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一种用于伤口修复的新型高粘度氰基丙烯酸辛酯组织粘合剂的评估:一项随机临床试验。

Evaluation of a new high-viscosity octylcyanoacrylate tissue adhesive for laceration repair: a randomized, clinical trial.

作者信息

Singer Adam J, Giordano Philip, Fitch Jeffrey L, Gulla Janet, Ryker Dennis, Chale Stuart

机构信息

Department of Emergency Medicine, Stony Brook University, Stony Brook, NY11794-7400, USA.

出版信息

Acad Emerg Med. 2003 Oct;10(10):1134-7. doi: 10.1111/j.1553-2712.2003.tb00588.x.

Abstract

OBJECTIVE

Tissue adhesives have recently been approved for skin closure. Their low viscosity may result in inadvertent migration. The authors compared the tendency of the adhesive to migrate after laceration closure with a high- or low-viscosity octylcyanoacrylate (OCA).

METHODS

This was a randomized, clinical trial set in university and community-based emergency departments. Participants included patients with simple traumatic lacerations. Patients were randomized to laceration closure with low- or high-viscosity OCA tissue adhesive. The outcome measured was immediate adhesive migration (interobserver agreement, kappa = 0.90). Data analysis was performed with proportions compared with chi-square and Fisher's exact tests.

RESULTS

Eighty-four patients were randomized to low- (n = 42) or high- (n = 42) viscosity OCA tissue adhesive. Groups were similar in baseline patient and wound characteristics. The high-viscosity OCA was less likely to migrate than the lower-viscosity agent (21% vs. 78%, p < 0.001; odds ratio = 0.3, 95% confidence interval = 0.1 to 0.5). The proportion of patients who noted a sensation of heat during OCA application was higher in the high-viscosity groups (44% vs. 26% respectively, p = 0.11); however, all such patients in both groups would use the device again. At 14 days, there were no wound infections in either group. There was one dehiscence in the high-viscosity group.

CONCLUSIONS

The high-viscosity OCA tissue adhesive was less likely to migrate than the lower-viscosity device. Wound dehiscence and infection rates were acceptably low in both treatment groups.

摘要

目的

组织粘合剂最近已被批准用于皮肤缝合。其低粘度可能导致意外迁移。作者比较了使用高粘度或低粘度氰基丙烯酸辛酯(OCA)进行伤口缝合后粘合剂迁移的倾向。

方法

这是一项在大学和社区急诊科进行的随机临床试验。参与者包括单纯性创伤性撕裂伤患者。患者被随机分配使用低粘度或高粘度OCA组织粘合剂进行伤口缝合。测量的结果是粘合剂的即时迁移(观察者间一致性,kappa = 0.90)。数据分析采用比例比较,并进行卡方检验和Fisher精确检验。

结果

84例患者被随机分配使用低粘度(n = 42)或高粘度(n = 42)OCA组织粘合剂。两组患者的基线特征和伤口特征相似。高粘度OCA比低粘度制剂迁移的可能性更小(21%对78%,p < 0.001;优势比 = 0.3,95%置信区间 = 0.1至0.5)。高粘度组在应用OCA期间感觉到热的患者比例更高(分别为44%对26%,p = 0.11);然而,两组中所有有这种感觉的患者都愿意再次使用该装置。在14天时,两组均无伤口感染。高粘度组有1例伤口裂开。

结论

高粘度OCA组织粘合剂比低粘度装置迁移的可能性更小。两个治疗组的伤口裂开和感染率都低至可接受水平。

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