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

NCT01961687 | Completed Results

• 1 other identifier: DVL-HE-011
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Ventral Hernia; Incisional Hernia

Outcome Measures

Primary Outcomes (2)

• Hernia Recurrence Rate

  Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

  60 Months

• Surgical Site Infections

  Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections

  60 Months

Secondary Outcomes (7)

• Pain Visual Analog Scale

  60 Months

• Device Related Adverse Events

  60 Months

• Rate of Re-operation Due to the Index Hernia Repair

  60 Months

• Carolinas Comfort Scale® (CCS)

  60 Months

• SF-12 Questionnaire

  60 Months

Study Arms (1)

Resorbable Mesh

OTHER

Phasix Mesh

Device: Resorbable Mesh

Interventions

Resorbable Mesh DEVICE

Phasix Mesh

Resorbable Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (16)

University of California, San Diego

San Diego, California, 92103, United States

Location

Florida Hospital/Celebration Health

Celebration, Florida, 34747, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40506, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Worcester

Worcester, Massachusetts, 01655, United States

Location

Methodist Health System

Omaha, Nebraska, 68114, United States

Location

Southeast Area Health and Education Center

Wilmington, North Carolina, 28403, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Univerity of Tennessee Health Science Center

Germantown, Tennessee, 38163, United States

Location

University of Tennessee Health Sciences Center

Knoxville, Tennessee, 37996, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

University of Wisconsin System

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 36102523 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Limitations and Caveats

The study was designed as a single arm observational trial without pre-defined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment or conclusions can be made.

Results Point of Contact

• Title: Dawn Heimer / Sr. Director Medical Affairs
• Organization: Becton Dickinson

dawn.heimer@bd.com

401-479-1253

Study Officials

• Scott Roth, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 11, 2013
• Study Start: September 1, 2013
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)