Efficacy and biocompatibility of a photopolymerized, synthetic, absorbable hydrogel as a dural sealant in a canine craniotomy model.

OBJECT A canine craniotomy model was used to evaluate the dural sealing efficacy and biocompatibility of a novel, synthetic, bioresorbable hydrogel. METHODS Bilateral craniotomies were performed in 24 dogs assigned to six survival periods. In each animal a parasagittal durotomy was created and then repaired. At the treatment sites the hydrogel sealant was applied over the dural repair and photopolymerized. The repair was tested for leaks to 20 cm H2O by using a Valsalva maneuver. At the control sites the incisions were sutured and tested for leaks only. After uneventful survival periods, the leak test was repeated in three of the four animals in each group. Bone-dura adhesion was evaluated, after which the dura and underlying brain were removed, fixed, and examined histologically. En bloc histological investigation was performed on a specimen obtained from the fourth animal in each group. Over a 56-day period, 18 treated sites were tested for leaks. A leak was detected at a site remote from that of the repair in one animal; this was excluded from analysis. Thus 17 of 17 treated sites remained free of leaks. On the control side of one animal, there was a leak from a new dural tear at the cranial end of the durotomy, which occurred when the bone flap was removed. This site was also excluded from analysis. Eleven of 17 leak-tested control sites remained free of leaks over the study period. Bone-dura adhesions occurred in 15 of 19 control sites and had a mean adhesion score of 1.37 (range 0-4), whereas adhesions occurred in 10 of 19 treated sites with a mean adhesion score of 0.84 (range 0-3). No cortical reaction was noted. CONCLUSIONS This novel hydrogel sealant is efficacious in sealing dural repair sites measuring up to 2 mm. Healing of the underlying dura is not compromised and exposed cortical tissue is not altered histologically.