Safety evaluation of a laxity-minimizing suture at 5 days and 6 weeks after repair of a sheep infraspinatus tendon.

BACKGROUND: The ideal rotator cuff repair achieves high initial fixation strength and secure tendon-to-bone apposition until biological healing occurs. A suture that reacts to the local stress environment by minimizing suture laxity across the repair could theoretically maintain soft-tissue apposition to bone and therefore improve healing. METHODS: By use of an in vivo ovine shoulder model, the infraspinatus tendon was transected and then repaired with either a laxity-minimizing suture or a traditional high tensile suture. The purpose of this study was to evaluate both sutures' safety at 5 days and 6 weeks after repair. RESULTS: The macroscopic and microscopic analyses of the repair sites showed similar amounts of surgical trauma. There was no evidence of cheese wiring or tissue necrosis of the repaired tendons for either suture. There was no evidence of systematic toxicity in any animal. The maximum gap between cut edges of the tendon for repairs with the predicate suture was approximately twice the gap for the laxity-minimizing suture. CONCLUSION: The laxity-minimizing suture was as safe at 5 days and 6 weeks as the predicate suture. Neither suture contributed to local tissue damage or particle generation leading to adverse systematic consequences. An additional observation was that the maximum gap between cut edges of the tendon for repairs with the predicate suture was approximately twice the gap for the laxity-minimizing suture.

Improved bleeding scores using Gelfoam(®) Powder with incremental concentrations of bovine thrombin in a swine liver lesion model.

Topical hemostatic agents are used intra-operatively to prevent uncontrolled bleeding. Gelfoam(®) Powder contains a hemostatic agent prepared from purified pork skin gelatin, the efficacy of which is increased when combined with thrombin. However, the effect of increasing concentrations of thrombin on resultant hemostasis is not known. This study sought to evaluate the ability of various concentrations of thrombin in combination with Gelfoam Powder to control bleeding using a swine liver lesion model. Ten pigs underwent a midline laparotomy. Circular lesions were created in the left medial, right medial, and left lateral lobes; six lesions per lobe. Gelfoam Powder was hydrated with Thrombin-JMI(®) diluted to 250, 375, and 770 IU/mL. Each concentration was applied to two lesion sites per lobe. Bleeding scores were measured at 3, 6, 9, and 12 min using a 6-point system; comparison of bleeding scores was performed using ANOVA with the post hoc Tukey test. The bleeding scores with thrombin concentrations at 770 IU/mL were significantly lower than at 250 and 375 IU/mL at all four time points. The percentage of biopsies with a clinically acceptable bleeding score rose from 37.9, 46.6, and 71.2 % at 3 min to 55.2, 69.0, and 88.1 % at 12 min in the 250, 375, and 770 IU/mL thrombin groups, respectively. The study showed that the hemostatic response to thrombin was dose-related: using higher concentrations of thrombin with Gelfoam Powder yielded improved hemostasis, as determined by lower bleeding scores.