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Phasix Mesh Use in Complex Open Ventral Hernias Study

Primary Purpose

Ventral Hernia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repair of ventral hernia using biologic mesh
Repair of ventral hernia using suture repair or synthetic mesh
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria:

  • Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
  • Unlikely to follow-up (live out of state, unable to be reached by phone or email)
  • Non-English and non-Spanish speakers
  • Pregnant or breast-feeding patients
  • Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate

Sites / Locations

  • Lyndon B. Johnson General Hospital
  • Memorial Hermann Hospital-Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phasix Mesh

Current Care

Arm Description

Phasix mesh will be used in the repair of the hernia

The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.

Outcomes

Primary Outcome Measures

Major complication free
A composite of hernia recurrence, reoperation, chronic wound complication, or death

Secondary Outcome Measures

Surgical site occurrences
Surgical site infection, seroma, hematoma, and skin dehiscence
Clavien-Dindo complication grade
Clavien-Dindo complication grade
Hospital duration
Days in hospital composed of post-operative length of stay and readmissions
Emergency room visits
Number of times ER was visited
Cost Analysis
Analysis of costs as performed from the healthcare perspective
Post-operative abdominal pain
Measured by the visual analogue scale (VAS)
Patient centered outcomes
Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)

Full Information

First Posted
October 2, 2020
Last Updated
June 20, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04580524
Brief Title
Phasix Mesh Use in Complex Open Ventral Hernias Study
Official Title
Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to secure funding
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phasix Mesh
Arm Type
Active Comparator
Arm Description
Phasix mesh will be used in the repair of the hernia
Arm Title
Current Care
Arm Type
Active Comparator
Arm Description
The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.
Intervention Type
Procedure
Intervention Name(s)
Repair of ventral hernia using biologic mesh
Intervention Description
Ventral hernia will be repaired using biologic mesh
Intervention Type
Procedure
Intervention Name(s)
Repair of ventral hernia using suture repair or synthetic mesh
Intervention Description
Ventral hernia will be repaired using the current treatment methods
Primary Outcome Measure Information:
Title
Major complication free
Description
A composite of hernia recurrence, reoperation, chronic wound complication, or death
Time Frame
2 years post-operative
Secondary Outcome Measure Information:
Title
Surgical site occurrences
Description
Surgical site infection, seroma, hematoma, and skin dehiscence
Time Frame
90 days post-operative
Title
Clavien-Dindo complication grade
Description
Clavien-Dindo complication grade
Time Frame
90 days post-operative
Title
Hospital duration
Description
Days in hospital composed of post-operative length of stay and readmissions
Time Frame
90 days post-operative
Title
Emergency room visits
Description
Number of times ER was visited
Time Frame
90 days post-operative
Title
Cost Analysis
Description
Analysis of costs as performed from the healthcare perspective
Time Frame
2 years
Title
Post-operative abdominal pain
Description
Measured by the visual analogue scale (VAS)
Time Frame
Day of consent and post-operatively at 1 month, 1 year and 2 years
Title
Patient centered outcomes
Description
Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)
Time Frame
Day of consent and post-operatively at 1 month, 1 year and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years or older) with a complex ventral hernia scheduled for repair Exclusion Criteria: Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement) Unlikely to follow-up (live out of state, unable to be reached by phone or email) Non-English and non-Spanish speakers Pregnant or breast-feeding patients Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Holihan, MD
Organizational Affiliation
UTHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Memorial Hermann Hospital-Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phasix Mesh Use in Complex Open Ventral Hernias Study

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