duraSeal: Surgical Sealant for the Reduction of csf leaks in cranial and spinal surgery

摘要

it has long been recognized that incision line closure of the dura mater using suture alone during cranial and spinal surgery is not always adequate to prevent cerebral spinal fluid (CSF) leakage. CSF leakage can result in serious morbidity issues such as infection and often requires the use of drains. Although several synthetic and natural biomaterials have been used they all lack some or all of the necessary requirements of a successful surgical sealant. These characteristics, among many others, include cohesive and adhesive strength and the ability to allow for wound healing while degrading into non-toxic metabolites over the proper time frame. The commercial launch of DuraSeal provided surgeons with the first FDA approved absorbable sealant for cranial CSF leaks. This presentation will discuss the formulation, clinical evaluation and health care economics of this "first in class" cranial and spinal surgical sealant.