The change in strength over time of a biomaterial derived from the small in
testinal submucosa (SIS) was determined in a dog model of body wall repair.
Full-thickness body wall defects measuring 8 x 12 cm were surgically creat
ed and then repaired with a multilaminate eight-layer form of SIS in 40 dog
s. Five dogs were sacrificed at each of the following time points: 1 day, 4
days, 7 days, 10 days, and 1, 3, 6, and 24 months. Ball burst tests that m
easured biaxial ultimate load-bearing capability were performed on the devi
ce prior to implantation and on the device/implant site at the time of sacr
ifice. The strength of the device at the time of implant was approximately
73 +/- 12 pounds. The strength of the implant site diminished to 40 +/- 18
pounds at 10 days, and then progressively increased to a value of 156 +/- 2
6 pounds at 24 months (P < 0.05). The clinical utility of a degradable biom
aterial such as SIS depends on a balance between the rate of degradation an
d the rate of host remodeling. Naturally occuring extracellular matrix scaf
folds such as SIS show rapid degradation with associated and subsequent rem
odeling to a tissue with strength that exceeds that of the native tissue wh
en used as a body wall repair device. (C) 2001 Academic Press.