Background
A model for assessing GI healing following surgical stapling with and without staple line reinforcement materials (SLR) used in conjunction with Tri-StapleTM technology was developed; this model was established to score tissue abrasion and/or adhesion(s) at the wound site for comparative evaluation.

Material and methods
The surgical procedure comprising a modified Billroth II with jejujejunostomy, was performed in eighteen subjects. On Day 14 or 15 animals were euthanized and staple lines were evaluated grossly and according to grading scales for the extent, length and maturity of adhesion(s) present, and for tissue abrasion length and depth. Comparative analyses of the samples’ scores were performed using statistical analyses and overall change in subject weight was tracked.

Results
The pilot study demonstrated some differences in adhesion extent between reinforced and non- reinforced staple lines; most adhesions were graded as “mature”, requiring sharp dissection for removal. For the pivotal study the adhesion extent between reinforcement materials was equivalent. No abrasions to adjacent tissues were caused by either the control Tri-StapleTM lines or the materials tested. Weight loss ranged from 4-14.3% through Day 14 or 15.

Conclusion
The modified Billroth II with jejujejunostomy procedure was well tolerated by all subjects, with limited weight loss. The model was suitable for evaluating and comparing post-operative adhesions to staple lines with and without reinforcement materials. The model was less effective for meaningfully evaluating abrasions since staple line placement sites were in areas considered to be fairly immobile, limiting relative motion of staple lines against adjacent tissues.