Beam Joel W
University of North Florida, Brooks College of Health, Athletic Training/Physical Therapy Department, Jacksonville, FL 32224-2673, USA.
J Athl Train. 2008 Apr-Jun;43(2):222-4. doi: 10.4085/1062-6050-43.2.222.
REFERENCE/CITATION: Farion K, Osmond MH, Hartling L, et al. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2001(4);CD003326.
What is the clinical evidence base for tissue adhesives in the management of simple traumatic lacerations?
Studies were identified by searches of the following databases: Cochrane Wounds Group Specialized Trials Register (September 2003), Cochrane Central Register of Controlled Trials (CENTRAL) (CDROM 2003, issue 3), MEDLINE (1966 to September 2003, week 1), EMBASE (1988 to 2003, week 36), Web of Science Science Citation Index (1975 to September 13, 2003) and various clinical trials registers (September 2003). Investigators and product manufacturers were contacted to identify additional eligible studies. The search terms included wounds and injuries, laceration, face injury, nose injury, tissue adhesives, and acrylates.
Each study fulfilled the following criteria: (1) The study was a randomized controlled trial that compared tissue adhesives with standard wound closure (SWC) (sutures, staples, adhesive strips) or tissue adhesive with tissue adhesive. (2) The wounds were acute, linear lacerations less than 12 hours old, resulting from blunt or sharp trauma. (3) The wound length, width, and depth allowed for approximation of the edges with minimal tension after deep sutures were placed, if required. Studies were included with no language or publication status restriction, with participants of any age recruited in an emergency department, outpatient clinic, walk-in clinic, or other primary care setting. Studies were excluded if the wounds were stellate lacerations, puncture wounds, mammalian bites, infected, heavily contaminated or devitalized, crossing joints or mucocutaneous junctions, in hair-bearing areas, or in patients with keloid formation or chronic illness.
The characteristics of the study and participants, interventions, outcome measures, and findings were extracted by one author and verified by a second using a standard form. The primary measure was cosmetic outcome. Secondary measures were pain with the procedure, time to complete the procedure, and complications (erythema, infection, discharge, need for delayed closure, and dehiscence). Studies were divided into 2 groups as follows: group 1, comparisons among tissue adhesives with SWC, and group 2, comparisons among different tissue adhesives. All eligible studies were assessed for methodologic quality independently by 2 investigators using the Jadad Scale, which evaluates randomization, double blinding, withdrawals, and dropouts and is scored on a 5-point (maximum) scale. The data from the tissue adhesive and SWC studies were pooled and analyzed with a random-effects model. The I (2) statistic was used to determine heterogeneity among the studies. chi (2) analysis was performed to compare participant age, wound location, and type of tissue adhesive among the studies. The data from the studies comparing tissue adhesives were pooled and analyzed using a fixed-effects model.
The search criteria identified 39 eligible studies, of which 11 met the inclusion criteria. In 10 studies, a tissue adhesive was compared with SWC. Five groups used butylcyanoacrylate, and 5 used octylcyanoacrylate. For SWC, 6 groups used sutures, 2 used adhesive strips, and 2 used a combination of methods, although most used sutures. Six studies were limited to pediatric patients and 2 to adult patients; 2 included patients of any age. Wounds were limited to facial lacerations in 2 pediatric studies and 1 group with patients of any age. Lacerations requiring deep sutures were excluded in 4 studies. One group compared tissue adhesives (butylcyanoacrylate and octylcyanoacrylate) among pediatric patients with facial lacerations not requiring deep sutures. In the 11 included studies, authors of 9 randomized and evaluated 1 laceration per patient, whereas 2 groups included patients with more than 1 laceration. In 1 group, each laceration was independently randomized and evaluated, and the other group randomized the patient and assigned all lacerations to a treatment group (tissue adhesive with SWC or tissue adhesive with tissue adhesive). The sample sizes ranged between 60 and 163 lacerations, and all 11 studies were performed in emergency departments. The primary measure in all included studies was cosmetic outcome. The majority of groups used the Cosmetic Visual Analogue Scale, the Wound Evaluation Score, or a combination of these measures. Three groups measured cosmetic outcome with nonvalidated scoring systems. Assessment time periods were grouped and reported at (1) 5 to 14 days, (2) 1 to 3 months, and (3) 9 to 12 months after wound closure. Secondary outcomes were pain (as noted on visual analogue scale) and time to complete the procedure (as mean number of minutes). The 11 studies scored from 1 to 3 on the Jadad Scale. Adequate allocation concealment was reported in only 1 group. Examining cosmetic outcome, 8 groups (565 lacerations) used the Cosmetic Visual Analogue Scale to compare tissue adhesives and SWC. The authors reported no significant differences in scores at the time periods of 5 to 14 days, 1 to 3 months, and 9 to 12 months. A subgroup analysis showed a significant ( P = .005) superiority of butylcyanoacrylate over SWC at 1 to 3 months. Using the Wound Evaluation Score, 4 studies (364 lacerations) compared tissue adhesives with SWC. No significant differences in cosmetic scores were found at 5 to 14 days, 1 to 3 months, or 9 to 12 months. One group (83 lacerations) compared butylcyanoacrylate with octylcyanoacrylate and reported no significant differences in cosmetic scores using the Cosmetic Visual Analogue Scale at 1 to 3 months and the Wound Evaluation Score at 5 to 14 days and 1 to 3 months. Examining secondary outcomes, 6 groups (570 lacerations) compared tissue adhesives with SWC using the visual analogue scale for pain. Scores reported by parents, patients, physicians, and nurses significantly favored tissue adhesives. In 6 studies (584 lacerations), tissue adhesives were significantly favored over SWC in time to complete the procedure. For complication outcomes, 8 groups (727 lacerations) demonstrated significantly fewer incidences of erythema and an increased risk of dehiscence with tissue adhesives compared with SWC. No significant differences were shown for infection, delayed closure, or discharge. Among 83 lacerations, 1 group compared butylcyanoacrylate with octylcyanoacrylate and reported no significant differences in combined patient-reported and parent-reported visual analogue pain scores, time to complete the procedure, dehiscence, or infection.
This review provides evidence that tissue adhesives are an option to SWC (sutures, staples, adhesive strips) for the management of simple traumatic lacerations. Overall, no significant differences were found in cosmetic scores at the reported assessment periods between tissue adhesives and SWC. At 1 to 3 months, a subgroup analysis significantly favored butylcyanoacrylate over SWC. Tissue adhesives significantly lowered the time to complete the procedure, levels of pain, and rate of erythema. However, the data revealed a significant increase in the rate of dehiscence with the use of tissue adhesives when compared with SWC. The low methodologic quality of the evidence should be considered in the interpretation of the findings.
参考文献/引用文献:法里翁K、奥斯蒙德MH、哈特林L等。儿童和成人创伤性撕裂伤的组织粘合剂。考科蓝系统评价数据库。2001年第4期;CD003326。
在单纯性创伤性撕裂伤的处理中,组织粘合剂的临床证据基础是什么?
通过检索以下数据库确定研究:考科蓝伤口小组专业试验注册库(2003年9月)、考科蓝对照试验中心注册库(CENTRAL)(2003年光盘版,第3期)、医学索引数据库(1966年至2003年9月第1周)、荷兰医学文摘数据库(1988年至2003年第36周)、科学网科学引文索引(1975年至2003年9月13日)以及各种临床试验注册库(2003年9月)。联系了研究人员和产品制造商以确定其他符合条件的数据。检索词包括伤口与损伤、撕裂伤、面部损伤、鼻部损伤、组织粘合剂和丙烯酸酯。
每项研究均符合以下标准:(1)该研究为随机对照试验,比较了组织粘合剂与标准伤口闭合方法(SWC,缝线、吻合钉、粘合带)或组织粘合剂与组织粘合剂。(2)伤口为急性、线性撕裂伤,受伤时间小于12小时,由钝性或锐性创伤引起。(3)伤口的长度、宽度和深度允许在必要时放置深部缝线后以最小张力对合边缘。纳入的研究不受语言或发表状态限制,参与者为在急诊科、门诊诊所、随诊诊所或其他初级保健机构招募的任何年龄患者。如果伤口为星芒状撕裂伤、刺伤、哺乳动物咬伤、感染、严重污染或失活、跨越关节或粘膜皮肤交界处、在有毛发区域或患有瘢痕疙瘩形成或慢性病的患者中,则排除该研究。
由一位作者提取研究及参与者的特征、干预措施、结局指标和研究结果,并由另一位作者使用标准表格进行核实。主要指标为美容效果。次要指标为操作时的疼痛、完成操作的时间以及并发症(红斑、感染、渗出、延迟闭合的必要性和裂开)。研究分为以下两组:第1组,组织粘合剂与SWC的比较;第2组,不同组织粘合剂之间的比较。由2名研究人员使用Jadad量表独立评估所有符合条件研究的方法学质量,该量表评估随机化、双盲、撤稿和失访情况,并以5分(满分)评分。将组织粘合剂和SWC研究的数据合并,并用随机效应模型进行分析。I(2)统计量用于确定研究之间的异质性。进行卡方分析以比较研究之间的参与者年龄、伤口位置和组织粘合剂类型。将比较组织粘合剂的研究数据合并,并用固定效应模型进行分析。
检索标准确定了39项符合条件的研究,其中11项符合纳入标准。在10项研究中,将一种组织粘合剂与SWC进行了比较。5组使用丁基氰基丙烯酸酯,5组使用辛基氰基丙烯酸酯。对于SWC,6组使用缝线,2组使用粘合带,2组使用多种方法组合,尽管大多数使用缝线。6项研究仅限于儿科患者,2项仅限于成人患者;2项纳入了任何年龄的患者。2项儿科研究和1组任何年龄患者的研究中,伤口仅限于面部撕裂伤。4项研究排除了需要深部缝线的撕裂伤。一组比较了儿科面部撕裂伤且不需要深部缝线患者中组织粘合剂(丁基氰基丙烯酸酯和辛基氰基丙烯酸酯)。在11项纳入研究中,9项研究的作者对每位患者的1处撕裂伤进行随机分组和评估,而2组纳入了多处撕裂伤的患者。在一组中,对每处撕裂伤进行独立随机分组和评估,另一组对患者进行随机分组并将所有撕裂伤分配至一个治疗组(组织粘合剂与SWC或组织粘合剂与组织粘合剂)。样本量在60至163处撕裂伤之间,所有11项研究均在急诊科进行。所有纳入研究的主要指标为美容效果。大多数组使用美容视觉模拟量表、伤口评估评分或这些指标的组合。3组使用未经验证的评分系统测量美容效果。评估时间段分为并报告为(1)伤口闭合后5至14天,(2)1至3个月,(3)9至12个月。次要结局为疼痛(如视觉模拟量表所示)和完成操作的时间(以平均分钟数表示)。11项研究在Jadad量表上的评分在1至3分之间。仅1组报告了充分的分配隐藏。在检查美容效果方面,8组(565处撕裂伤)使用美容视觉模拟量表比较组织粘合剂和SWC。作者报告在5至14天、1至3个月和9至12个月时评分无显著差异。亚组分析显示在1至3个月时丁基氰基丙烯酸酯优于SWC(P = 0.005)。使用伤口评估评分,4项研究(364处撕裂伤)比较了组织粘合剂与SWC。在5至14天、1至3个月或9至12个月时,美容评分无显著差异。一组(83处撕裂伤)比较了丁基氰基丙烯酸酯与辛基氰基丙烯酸酯,报告在1至3个月时使用美容视觉模拟量表以及在5至14天和1至3个月时使用伤口评估评分的美容评分无显著差异。在检查次要结局方面,6组(570处撕裂伤)使用疼痛视觉模拟量表比较组织粘合剂与SWC。家长、患者、医生和护士报告的评分显著支持组织粘合剂。在6项研究(584处撕裂伤)中,组织粘合剂在完成操作的时间上显著优于SWC。对于并发症结局,8组(727处撕裂伤)表明与SWC相比,组织粘合剂的红斑发生率显著降低,但裂开风险增加。在感染、延迟闭合或渗出方面未显示显著差异。在83处撕裂伤中,一组比较了丁基氰基丙烯酸酯与辛基氰基丙烯酸酯,报告在患者和家长联合报告的视觉模拟疼痛评分、完成操作的时间、裂开或感染方面无显著差异。
本综述提供的证据表明,在单纯性创伤性撕裂伤的处理中,组织粘合剂是SWC(缝线、吻合钉、粘合带)的一种选择。总体而言,在报告的评估时间段内,组织粘合剂和SWC的美容评分无显著差异。在1至3个月时,亚组分析显著显示丁基氰基丙烯酸酯优于SWC。组织粘合剂显著缩短了完成操作的时间、降低了疼痛程度和红斑发生率。然而,数据显示与SWC相比,使用组织粘合剂时裂开发生率显著增加。在解释研究结果时应考虑证据的低方法学质量。