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一项关于新型伤口闭合薄膜与皮肤缝线用于手术伤口闭合的前瞻性、随机、盲法研究。

Prospective, randomized, blinded study of a new wound closure film versus cutaneous suture for surgical wound closure.

作者信息

Kuo Felix, Lee Dennis, Rogers Gary S

机构信息

Department of Dermatology, Boston University School of Medicine, Boston, Massachusetts 02111, USA.

出版信息

Dermatol Surg. 2006 May;32(5):676-81. doi: 10.1111/j.1524-4725.2006.32140.x.

DOI:10.1111/j.1524-4725.2006.32140.x
PMID:16706763
Abstract

BACKGROUND

Wound closure devices include sutures, tissue adhesives, adhesive strips, and staples. Recent studies suggest no differences between various tissue adhesives and sutures for dehiscence, infection, and satisfaction when assessed by patients or surgeons. To date, no studies have investigated ClozeX, a novel adhesive strip, for closure of surgical incisions.

OBJECTIVE

To compare surgical wounds repaired with ClozeX versus suture.

METHODS

A prospective, randomized study was conducted, in which 15 patients with surgical incisions were allocated to closure with ClozeX on half of the wound and monofilament suture on the other half. Physician satisfaction with blinded assessment, patient satisfaction, complication rates, and closure times were recorded.

RESULTS

Application with ClozeX was faster than with suture (p=.007). There were no complications in either group. Sixty-nine percent of the patients gave ClozeX a higher satisfaction score (p=.02). More physicians were satisfied with the ClozeX half than with the suture half (p=.007).

CONCLUSIONS

This pilot study demonstrates ClozeX to be a safe and effective closure device. The cosmetic outcome seems to be at least as good as simple running suture. Physicians and patients were generally more satisfied with ClozeX. No difference was found in the rate of dehiscence or infection between the groups.

摘要

背景

伤口闭合装置包括缝线、组织粘合剂、粘合带和吻合钉。最近的研究表明,在患者或外科医生评估时,各种组织粘合剂和缝线在伤口裂开、感染及满意度方面并无差异。迄今为止,尚无研究调查新型粘合带ClozeX用于手术切口闭合的情况。

目的

比较使用ClozeX与缝线修复手术伤口的效果。

方法

进行了一项前瞻性随机研究,15例有手术切口的患者被分配为一半伤口用ClozeX闭合,另一半用单丝缝线闭合。记录医生对盲法评估的满意度、患者满意度、并发症发生率及闭合时间。

结果

使用ClozeX比使用缝线更快(p = 0.007)。两组均无并发症。69%的患者对ClozeX给出更高的满意度评分(p = 0.02)。更多医生对使用ClozeX的那一半伤口比使用缝线的那一半更满意(p = 0.007)。

结论

这项初步研究表明ClozeX是一种安全有效的闭合装置。其美容效果似乎至少与简单连续缝线一样好。医生和患者总体上对ClozeX更满意。两组之间在伤口裂开或感染率方面未发现差异。

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