Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

Abstract

ObjectiveFailed Back Syndrome (FBS) is unacceptable relief of pain or recurrence of symptoms in patients after spinal surgery, such as laminectomy. One possible cause of FBS is peridural fibrosis (PF). PF is the overproduction of scar tissue adjacent to the dura mater. Bleeding can cause PF after laminectomy. Ostene is an alkylene oxide copolymer material used to stop bleeding from bony surfaces. Floseal is a gelatin thrombin matrix sealant used to assist fibrin formation and to promote coagulation.MethodsTotal of 32 female Sprague–Dawley rats were evenly allotted to 4 experimental groups: laminectomy only, laminectomy + Ostene (Baxter International, Inc., Deerfield, IL, USA), laminectomy + Floseal (Baxter International, Inc., Deerfield, IL, USA), and laminectomy + Adcon-L (aap Implantate AG, Berlin, Germany). After performing total laminectomy, agents were placed over dura mater. Spinal column of test subjects was harvested 6 weeks after laminectomy. Histopathological examination of samples was based on Masson's trichrome and hematoxylin and eosin staining. PF observed in the groups was graded using system previously described by He et al. Statistically significant p value was defined as p < 0.005.ResultsPresent study revealed that Adcon-L, Ostene, and Floseal groups had reduced PF compared with laminectomy only group (p = 0.001). Comparison of Ostene and Floseal groups with Adcon-L group yielded no significant difference.ConclusionReoperation as result of FBS has greater risk and often has poor outcome; surgeons must take precautions to avoid FBS, such as careful selection of appropriate patient and operation technique. Ostene and Floseal may be applied and left in the operation field safely during laminectomy to reduce occurrence of PF after procedure.

Comparison of Ostene® and Bone wax on Bone Healing: A Comparative experimental study in rabbits.

“…Furthermore Ostene® is removed from the body unchanged while bone wax is not. Our results are in agreement with Gurcan et al, 23 who showed that the advantages of Ostene® over bone wax is that Ostene® is absorbed within two days, in addition to that it does not have adverse effects on healing and is excreted unchanged by the body. Nooh et al, 27 informed a foreign body reaction to bone wax in the form of granulomatous inflammation and fibrous encapsulation with the inhibition of bone healing and osteogenesis.…”

“…This revealed that Ostene® has an anti-fibrosis effect in agreement with results from other studies. 19,23 Regarding the histopathological analysis, abundant, poorly organized bony trabeculae with maturation of granulation tissue into the connective tissue was observed the control group during 2 nd week; while at the same period in the Ostene® group more organized granulation tissue with bone trabeculae which increased in number, thickness and organization was visible, in contrast to bone wax group who displayed less bone trabeculae in a disorganized manner, a phenomenon corroborated by other studies. 12…”

“…13,21 Bone wax is a well-known topical hemostatic agent, composed of cera alba (beeswax) (88%) and isopropyl palmitate (12%), a palm oil-based emollient, moisturizer, and thickening and anti-static agent. [22][23][24][25] Bone wax is relatively easy to use, and its application is very simple. It is a non-absorbable hemostatic sealant and it functions as a mechanical tamponade to stop bone bleeding in patients undergoing thoracic, orthopedic, craniofacial and neurosurgery.…”

The effect of the new hemostatic agent Ostene® on bone healing: An experimental study in rabbits

“…Because the size of the defect in our study was small (5mm), this may explain why the granulation tissue was not seen clearly. A study by Gurcan et al, 28 showed Ostene® had antifibrosis effect. This finding is in agreement with our results.…”

Efficacy of Local Haemostatic Agent Following Minor Surgery (An Experimental and Clinical Study)

“…This came in agreement with the study of Vestergaard et al as they found Ostene to stick well to the bone and acts as a mechanical obstacle which precludes blood emerge from bare spongy osseous tissue thus inducing hemostasis (24) . Further study showed that ostene is suitable to arrest bleeding as it is an inert hydrophilic material that does not interfere with coagulation properties, absorbed within 48hours and eliminated from the body unchanged (25) . When comparing ostene with gelfoam both clinically and experimentally, ostene appeared better than gelfoam in controlling bleeding with the latter inducing infection when left inside the socket.…”