Automatic knot fastener Cor-Knot and United States Pharmacopeial Convention CLASS I knot pull-apart force safety regulations

Objective was to evaluate security of sutures fixated with automatic knot fastener Cor-Knot and compare to United States Pharmacopeial Convention (USP) regulations for use in minimally invasive surgery. In vitro we measured the knot pull-apart force (KPAF) for two 2-0 B. Braun PremiCron suture lots - Lot#1-9364 (24 sutures); Lot#110095 (24 sutures), fixated using Cor-Knot devices. USP Class I minimum average 2-0 suture KPAF is defined as 28.24 newtons. For Lot#1-9364 we measured 46.84 ± 1.97 N (mean ± std dev); for Lot#110095 it was 54.08 ± 2.57 N. There were no statistically significant differences between the two lots (F-test, p=0.102). KPAF for all 48 tested knots was higher than USP Class I. Minimal KPAF - 39.27 N (suture P/N M0027845; Lot#110095) is approximately 11 N above the USP recommendation. To conclude, Cor-Knot-fastened 2-0 B. Braun PremiCron sutures showed a much higher KPAF compared to the USP regulation recommendations.