NCT02712398

Brief Summary

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

March 15, 2016

Results QC Date

November 16, 2020

Last Update Submit

December 14, 2020

Conditions

Hernia, VentralIncisional Hernia

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Occurrence Rate

    Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.

    45 Days

Secondary Outcomes (9)

  • Surgical Site Occurrence Rate

    3 months

  • Hernia Recurrence Rate

    24 Months

  • Pain Visual Analog Scale

    24 Months

  • Device-related Adverse Event Incidence

    24 Months

  • Rate of Reoperation Due to Index Hernia Repair

    24 Months

  • +4 more secondary outcomes

Study Arms (1)

Phasix™ ST

EXPERIMENTAL

Subjects treated with Phasix™ ST mesh

Device: Phasix™ ST

Interventions

Phasix™ STDEVICE

Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.

Phasix™ ST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be 18 years of age or older
  • Subject must be willing to give written informed consent
  • Subject must be diagnosed with ventral or abdominal incisional hernia
  • Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
  • Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
  • Subject is expected to meet the criteria for a Class I wound
  • Subjects must have 1 or more of the following pre-study conditions:
  • Body Mass Index (BMI) between 30-40 kg/m2, inclusive
  • Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery)
  • COPD presence on patient self-report
  • Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
  • Immunosuppression
  • Coronary Artery Disease
  • Chronic corticosteroid use: greater than 6 months systemic use
  • Serum albumin less than 3.4 g/dL
  • +2 more criteria

You may not qualify if:

  • Subject has had 4 or more previous hernia repairs (of the index hernia)
  • Subject's hernia is \> 350 cm2
  • Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
  • Subject has intact permanent mesh adjacent to the current hernia to be repaired
  • Preperitoneal placement of mesh
  • The subject is known to have a collagen disorder
  • The subject has peritonitis
  • The subject is on or suspected to be placed on chemotherapy medications during any part of the study
  • The subject's Body Mass Index (BMI) is \> 40 kg/m2
  • The subject has cirrhosis of the liver and/or ascites
  • Subject is American Society of Anesthesiology Class 4 or 5
  • Subject has a life expectancy of less than 2 years at the time of enrollment
  • Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
  • Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated)
  • Subject has an active or latent systemic infection
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Yale-New Haven Medical Center

New Haven, Connecticut, 06510, United States

Location

Florida Hospital

Celebration, Florida, 34747, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Via-Christi Hospital

Wichita, Kansas, 67214, United States

Location

Georgetown Community Hospital

Georgetown, Kentucky, 40324, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Legacy Emanuel Hospital

Portland, Oregon, 97210, United States

Location

Hershey Penn State Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

Overlake Hospital

Bellevue, Washington, 98004, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic 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 comparisons 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

  • William Hope, MD

    New Hanover Regional Medical Center

    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
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

April 1, 2016

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

January 8, 2021

Results First Posted

January 8, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(16)