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Published in: Surgical Endoscopy 9/2016

Open Access 01-09-2016

Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair

Authors: Jeffrey R. Scott, Corey R. Deeken, Robert G. Martindale, Michael J. Rosen

Published in: Surgical Endoscopy | Issue 9/2016

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Abstract

Background

The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair.

Methods

Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point).

Results

Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal–mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal–mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling.

Conclusions

Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.
Literature
1.
go back to reference Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD (2012) Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 16:179–183CrossRefPubMed Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD (2012) Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 16:179–183CrossRefPubMed
2.
3.
go back to reference Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 240:578–583PubMedPubMedCentral Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 240:578–583PubMedPubMedCentral
4.
go back to reference Luijendijk RW, Hop WC, Van Den Tol MP, De Lange DC, Braaksma MM, Ijzermans JN, Boelhouwer RU, De Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392–398CrossRefPubMed Luijendijk RW, Hop WC, Van Den Tol MP, De Lange DC, Braaksma MM, Ijzermans JN, Boelhouwer RU, De Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392–398CrossRefPubMed
5.
go back to reference Klinge U, Klosterhalfen B, Muller M, Schumpelick V (1999) Foreign body reaction to meshes used for the repair of abdominal wall hernias. Eur J Surg 165:665–673CrossRefPubMed Klinge U, Klosterhalfen B, Muller M, Schumpelick V (1999) Foreign body reaction to meshes used for the repair of abdominal wall hernias. Eur J Surg 165:665–673CrossRefPubMed
6.
go back to reference Klosterhalfen B, Junge K, Hermanns B, Klinge U (2002) Influence of implantation interval on the long-term biocompatibility of surgical mesh. Br J Surg 89:1043–1048CrossRefPubMed Klosterhalfen B, Junge K, Hermanns B, Klinge U (2002) Influence of implantation interval on the long-term biocompatibility of surgical mesh. Br J Surg 89:1043–1048CrossRefPubMed
7.
go back to reference Klosterhalfen B, Klinge U (2013) Retrieval study at 623 human mesh explants made of polypropylene - impact of mesh class and indication for mesh removal on tissue reaction. J Biomed Mater Res B Appl Biomater 101:1393–1399CrossRefPubMed Klosterhalfen B, Klinge U (2013) Retrieval study at 623 human mesh explants made of polypropylene - impact of mesh class and indication for mesh removal on tissue reaction. J Biomed Mater Res B Appl Biomater 101:1393–1399CrossRefPubMed
8.
go back to reference Carbonell AM, Matthews BD, Dreau D, Foster M, Austin CE, Kercher KW, Sing RF, Heniford BT (2005) The susceptibility of prosthetic biomaterials to infection. Surg Endosc 19:430–435CrossRefPubMed Carbonell AM, Matthews BD, Dreau D, Foster M, Austin CE, Kercher KW, Sing RF, Heniford BT (2005) The susceptibility of prosthetic biomaterials to infection. Surg Endosc 19:430–435CrossRefPubMed
9.
go back to reference Demirer S, Gecim IE, Aydinuraz K, Ataoglu H, Yerdel MA, Kuterdem E (2001) Affinity of Staphylococcus epidermidis to various prosthetic graft materials. J Surg Res 99:70–74CrossRefPubMed Demirer S, Gecim IE, Aydinuraz K, Ataoglu H, Yerdel MA, Kuterdem E (2001) Affinity of Staphylococcus epidermidis to various prosthetic graft materials. J Surg Res 99:70–74CrossRefPubMed
10.
go back to reference Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen MJ (2010) Novel in vitro model for assessing susceptibility of synthetic hernia repair meshes to Staphylococcus aureus infection using green fluorescent protein-labeled bacteria and modern imaging techniques. Surg Infect (Larchmt) 11:449–454CrossRef Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen MJ (2010) Novel in vitro model for assessing susceptibility of synthetic hernia repair meshes to Staphylococcus aureus infection using green fluorescent protein-labeled bacteria and modern imaging techniques. Surg Infect (Larchmt) 11:449–454CrossRef
11.
go back to reference Engelsman AF, Van Der Mei HC, Busscher HJ, Ploeg RJ (2008) Morphological aspects of surgical meshes as a risk factor for bacterial colonization. Br J Surg 95:1051–1059CrossRefPubMed Engelsman AF, Van Der Mei HC, Busscher HJ, Ploeg RJ (2008) Morphological aspects of surgical meshes as a risk factor for bacterial colonization. Br J Surg 95:1051–1059CrossRefPubMed
12.
go back to reference Blatnik JA, Krpata DM, Jacobs MR, Gao Y, Novitsky YW, Rosen MJ (2012) In vivo analysis of the morphologic characteristics of synthetic mesh to resist MRSA adherence. J Gastrointest Surg 16:2139–2144CrossRefPubMed Blatnik JA, Krpata DM, Jacobs MR, Gao Y, Novitsky YW, Rosen MJ (2012) In vivo analysis of the morphologic characteristics of synthetic mesh to resist MRSA adherence. J Gastrointest Surg 16:2139–2144CrossRefPubMed
13.
go back to reference Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V (2002) Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model. J Biomed Mater Res 63:765–771CrossRefPubMed Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V (2002) Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model. J Biomed Mater Res 63:765–771CrossRefPubMed
14.
go back to reference Harrell AG, Novitsky YW, Kercher KW, Foster M, Burns JM, Kuwada TS, Heniford BT (2006) In vitro infectability of prosthetic mesh by methicillin-resistant Staphylococcus aureus. Hernia 10:120–124CrossRefPubMed Harrell AG, Novitsky YW, Kercher KW, Foster M, Burns JM, Kuwada TS, Heniford BT (2006) In vitro infectability of prosthetic mesh by methicillin-resistant Staphylococcus aureus. Hernia 10:120–124CrossRefPubMed
15.
go back to reference Aydinuraz K, Agalar C, Agalar F, Ceken S, Duruyurek N, Vural T (2009) In vitro S. epidermidis and S. aureus adherence to composite and lightweight polypropylene grafts. J Surg Res 157:e79–e86CrossRefPubMed Aydinuraz K, Agalar C, Agalar F, Ceken S, Duruyurek N, Vural T (2009) In vitro S. epidermidis and S. aureus adherence to composite and lightweight polypropylene grafts. J Surg Res 157:e79–e86CrossRefPubMed
16.
go back to reference Harth KC, Broome AM, Jacobs MR, Blatnik JA, Zeinali F, Bajaksouzian S, Rosen MJ (2011) Bacterial clearance of biologic grafts used in hernia repair: an experimental study. Surg Endosc 25:2224–2229CrossRefPubMedPubMedCentral Harth KC, Broome AM, Jacobs MR, Blatnik JA, Zeinali F, Bajaksouzian S, Rosen MJ (2011) Bacterial clearance of biologic grafts used in hernia repair: an experimental study. Surg Endosc 25:2224–2229CrossRefPubMedPubMedCentral
17.
go back to reference Cole WC, Balent EM, Masella PC, Kajiura LN, Matsumoto KW, Pierce LM (2014) An experimental comparison of the effects of bacterial colonization on biologic and synthetic meshes. Hernia 19:197–205CrossRefPubMed Cole WC, Balent EM, Masella PC, Kajiura LN, Matsumoto KW, Pierce LM (2014) An experimental comparison of the effects of bacterial colonization on biologic and synthetic meshes. Hernia 19:197–205CrossRefPubMed
18.
go back to reference Perez-Kohler B, Sotomayor S, Rodriguez M, Gegundez MI, Pascual G, Bellon JM (2015) Bacterial adhesion to biological versus polymer prosthetic materials used in abdominal wall defect repair: do these meshes show any differences in vitro? Hernia. doi:10.1007/s10029-015-1378-1 PubMed Perez-Kohler B, Sotomayor S, Rodriguez M, Gegundez MI, Pascual G, Bellon JM (2015) Bacterial adhesion to biological versus polymer prosthetic materials used in abdominal wall defect repair: do these meshes show any differences in vitro? Hernia. doi:10.​1007/​s10029-015-1378-1 PubMed
19.
go back to reference Deeken CR, Eliason BJ, Pichert MD, Grant SA, Frisella MM, Matthews BD (2012) Differentiation of biologic scaffold materials through physiomechanical, thermal, and enzymatic degradation techniques. Ann Surg 255:595–604CrossRefPubMed Deeken CR, Eliason BJ, Pichert MD, Grant SA, Frisella MM, Matthews BD (2012) Differentiation of biologic scaffold materials through physiomechanical, thermal, and enzymatic degradation techniques. Ann Surg 255:595–604CrossRefPubMed
20.
go back to reference Jenkins ED, Yip M, Melman L, Frisella MM, Matthews BD (2010) Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products. J Am Coll Surg 210:402–410CrossRefPubMed Jenkins ED, Yip M, Melman L, Frisella MM, Matthews BD (2010) Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products. J Am Coll Surg 210:402–410CrossRefPubMed
21.
go back to reference Pierce RA, Perrone J, Nimeri A, Sexton J, Walcutt J, Frisella M, Matthews B (2009) 120-day comparative analysis of adhesion grade and quantity, mesh contraction, and tissue response to a novel omega-3 fatty acid bioabsorbable barrier macroporous mesh after intraperitoneal placement. Surg Innov 16:46–54CrossRefPubMed Pierce RA, Perrone J, Nimeri A, Sexton J, Walcutt J, Frisella M, Matthews B (2009) 120-day comparative analysis of adhesion grade and quantity, mesh contraction, and tissue response to a novel omega-3 fatty acid bioabsorbable barrier macroporous mesh after intraperitoneal placement. Surg Innov 16:46–54CrossRefPubMed
22.
go back to reference van’t Riet M, De Vos Van Steenwijk PJ, Bonthuis F, Marquet RL, Steyerberg EW, Jeekel J, Bonjer HJ (2002) Prevention of adhesion to prosthetic mesh: comparison of different barriers using an incisional hernia model. Ann Surg 237:123–128CrossRef van’t Riet M, De Vos Van Steenwijk PJ, Bonthuis F, Marquet RL, Steyerberg EW, Jeekel J, Bonjer HJ (2002) Prevention of adhesion to prosthetic mesh: comparison of different barriers using an incisional hernia model. Ann Surg 237:123–128CrossRef
23.
go back to reference Deeken CR, Matthews BD (2012) Comparison of contracture, adhesion, tissue ingrowth, and histologic response characteristics of permanent and absorbable barrier meshes in a porcine model of laparoscopic ventral hernia repair. Hernia 16:69–76CrossRefPubMed Deeken CR, Matthews BD (2012) Comparison of contracture, adhesion, tissue ingrowth, and histologic response characteristics of permanent and absorbable barrier meshes in a porcine model of laparoscopic ventral hernia repair. Hernia 16:69–76CrossRefPubMed
25.
go back to reference Deeken CR, Matthews BD (2013) Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (poly-4-hydroxybutyrate-PHASIX Mesh) in a porcine model of hernia repair. ISRN Surg 2013:238067CrossRefPubMedPubMedCentral Deeken CR, Matthews BD (2013) Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (poly-4-hydroxybutyrate-PHASIX Mesh) in a porcine model of hernia repair. ISRN Surg 2013:238067CrossRefPubMedPubMedCentral
26.
go back to reference Cavallo JA, Greco SC, Liu J, Frisella MM, Deeken CR, Matthews BD (2015) Remodeling characteristics and biomechanical properties of a crosslinked versus a non-crosslinked porcine dermis scaffolds in a porcine model of ventral hernia repair. Hernia 19:207–218CrossRefPubMed Cavallo JA, Greco SC, Liu J, Frisella MM, Deeken CR, Matthews BD (2015) Remodeling characteristics and biomechanical properties of a crosslinked versus a non-crosslinked porcine dermis scaffolds in a porcine model of ventral hernia repair. Hernia 19:207–218CrossRefPubMed
27.
go back to reference Monteiro GA, Delossantos AI, Rodriguez NL, Patel P, Franz MG, Wagner CT (2013) Porcine incisional hernia model: evaluation of biologically derived intact extracellular matrix repairs. J Tissue Eng 4:2041731413508771PubMedPubMedCentral Monteiro GA, Delossantos AI, Rodriguez NL, Patel P, Franz MG, Wagner CT (2013) Porcine incisional hernia model: evaluation of biologically derived intact extracellular matrix repairs. J Tissue Eng 4:2041731413508771PubMedPubMedCentral
28.
go back to reference Itani KM, Rosen M, Vargo D, Awad SS, Denoto G III, Butler CE, Group RS (2012) Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH study. Surgery 152:498–505CrossRefPubMed Itani KM, Rosen M, Vargo D, Awad SS, Denoto G III, Butler CE, Group RS (2012) Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH study. Surgery 152:498–505CrossRefPubMed
29.
go back to reference Rosen M, Bauer J, Harmaty M, Carbonell AM, Cobb WS, Matthews BD, Goldblatt M, Selzer D, Poulose BK, Hansson BM, Rosman C, Chao J, Jacobsen G (2015) Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Ann Surg.doi:10.1097/SLA.0000000000001601 Rosen M, Bauer J, Harmaty M, Carbonell AM, Cobb WS, Matthews BD, Goldblatt M, Selzer D, Poulose BK, Hansson BM, Rosman C, Chao J, Jacobsen G (2015) Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Ann Surg.doi:10.​1097/​SLA.​0000000000001601​
30.
go back to reference Annor AH, Tang ME, Pui CL, Ebersole GC, Frisella MM, Matthews BD, Deeken CR (2012) Effect of enzymatic degradation on the mechanical properties of biological scaffold materials. Surg Endosc 26:2767–2778CrossRefPubMedPubMedCentral Annor AH, Tang ME, Pui CL, Ebersole GC, Frisella MM, Matthews BD, Deeken CR (2012) Effect of enzymatic degradation on the mechanical properties of biological scaffold materials. Surg Endosc 26:2767–2778CrossRefPubMedPubMedCentral
31.
go back to reference Sahoo S, Delozier KR, Dumm RA, Rosen MJ, Derwin KA (2014) Fiber-reinforced dermis graft for ventral hernia repair. J Mech Behav Biomed Mater 34:320–329CrossRefPubMed Sahoo S, Delozier KR, Dumm RA, Rosen MJ, Derwin KA (2014) Fiber-reinforced dermis graft for ventral hernia repair. J Mech Behav Biomed Mater 34:320–329CrossRefPubMed
32.
go back to reference Martin DP, Badhwar A, Shah DV, Rizk S, Eldridge SN, Gagne DH, Ganatra A, Darois RE, Williams SF, Tai HC, Scott JR (2013) Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res 184:766–773CrossRefPubMed Martin DP, Badhwar A, Shah DV, Rizk S, Eldridge SN, Gagne DH, Ganatra A, Darois RE, Williams SF, Tai HC, Scott JR (2013) Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res 184:766–773CrossRefPubMed
Metadata
Title
Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair
Authors
Jeffrey R. Scott
Corey R. Deeken
Robert G. Martindale
Michael J. Rosen
Publication date
01-09-2016
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 9/2016
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-016-5057-9

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