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Trial record 3 of 3 for:    23673399 [PUBMED-IDS]

Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

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ClinicalTrials.gov Identifier: NCT02703662
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Device: Strattice biologic mesh Device: Permacol biologic mesh Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction - A Randomized Controlled Trial
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Strattice biologic mesh
Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Device: Strattice biologic mesh
Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.

Experimental: Permacol biologic mesh
Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Device: Permacol biologic mesh
Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.




Primary Outcome Measures :
  1. The percentage of hernia recurrence in patients received the biologic meshes. [ Time Frame: 12 months postoperation ]

Secondary Outcome Measures :
  1. The percentage of wound infection of the participants. [ Time Frame: 12 months postoperation ]
  2. The days of hospital stay post the abdominal wall reconstruction procedure. [ Time Frame: 12 months postoperation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703662


Locations
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Canada, Alberta
Foothills Medical Centre, Faculty of Medicine Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Chad G Ball, MD    403-944-3417    ball.chad@gmail.com   
Contact: Jimmy Xiao, PhD    403-944-8750    jimmy.xiao@albertahealthservices.ca   
Principal Investigator: Chad G Ball, MD         
Sub-Investigator: Jimmy Xiao, PhD         
Sponsors and Collaborators
University of Calgary
Medtronic

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chad G. Ball, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02703662     History of Changes
Other Study ID Numbers: Bio_ Mesh
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dr. Chad G. Ball, University of Calgary:
Biologic mesh
abdominal wall reconstruction
Additional relevant MeSH terms:
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Hernia, Ventral
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal