Abstract
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 n = 20 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 (n = 5 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 (P > 0.05). PHASIX Mesh and P4HB Plug repairs also demonstrated significantly greater burst strength and stiffness than native abdominal wall at all time points (P < 0.05), and material resorption increased significantly over time (P < 0.001). 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.
Highlights
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]
When PHASIX Mesh was evaluated in the direction parallel to the longest dimension of the interstices, the suture retention strength was 59.16 ± 5.7 N, which was greater than the 20 N suture retention strength suggested for hernia repair applications [29, 30]
When PHASIX Mesh was evaluated in the direction parallel to the longest dimension of the interstices, the tear resistance strength was 30.33 ± 3.1 N, which was greater than the 20 N tear resistance strength suggested for hernia repair applications [29, 30]
Summary
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]. Biological scaffolds are 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. Designs of absorbable polymer scaffolds included materials such as DEXON (Covidien, Mansfield, MA) and VICRYL (Ethicon, Inc., Somerville, NJ)
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