Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

• ClinicalTrials.gov Identifier: NCT02703662
• Recruitment Status: Recruiting
• First Posted: March 9, 2016
• Last Update Posted: February 3, 2023
• Sponsor: University of Calgary
• Collaborator: Medtronic
• Information provided by (Responsible Party): Dr. Chad G. Ball, University of Calgary

Tracking Information

• First Submitted Date: February 25, 2016
• First Posted Date: March 9, 2016
• Last Update Posted Date: February 3, 2023
• Actual Study Start Date: October 26, 2017
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 8, 2016): The percentage of hernia recurrence in patients received the biologic meshes. [ Time Frame: 12 months postoperation ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ventral Hernia

Intervention

• 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.
• 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.

Study Arms

• Active Comparator: Strattice biologic mesh
  Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
  Intervention: Device: Strattice biologic mesh
• Experimental: Permacol biologic mesh
  Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
  Intervention: Device: Permacol biologic mesh

Publications *

• Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7.
• 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.
• 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.
• Rosen MJ, Krpata DM, Ermlich B, Blatnik JA. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013 Jun;257(6):991-6. doi: 10.1097/SLA.0b013e3182849871.
• 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.
• Iacco A, Adeyemo A, Riggs T, Janczyk R. Single institutional experience using biological mesh for abdominal wall reconstruction. Am J Surg. 2014 Sep;208(3):480-4; discussion 483-4. doi: 10.1016/j.amjsurg.2013.09.020. Epub 2013 Dec 25.
• Ouellet JF, Ball CG, Kortbeek JB, Mack LA, Kirkpatrick AW. Bioprosthetic mesh use for the problematic thoracoabdominal wall: outcomes in relation to contamination and infection. Am J Surg. 2012 May;203(5):594-597. doi: 10.1016/j.amjsurg.2012.01.008. Epub 2012 Mar 23.
• Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 8, 2016): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02703662
• Other Study ID Numbers: Bio_ Mesh
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Chad G. Ball, University of Calgary
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Calgary
• Original Study Sponsor: Same as current
• Collaborators: Medtronic
• Investigators: Not Provided
• PRS Account: University of Calgary
• Verification Date: February 2023