Background: Epidural fibrosis is regarded as a cause of failed back surgery syndrome (FBSS) when excessive adhesional/fibrotic scar tissue causes compression, pain or discomfort by tethering of nerve tissue to the surrounding muscle or bone. Fibrosis inhibitors could therefore increase the success rate of spinal surgery and decrease the need for reoperations. In recent years, bioresorbable gels or films for the prevention of peridural fibrosis and post-operative adhesions have been developed that look clinically promising. This included a 100% synthetic, sterile, absorbable gel combinations of carboxymethylcellulose (CMC) and polyethylene oxide (PEO) used to coat the dura to reduce scarring after discectomy which became available in Europe in 2002. However, given the burden of the problem and unfavorable experience with other types of adhesion-reduction agents, our unit decided to evaluate the safety of CMC/PEO in a large population of patients undergoing spinal microdiscectomy for herniation.
Methods: To determine the safety and assess efficacy of carboxymethylcellulose/polyethylene oxide (CMC/PEO) gel as an anti-adhesion gel, a consecutive series of 396 patients undergoing lumbar discectomy performed by one surgeon had CMC/PEO gel administered at the end of surgery. The patients were followed up in accordance with standard clinical practice and records reviewed for side effects, such as skin reactions, general reactions or local fluid collections. Reoperations for recurrent herniation included an evaluation of fibrosis reduction.
Results: No product related complications were observed. Five patients needed reoperations for recurrent herniation. Significant but subjective reduction in fibrosis was observed in these patients.
Conclusion: The findings provide confidence that CMC/PEO gel is well tolerated as an agent to achieve reduction of fibrosis in lumbar disc surgery. Further formal prospective study is recommended in this area of unmet need.
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