A potential complication of lumbo-sacral surgery is the inadvertent tear of the dura mater, which sometimes eludes intra-operative detection.
ADCON-L, a bioabsorbable gel used in lumbosacral
laminectomies or
laminotomies, is a physical barrier to post-operative epidural
fibrosis. Three experimental lumbar
laminectomy studies were designed to assess in vivo the effects of
ADCON-L when applied in presence of dural
punctures in a rat model. In the first study, the durotomy was repaired with
fibrin sealant, in the second experiment the dural defect was microsurgically sutured, while in a third protocol the durotomy was left unrepaired. In each study, dural healing was assessed respectively at 4, 8, or 12 weeks post-operatively. Blinded anatomical dissection and histopathology were used to compare results between treatments (
sham operated control vs.
ADCON-L). In the
fibrin sealant experiment, an additional treatment group (
fibrin sealant used together with
ADCON-L) was included. The results of these studies consistently demonstrate that
ADCON-L is an effective anti-fibrotic agent, and does not interfere with the normal dural healing processes following a meningeal
puncture. The application of the gel may therefore be safe in presence of dural incisions, even when they are not identified during surgery, as demonstrated in these in vivo studies.