Jing-Wen Gong1,2, Jun-Hao Chen1,2, Ting Shen1,2, Jin Jiang3,4. 1. Department of Ophthalmology, Zhejiang Provincial People's Hospital, 158, Shangtang Road, Hangzhou, 310014, ZheJiang, China. 2. People's Hospital of Hangzhou Medical College, Hangzhou, 310014, ZheJiang, China. 3. Department of Ophthalmology, Zhejiang Provincial People's Hospital, 158, Shangtang Road, Hangzhou, 310014, ZheJiang, China. jjzryk@163.com. 4. People's Hospital of Hangzhou Medical College, Hangzhou, 310014, ZheJiang, China. jjzryk@163.com.
Abstract
PURPOSE: To introduce a novel practical technique of self-made cryopreservative fibrin glue (SMC) applied in pterygium surgery and to assess its safety and efficacy. METHODS:Forty-eight eyes of 48 patients with nasal primary pterygium were enrolled. The patients were equally assigned to 6 groups. Self-made fibrin glue was subpackaged and, respectively, cryopreserved for 3, 7, 15 days and 1, 2 and 3 months. At each time point, the asepsis of SMC was confirmed by bacterial culture and colony counting. In each group, corresponding SMC was applied to fix the autograft after the pterygium was removed (e.g., SMC 3d for group 1 and SMC 3m for group 6). All the patients were followed up postoperatively on days 1, 3, 7 and 14 and then at months 1, 3, 6. The main outcome measures included fixation success rate within two tries, postoperative discomfort, recurrence rate and complications. RESULTS: No colony growth was observed in all the fibrinogen and thrombin tubes sent. Five patients needed a second try with respective SMC during the autograft fixation, and there were no significant differences in SMC use times among the groups (P = 0.885). There were no significant differences in postoperative discomfort (day 1, 3, 7; P = 0.651, P = 0.269, P = 0.180, respectively) among the groups. By the end of 6-m follow-up, no infections and severe complications were observed in any group. The total recurrence rate was 3/48 (6%), and there were no significant differences in recurrences among the groups (P = 1.000). CONCLUSION:SMC is safe and effective for autograft fixation in pterygium surgery. This new practical technique will benefit the patients and surgeons in developing and underdeveloped country.
RCT Entities:
PURPOSE: To introduce a novel practical technique of self-made cryopreservative fibrin glue (SMC) applied in pterygium surgery and to assess its safety and efficacy. METHODS: Forty-eight eyes of 48 patients with nasal primary pterygium were enrolled. The patients were equally assigned to 6 groups. Self-made fibrin glue was subpackaged and, respectively, cryopreserved for 3, 7, 15 days and 1, 2 and 3 months. At each time point, the asepsis of SMC was confirmed by bacterial culture and colony counting. In each group, corresponding SMC was applied to fix the autograft after the pterygium was removed (e.g., SMC 3d for group 1 and SMC 3m for group 6). All the patients were followed up postoperatively on days 1, 3, 7 and 14 and then at months 1, 3, 6. The main outcome measures included fixation success rate within two tries, postoperative discomfort, recurrence rate and complications. RESULTS: No colony growth was observed in all the fibrinogen and thrombin tubes sent. Five patients needed a second try with respective SMC during the autograft fixation, and there were no significant differences in SMC use times among the groups (P = 0.885). There were no significant differences in postoperative discomfort (day 1, 3, 7; P = 0.651, P = 0.269, P = 0.180, respectively) among the groups. By the end of 6-m follow-up, no infections and severe complications were observed in any group. The total recurrence rate was 3/48 (6%), and there were no significant differences in recurrences among the groups (P = 1.000). CONCLUSION: SMC is safe and effective for autograft fixation in pterygium surgery. This new practical technique will benefit the patients and surgeons in developing and underdeveloped country.