Safety and effectiveness of a XXXX barrier in reducing risks of vascular tissue damage during anterior spinal revision surgery.

@entity32 @entity939 @entity4832 @entity742 @entity158
STUDY DESIGN: This study was conducted as a controlled, prospective investigation to show the safety and efficacy of a @entity4832 ( @entity939 ) device in a @entity742 model. OBJECTIVE: To evaluate the ability of a permanent @entity939 hydrogel barrier to reduce the risk of potential vessel damage during anterior vertebral revision surgery, to provide a nonadhesive barrier at the surgical site, and to create a surgical revision plane of dissection. BACKGROUND: The development of scar tissue and adhesions presents a significant postoperative problem in spine surgery, where adhesion involvement of overlying structures can cause @entity158 , and present a difficult surgical environment during revisions. METHODS: The devices were implanted onto the ventral surface of exposed lumbar intervertebral discs using an anterolateral approach. One disc separated from the study site was also exposed to serve as a control. Three @entity742 each were then evaluated with an explant procedure at 30 and 90 days. Extensive sampling was undertaken to evaluate gross anatomic, micropathologic, and biochemical environments and properties of the device. RESULTS: The structural properties and appearance of the device remained intact at both 30 and 90 days. The material remained flexible, hydrophilic, and soft, without visible resorption or decomposition. The material was well tolerated by the animal, with minimal histologic signs of @entity32 or rejection. Tissue planes were easily able to be localized by the surgeon attempting to locate the prior surgical site at the time of resection. CONCLUSIONS: The @entity939 vessel shield effectively protected the structures overlying the @entity742 spine during revision, providing a clear dissection plane for resection at repeat surgery. The overlying structures separated from the previous surgical site with no adhesion, and allowed safe separation of adjacent tissues without the use of sharp dissection.
