Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

NCT02703662 | Unknown Phase 2

• 1 other identifier: Bio_ Mesh
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

Biologic mesh; abdominal wall reconstruction

Outcome Measures

Primary Outcomes (1)

• The percentage of hernia recurrence in patients received the biologic meshes.

  12 months postoperation

Secondary Outcomes (2)

• 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

Study Arms (2)

Strattice biologic mesh

ACTIVE COMPARATOR

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

Device: Strattice biologic mesh

Permacol biologic mesh

EXPERIMENTAL

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

Device: Permacol biologic mesh

Interventions

Strattice biologic mesh DEVICE

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

Strattice biologic mesh

Permacol biologic mesh DEVICE

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

Permacol biologic mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if they are unable or unwilling to provide informed consent.

Sponsors & Collaborators

• University of Calgary: lead
• Medtronic: collaborator

Study Sites (1)

Foothills Medical Centre, Faculty of Medicine

Calgary, Alberta, T2N2T9, Canada

RECRUITING

Related Publications (13)

• 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.

  PMID: 15383785 BACKGROUND

• 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.

  PMID: 23489939 BACKGROUND

• 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.

  PMID: 9565117 BACKGROUND

• 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.

  PMID: 23426340 BACKGROUND

• 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.

  PMID: 24496103 BACKGROUND

• 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.

  PMID: 24462172 BACKGROUND

• 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.

  PMID: 22444712 BACKGROUND

• 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.

  PMID: 23673399 BACKGROUND

• 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.

  PMID: 22867726 BACKGROUND

• 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.

  PMID: 22436406 BACKGROUND

• 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.

  PMID: 25264647 BACKGROUND

• 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.

  PMID: 25925149 BACKGROUND

• 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.

  PMID: 30772851 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 9, 2016
• Study Start: October 26, 2017
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)