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
Purpose. Poly-4-hydroxybutyrate (P4HB) is a naturally derived, absorbable polymer. P4HB has been manufactured into PHASIX Mesh and P4HB Plug designs for soft tissue repair. The objective of this study was to evaluate mechanical strength, resorption properties, and histologic characteristics in a porcine model. Methods. Bilateral defects were created in the abdominal wall of Yucatan minipigs and repaired in a bridged fashion with PHASIX Mesh or P4HB Plug fixated with SorbaFix or permanent suture, respectively. Mechanical strength, resorption properties, and histologic characteristics were evaluated at 6, 12, 26, and 52 weeks ( each). Results. PHASIX Mesh and P4HB Plug repairs exhibited similar burst strength, stiffness, and molecular weight at all time points, with no significant differences detected between the two devices ( ). PHASIX Mesh and P4HB Plug repairs also demonstrated significantly greater burst strength and stiffness than native abdominal wall at all time points ( ), and material resorption increased significantly over time ( ). Inflammatory infiltrates were mononuclear, and both devices exhibited mild to moderate granulation tissue/vascularization. Conclusions. PHASIX Mesh and P4HB Plug demonstrated significant mechanical strength compared to native abdominal wall, despite significant material resorption over time. Histological assessment revealed a comparable mild inflammatory response and mild to moderate granulation tissue/vascularization. 1. Introduction Biological scaffold materials derived from dermis, pericardium, and small intestine submucosa of human, bovine, and porcine origin have been utilized over the last decade for soft tissue repair applications such as hernia repair [1], breast reconstruction [2], staple-line reinforcement [3], and orthopedic applications [4]. These scaffold materials are particularly useful in clean-contaminated or contaminated settings due to their rapid revascularization and clearance of bacteria [5, 6]. Permanent, synthetic polymer mesh materials are not typically utilized in these settings due to risk of infection [7]. Biological scaffolds are also utilized as an alternative to fascial closure when there is excessive tension on the wound, when tissue loss makes closure especially difficult, or in “damage-control”/abdominal compartment settings in which the abdomen must be left open until the patient is stabilized [8]. In these settings, scaffolds are utilized to protect the abdominal contents, typically until granulation of the wound occurs and a split-thickness skin graft can be applied. Although
References
[1]
C. R. Deeken, B. J. Eliason, M. D. Pichert, S. A. Grant, M. M. Frisella, and B. D. Matthews, “Differentiation of biologic scaffold materials through physiomechanical, thermal, and enzymatic degradation techniques,” Annals of Surgery, vol. 255, no. 3, pp. 595–604, 2012.
[2]
K. H. Breuing and A. S. Colwell, “Inferolateral AlloDerm hammock for implant coverage in breast reconstruction,” Annals of Plastic Surgery, vol. 59, no. 3, pp. 250–255, 2007.
[3]
A. Assalia, K. Ueda, R. Matteotti, F. Cuenca-Abente, T. Rogula, and M. Gagner, “Staple-line reinforcement with bovine pericardium in laparoscopic sleeve gastrectomy: experimental comparative study in pigs,” Obesity Surgery, vol. 17, no. 2, pp. 222–228, 2007.
[4]
J. L. Cook, D. B. Fox, K. Kuroki, M. Jayo, and P. G. De Deyne, “In vitro and in vivo comparison of five biomaterials used for orthopedic soft tissue augmentation,” American Journal of Veterinary Research, vol. 69, no. 1, pp. 148–156, 2008.
[5]
M. E. Franklin, J. M. Trevi？o, G. Portillo, I. Vela, J. L. Glass, and J. J. González, “The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: Long-term follow-up,” Surgical Endoscopy and Other Interventional Techniques, vol. 22, no. 9, pp. 1941–1946, 2008.
[6]
K. C. Harth, A. M. Broome, M. R. Jacobs et al., “Bacterial clearance of biologic grafts used in hernia repair: an experimental study,” Surgical Endoscopy and Other Interventional Techniques, vol. 25, no. 7, pp. 2224–2229, 2011.
[7]
A. M. Carbonell, B. D. Matthews, D. Dréau et al., “The susceptibility of prosthetic biomaterials to infection,” Surgical Endoscopy and Other Interventional Techniques, vol. 19, no. 3, pp. 430–435, 2005.
[8]
L. N. Tremblay, D. V. Feliciano, J. Schmidt et al., “Skin only or silo closure in the critically ill patient with an open abdomen,” American Journal of Surgery, vol. 182, no. 6, pp. 670–675, 2001.
[9]
J. Zieren, E. Castenholz, E. Baumgart, and J. M. Müller, “Effects of fibrin glue and growth factors released from platelets on abdominal hernia repair with a resorbable PGA mesh: experimental study,” Journal of Surgical Research, vol. 85, no. 2, pp. 267–272, 1999.
[10]
S. Sriussadaporn, S. Sriussadaporn, R. Pak-Art, K. Krittayakirana, and S. Prichayuhd, “Planned ventral hernia with absorbable mesh: a life-saving method in relaparotomy for septic abdomen,” Journal of the Medical Association of Thailand, vol. 93, no. 4, pp. 449–456, 2010.
[11]
M. T. Dayton, B. A. Buchele, S. S. Shirazi, and L. B. Hunt, “Use of an absorbable mesh to repair contaminated abdominal-wall defects,” Archives of Surgery, vol. 121, no. 8, pp. 954–960, 1986.
[12]
A. M. Tobias and D. W. Low, “The use of a subfascial Vicryl mesh buttress to aid in the closure of massive ventral hernias following damage-control laparotomy,” Plastic and Reconstructive Surgery, vol. 112, no. 3, pp. 766–776, 2003.
[13]
A. Pans, P. Elen, W. Dewé, and C. Desaive, “Long-term results of polyglactin mesh for the prevention of incisional hernias in obese patients,” World Journal of Surgery, vol. 22, no. 5, pp. 479–483, 1998.
[14]
R. D. Rice, F. S. Ayubi, Z. J. Shaub, D. M. Parker, P. J. Armstrong, and J. W. Tsai, “Comparison of surgisis, AlloDerm, and Vicryl Woven Mesh grafts for abdominal wall defect repair in an animal model,” Aesthetic Plastic Surgery, vol. 34, no. 3, pp. 290–296, 2010.
[15]
M. W. Laschke, J. M. H？ufel, C. Scheuer, and M. D. Menger, “Angiogenic and inflammatory host response to surgical meshes of different mesh architecture and polymer composition,” Journal of Biomedical Materials Research B, vol. 91, no. 2, pp. 497–507, 2009.
[16]
J. P. Lamb, T. Vitale, and D. L. Kaminski, “Comparative evaluation of synthetic meshes used for abdominal wall replacement,” Surgery, vol. 93, no. 5, pp. 643–648, 1983.
[17]
J. A. Blatnik, D. M. Krpata, M. R. Jacobs, Y. W. Novitsky, and M. J. Rosen, “Effect of wound contamination on modern absorbable synthetic mesh,” Abdominal Wall Reconstruction conference abstract, June 2011.
[18]
P. L. Burgess, J. R. Brockmeyer, and E. K. Johnson, “Amyand hernia repaired with Bio-A: a case report and review,” Journal of Surgical Education, vol. 68, no. 1, pp. 62–66, 2011.
[19]
M. Efthimiou, D. Symeonidis, G. Koukoulis, K. Tepetes, D. Zacharoulis, and G. Tzovaras, “Open inguinal hernia repair with the use of a polyglycolic acid-trimethylene carbonate absorbable mesh: a pilot study,” Hernia, vol. 15, no. 2, pp. 181–184, 2011.
[20]
GORE BIO-A Product Brochure, 2011, http://www.goremedical.com/resources/dam/assets/AQ3037-EN2.pdf.
[21]
H. . Hjort, T. Mathisen, A. Alves, G. Clermont, and J. P. Boutrand, “Three-year results from a preclinical implantation study of a long-term resorbable surgical mesh with time-dependent mechanical characteristics,” Hernia, vol. 16, no. 2, pp. 191–197, 2012.
[22]
F. Ruizjasbon and Norrby, “Six Months Results of First-In-Man Trial of a New Synthetic Long-Term Resorbable Mesh for Inguinal Hernia Repair,” European Hernia Society, Istanbul, Turkey, October 2010.
[23]
D. P. Martin and S. F. Williams, “Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial,” Biochemical Engineering Journal, vol. 16, no. 2, pp. 97–105, 2003.
[24]
S. P. Hoerstrup, R. Sodian, S. Daebritz et al., “Functional living trileaflet heart valves grown in vitro,” Circulation, vol. 102, no. 19, pp. III44–III49, 2000.
[25]
U. A. Stock, T. Sakamoto, S. Hatsuoka et al., “Patch augmentation of the pulmonary artery with bioabsorbable polymers and autologous cell seeding,” Journal of Thoracic and Cardiovascular Surgery, vol. 120, no. 6, pp. 1158–1168, 2000.
[26]
S. P. Hoerstrup, G. Zünd, R. Sodian, A. M. Schnell, J. Grünenfelder, and M. I. Turina, “Tissue engineering of small caliber vascular grafts,” European Journal of Cardio-Thoracic Surgery, vol. 20, no. 1, pp. 164–169, 2001.
[27]
E. Odermatt, L. Funk, R. Bargon, D. P. Martin, S. Rizik, and S. F. Williams, “MonoMax suture: a new long-term absorbable monofilament suture made from poly-4-hydroxybutyrate,” International Journal of Polymer Science, vol. 2012, Article ID 216137, 12 pages, 2012.
[28]
C. R. Deeken and B. D. Matthews, “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, vol. 16, no. 1, pp. 69–76, 2011.
[29]
C. R. Deeken, M. S. Abdo, M. M. Frisella, and B. D. Matthews, “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair,” Surgical Endoscopy and Other Interventional Techniques, vol. 25, no. 5, pp. 1541–1552, 2011.
[30]
C. R. Deeken, M. S. Abdo, M. M. Frisella, and B. D. Matthews, “Physicomechanical evaluation of polypropylene, polyester, and polytetrafluoroethylene meshes for inguinal hernia repair,” Journal of the American College of Surgeons, vol. 212, no. 1, pp. 68–79, 2011.
