RESUMEN
BACKGROUND: The goal of this study was to compare the physical and functional properties of coated polyglactin 910 suture with and without triclosan by human assessment and instrument-based measurements. METHODS: Surgeons specializing in general, orthopedic, plastic, or gynecologic surgery evaluated the suture materials in an in vivo porcine model with regard to (1) ease of passage through tissue, (2) first-throw knot holding, (3) knot tie-down smoothness, (4) knot security, (5) surgical handling, and (6) overall evaluation. Breaking strength retention was determined at 14, 21, 28, and 35 days post-implantation in rats using a tensile strength measurement device. The absorption rate was determined in rats by histopathology at 7, 28, 56, 63, 70, and 77 days post-implantation. The tactile smoothness and tie-down behavior of both wet and dry sutures were evaluated by product characterization technicians. RESULTS: The scores for surgeons' evaluation of suture material were favorable and similar for both sutures. Surgeons could not reliably make a distinction in handling between the two sutures. Breaking strength retention was the same for both sutures, ranging from 79% on day 14 to 5% on day 35. Both sutures were essentially absorbed at 70 days post-implantation. Product characterization assessment of the two sutures found them to be indistinguishable. CONCLUSION: The addition of triclosan to coated polyglactin 910 sutures did not affect physical handling properties or performance characteristics based on the testing and evaluations performed.