Melega Mathias V, Dos Reis Roberto, Lira Rodrigo Pessoa Cavalcanti, de Oliveira Denise Fornazari, Arieta Carlos Eduardo Leite, Alves Monica
School of Medical Sciences, University of Campinas, São Paulo, Brazil.
School of Medical Sciences, Federal University of Pernambuco (UFPE), Recife, Brazil.
Front Med (Lausanne). 2021 Aug 27;8:700793. doi: 10.3389/fmed.2021.700793. eCollection 2021.
To compare the performance of nylon sutures to that of polyglactin sutures in pediatric patients undergoing cataract surgery. University of Campinas (UNICAMP), Campinas, São Paulo, Brazil A prospective, randomized, partially masked, single-site clinical trial. (https://clinicaltrials.gov/ct2/show/NCT03812640). A total of 80 eyes from 80 patients who underwent pediatric cataract surgery were randomized into two groups in block sizes of four. Group A consisted of 41 patients whose surgical incisions were sutured with polyglactin 10-0 material. Group B consisted of 39 patients whose surgical incisions were sutured with nylon 10-0 material. The primary outcome was frequency of suture-related complications in each group. Secondary outcomes were the frequency with which suture removal was necessary. The incidence of suture-related complications within 6 months of follow up was 0 out of 41 eyes (0.00%) in the polyglactin group and 17 out of 39 eyes (43.59%) in the nylon control group ( < 0.001). In all of the eyes with suture-related complications, the sutures were promptly removed. The most frequent complications were vascularization near the suture (17.95%) and loose sutures (17.95%). No ocular or systemic study-related adverse events were observed. Polyglactin sutures were found to be safe and effective for pediatric patients undergoing cataract surgery. Their lower rate of complications and reduced likelihood of removal (and the subsequent need for general anesthesia) make their use preferrable to that of nylon sutures. This study represents the first controlled randomized clinical trial to compare nylon sutures to polyglactin sutures in pediatric patients undergoing cataract surgery. URL: https://clinicaltrials.gov/ct2/show/, Identifier: NCT03812640.
比较尼龙缝线与聚乙醇酸缝线在接受白内障手术的儿科患者中的性能。巴西圣保罗坎皮纳斯坎皮纳斯大学(UNICAMP) 一项前瞻性、随机、部分遮蔽、单中心临床试验。(https://clinicaltrials.gov/ct2/show/NCT03812640)。 共有80例接受儿科白内障手术的患者的80只眼被随机分为两组,每组4例。A组由41例患者组成,其手术切口用聚乙醇酸10-0材料缝合。B组由39例患者组成,其手术切口用尼龙10-0材料缝合。主要结局是每组中与缝线相关并发症的发生率。次要结局是需要拆线的频率。 在随访6个月内,聚乙醇酸组41只眼中有0只(0.00%)发生与缝线相关的并发症,尼龙对照组39只眼中有17只(43.59%)发生(<0.001)。在所有发生与缝线相关并发症的眼中,缝线均被及时拆除。最常见的并发症是缝线附近血管化(17.95%)和缝线松动(17.95%)。未观察到与眼部或全身研究相关的不良事件。 发现聚乙醇酸缝线对接受白内障手术的儿科患者安全有效。其较低的并发症发生率和拆线可能性降低(以及随后对全身麻醉的需求)使其比尼龙缝线更适合使用。本研究是第一项比较尼龙缝线与聚乙醇酸缝线在接受白内障手术的儿科患者中的对照随机临床试验。 网址:https://clinicaltrials.gov/ct2/show/,标识符:NCT03812640。