Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction - A Randomized Controlled Trial

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Strattice biologic mesh
* Device: Permacol biologic mesh


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strattice biologic mesh<br>Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction. | Device: Strattice biologic mesh<br>* Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.<br>|
| Experimental: Permacol biologic mesh<br>Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction. | Device: Permacol biologic mesh<br>* Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of hernia recurrence in patients received the biologic meshes. |  | 12 months postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of wound infection of the participants. |  | 12 months postoperation | 
| The days of hospital stay post the abdominal wall reconstruction procedure. |  | 12 months postoperation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biologic mesh, abdominal wall reconstruction