Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

NCT ID: NCT02703662

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-26
• Study Completion Date: 2025-12-31

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Strattice biologic mesh

Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.

Group Type: ACTIVE_COMPARATOR

Strattice biologic mesh

Intervention Type: DEVICE

Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.

Permacol biologic mesh

Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.

Group Type: EXPERIMENTAL

Permacol biologic mesh

Intervention Type: DEVICE

Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.

Interventions

Strattice biologic mesh

Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chad G. Ball

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Foothills Medical Centre, Faculty of Medicine

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Chad G Ball, MD

Role: primary

ball.chad@gmail.com

403-944-3417

Jimmy Xiao, PhD

Role: backup

jimmy.xiao@albertahealthservices.ca

403-944-8750

References

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Reference Type: BACKGROUND

PMID: 15383785 (View on PubMed)

Richmond BK, Chong B. Routine use of bioprosthetic mesh is not necessary: a retrospective review of 100 consecutive cases of intra-abdominal midweight polypropylene mesh for ventral hernia repair. Surgery. 2013 May;153(5):741. doi: 10.1016/j.surg.2013.02.006. Epub 2013 Mar 13. No abstract available.

Reference Type: BACKGROUND

PMID: 23489939 (View on PubMed)

Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998 Apr;133(4):378-82. doi: 10.1001/archsurg.133.4.378.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23426340 (View on PubMed)

Lupinacci RM, Gizard AS, Rivkine E, Debove C, Menegaux F, Barrat C, Wind P, Tresallet C. Use of a bioprosthetic mesh in complex hernia repair: early results from a French multicenter pilot study. Surg Innov. 2014 Dec;21(6):600-4. doi: 10.1177/1553350613520514. Epub 2014 Feb 3.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23673399 (View on PubMed)

Bellows CF, Smith A, Malsbury J, Helton WS. Repair of incisional hernias with biological prosthesis: a systematic review of current evidence. Am J Surg. 2013 Jan;205(1):85-101. doi: 10.1016/j.amjsurg.2012.02.019. Epub 2012 Aug 4.

Reference Type: BACKGROUND

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Smart NJ, Marshall M, Daniels IR. Biological meshes: a review of their use in abdominal wall hernia repairs. Surgeon. 2012 Jun;10(3):159-71. doi: 10.1016/j.surge.2012.02.006. Epub 2012 Mar 20.

Reference Type: BACKGROUND

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Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. Am Surg. 2014 Oct;80(10):999-1002.

Reference Type: BACKGROUND

PMID: 25264647 (View on PubMed)

Melnik I, Goldstein D, Yoffe B. Use of a porcine dermal collagen implant for contaminated abdominal wall reconstruction in a 105-year-old woman: a case report and review of the literature. J Med Case Rep. 2015 Apr 29;9:95. doi: 10.1186/s13256-015-0569-9.

Reference Type: BACKGROUND

PMID: 25925149 (View on PubMed)

Carver DA, Kirkpatrick AW, Eberle TL, Ball CG. Performance of biological mesh materials in abdominal wall reconstruction: study protocol for a randomised controlled trial. BMJ Open. 2019 Feb 15;9(2):e024091. doi: 10.1136/bmjopen-2018-024091.

Reference Type: DERIVED

PMID: 30772851 (View on PubMed)

Other Identifiers

Bio_ Mesh

Identifier Type: -

Identifier Source: org_study_id