Comparison of a caprolactone/lactide film (mesofol) to two polylactide film products as a barrier to postoperative peridural adhesion in an ovine dorsal laminectomy model

Abstract

Study design: Experimental study.

Objective: To evaluate and compare the performances of 2 bioresorbable products, Mesofol (a caprolactone/lactide film) and Lactosorb (a polylactide film), as barriers to postoperative peridural adhesions and fibrosis.

Summary of background data: Postoperative peridural adhesions from scar tissue may be an inciting cause of chronic pain and dysfunction in "failed back" syndrome. Many biocompatible products and drugs, as well as autografts have been tested as antiadhesion barriers with varying success.

Methods: The bioresorbable film products were used to cover large laminectomy defects in 11 sheep. Three laminectomy defects were created, with 2 randomly assigned treatment sites and 1 control site in each animal. A tear was created in the dura allowing cerebrospinal fluid leakage to assess for impaired dural healing. Performance of the film barriers was assessed at 10 weeks postoperative by gross scar and tenacity scoring by 3 blinded, independent observers in 7 animals. Histology was performed in 4 animals. New Methylene blue dye myelography and magnetic resonance imaging were performed to assess for cerebrospinal fluid leakage. Magnetic resonance imaging was also used to evaluate the imaging characteristics of adhesions.

Results: All 3 products evaluated showed a benefit to prevention of postoperative peridural adhesion; the performance of Mesofol was deemed superior to either of the 2 Lactosorb products. The handling characteristics of all products were compatible with clinical usage. Impairment to healing of dural tears or active inflammation was not identified with any product.

Conclusion: The results of this investigation support previous studies on the benefit of polylactide film barriers, like Lactosorb, for reducing peridural adhesion following spinal surgery. The performance of Mesofol in this investigation suggests that it may provide improved antiadhesion properties in comparison to the polylactide products. Safety issues related to impaired dural healing was not identified in either product.