Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02703662
• Other study ID #: Bio_ Mesh
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 26, 2017
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Foothills Medical Centre, Faculty of Medicine	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Medtronic

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of hernia recurrence in patients received the biologic meshes.		12 months postoperation
Secondary	The percentage of wound infection of the participants.		12 months postoperation
Secondary	The days of hospital stay post the abdominal wall reconstruction procedure.		12 months postoperation