florida Hospital/Celebration Health

Celebration, Florida, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Massachusetts Worcester

Worcester, Massachusetts, United States

Methodist Health System

Omaha, Nebraska, United States

Southeast Area Health and Education Center

Wilmington, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Univerity of Tennessee Health Science Center

Germantown, Tennessee, United States

University of Tennessee Health Sciences Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Wisconsin System

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36102523 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DVL-HE-011

Identifier Type: -

Identifier Source: org_study_id