[Experimental evaluation of a new gelatin-impregnated woven Dacron vascular prosthesis (CL301)]

We investigated the biological response and biodegradation of CL301, a presealed woven Dacron prosthesis (UBE woven) with glutaraldehyde stabilized gelatin. The sealant does not affect its handling characteristics because of the glycerin treatment. The total content of endotoxin in the CL301 was 5.3 +/- 0.5 pg/mg of sealant material (1.7 +/- 0.2 pg/cm2), which was 1/5 and 1/6 of that found in Hemashield and Gelseal, respectively. The pyrogen test was negative and the content was estimated below the minimum pyrogenic doses for thoracic aortic surgery. Five cm-long grafts with a diameter of 10 mm were implanted into the descending thoracic aorta of dogs weighing 10-16 kg. These grafts were retrieved 2 hours, 7, 10 days, 5, 8 and 10 weeks after implantation. Thrombus-free surfaces were 28%, 77%, at 5 and 10 weeks and there was no excessive inflammatory response to the sealant. The total, and the effective sealant remaining were 80.6%, 56.5% at 5 weeks, 60.8%, 38.3% at 10 weeks, respectively. The sealant was removed more rapidly from the inner surface than from the outer. In half of the graft area, the sealant was removed or detached from the Dacron surface 5 weeks after implantation, indicating that delayed resorption of the sealant substantially did not affect the healing process. We conclude that because of the harmless amount of endotoxin and effective sealing for 5 weeks, followed by an acceptable healing process experimentally, CL301 is the presealed Dacron graft of choice for thoracic aortic surgery.