Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction
Primary Purpose
Ventral Hernia
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Strattice biologic mesh
Permacol biologic mesh
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring Biologic mesh, abdominal wall reconstruction
Eligibility Criteria
Inclusion Criteria:
- The study population will consist of adult patients, 18 years or older, undergoing an abdominal wall reconstruction. Prior to selection, at least 2 surgeons involved in the trial must agree that the indication for use of biologic implant is mutual.
Exclusion Criteria:
- Patients will be excluded if they are unable or unwilling to provide informed consent.
Sites / Locations
- Foothills Medical Centre, Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Strattice biologic mesh
Permacol biologic mesh
Arm Description
Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Outcomes
Primary Outcome Measures
The percentage of hernia recurrence in patients received the biologic meshes.
Secondary Outcome Measures
The percentage of wound infection of the participants.
The days of hospital stay post the abdominal wall reconstruction procedure.
Full Information
NCT ID
NCT02703662
First Posted
February 25, 2016
Last Updated
February 1, 2023
Sponsor
University of Calgary
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02703662
Brief Title
Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction
Official Title
Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Medtronic
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
No
5. Study Description
Brief Summary
To date, there have been no prospective randomized controlled trials that compare various biologic mesh materials in the context of abdominal wall reconstruction. As a result, this proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a randomized manner. Although there are significant differences between these mesh products with regard to procurement, tissue processing and cost, clinical controlled trials are needed to compare their performance.
Detailed Description
Complex abdominal wall reconstructions utilize advanced techniques that include, but are not limited to, component separation, modified component separation, and free tissue flap reconstruction. Data suggests that recurrence rates are lowered with the insertion of mesh supporting materials. More specifically, synthetic mesh utilization during repair of simple clean ventral hernias reduces hernia recurrence by over 50% when compared to suture closure alone. Unfortunately in the presence of microbial contamination or infection, there is a marked increase in hernia recurrence and mesh infection using synthetic prostheses. Biologic meshes however are established options for use in abdominal wall reconstruction in the presence of both field contamination and infection. These indications, as well as others, for biologic materials include, but are not limited to, patients with chronic immunosuppression, infected fields, colonized fields (i.e. preceding synthetic mesh), the need to place the product within the peritoneal cavity (underlay), and patients with complex losses of domain. It should also be noted that there may be significant utility in their use of biologic materials in a much broader range of indications, but the economic cost of these products have clearly tempored wider indications for overall use.
To date, there have been no prospective randomized controlled trials that compare various biologic mesh materials in the context of abdominal wall reconstruction. As a result, this proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a randomized manner. Although there are significant differences between these mesh products with regard to procurement, tissue processing and cost, clinical controlled trials are needed to compare their performance.
Given the nearly 2-fold difference in cost between the 2 included biologic meshes, equivalence with regard to recurrence and postoperative complications would represent a massive economic savings to the public health care system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Biologic mesh, abdominal wall reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Strattice biologic mesh
Arm Type
Active Comparator
Arm Description
Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Arm Title
Permacol biologic mesh
Arm Type
Experimental
Arm Description
Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Intervention Type
Device
Intervention Name(s)
Strattice biologic mesh
Intervention Description
Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.
Intervention Type
Device
Intervention Name(s)
Permacol biologic mesh
Intervention Description
Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.
Primary Outcome Measure Information:
Title
The percentage of hernia recurrence in patients received the biologic meshes.
Time Frame
12 months postoperation
Secondary Outcome Measure Information:
Title
The percentage of wound infection of the participants.
Time Frame
12 months postoperation
Title
The days of hospital stay post the abdominal wall reconstruction procedure.
Time Frame
12 months postoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The study population will consist of adult patients, 18 years or older, undergoing an abdominal wall reconstruction. Prior to selection, at least 2 surgeons involved in the trial must agree that the indication for use of biologic implant is mutual.
Exclusion Criteria:
Patients will be excluded if they are unable or unwilling to provide informed consent.
Facility Information:
Facility Name
Foothills Medical Centre, Faculty of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad G Ball, MD
Phone
403-944-3417
Email
ball.chad@gmail.com
First Name & Middle Initial & Last Name & Degree
Jimmy Xiao, PhD
Phone
403-944-8750
Email
jimmy.xiao@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Chad G Ball, MD
First Name & Middle Initial & Last Name & Degree
Jimmy Xiao, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15383785
Citation
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Results Reference
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PubMed Identifier
23489939
Citation
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Results Reference
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Citation
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Citation
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Citation
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Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction
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