Abstract
Abstract: :
Purpose: To study the efficacy and biotolerance of ADAL-2® bioadhesive in conjunctival sealing. Methods: A double masked randomized study was done. 50 eyes (post surgery) were assigned to one of two groups. Group I: conjunctival suture with Vicryl® 8-0, Group II: conjunctival sealing with ADAL-2® bioadhesive. Patients had undergone either surgery for cataract, strabismus or pterygium. (35 female, 15 male. Average age 49.54 ± 28.76 years (range 28-75). Patients were assessed up to one month post-up as follows: Efficacy of closure of wound site by microscopy. Inflammatory reaction (edema, injection, secretion type, incidence of ulcers, and conjunctival disruption Presence of residual material (adhesive or suture). Patient self-assessment of comfort (graded scale). Results: Efficacy of conjunctival sealing: The conjunctiva was closed 88% (22 cases) in the wound site, 8% (2 cases) was open, and displaced 4% (1 case), in the Group I. 96% (24 cases) was closed in the wound site and 4% (1 case) sealed, but displaced in the Group II. Inflammatory reaction: There weren't significant differences in different periods studied between both groups. (p=0,358; p=0,366; p=0,543). There were statistical differences in the conjunctival edema (p=0,003) at 2 weeks. There was high percentage (28%, 7 cases) of ulcers and conjunctiva holes present, at the early postoperative periods (3 and 15 days) in the Group I. Presence of residual material: There weren't significant differences (p≷0,005) between both groups. There were statistical difference in subjective comfort (p=0,005). The patients of adhesive group referred less discomfort than suture group. Conclusion: The efficacy of ADAL-2® adhesive and Vicryl 8-0 suture for the conjunctiva are comparable. The ADAL-2® adhesive is well tolerated and produces less discomfort than traditional sutures.
Keywords: 356 clinical (human) or epidemiologic studies: systems/equipment/techniques • 437 inflammation • 365 conjunctiva