Effect of Single-Dose Prophylactic Ampicillin and Sulbactam on Wound Infection After Tension-Free Inguinal Hernia Repair With Polypropylene Mesh: The Randomized, Double-Blind, Prospective Trial
Effect of Single-Dose Prophylactic Ampicillin and Sulbactam on Wound Infection After Tension-Free Inguinal Hernia Repair With Polypropylene Mesh: The Randomized, Double-Blind, Prospective Trial
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DOI：
10.1097/00000658-200101000-00005
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发表时间：
2001-01
影响因子：
9
通讯作者：
M. Yerdel;E. B. Akin;Sukru Dolalan;A. Turkcapar;M. Pehlivan;I. Gecim;E. Kuterdem
中科院分区：
文献类型：
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作者：
M. Yerdel;E. B. Akin;Sukru Dolalan;A. Turkcapar;M. Pehlivan;I. Gecim;E. Kuterdem
目的通过一项双盲、前瞻性、随机试验，评价单剂量、静脉预防性氨苄西林舒巴坦（AS）在开放式腹股沟疝修复术中预防伤口感染的价值。背景资料在开放式腹股沟疝假体手术中抗生素预防的使用是有争议的，没有前瞻性试验来研究这个问题。方法选择行聚丙烯补片Lichtenstein技术单侧原发性腹股沟疝选择性修补术的患者，随机分为切开前静脉注射1.5 g AS或等量安慰剂两组。复发性、股疝、双侧、巨大疝或嵌顿疝或任何全身性疾病的患者均被排除在外。记录年龄、性别、体重指数、美国麻醉医师学会评分、疝气类型、麻醉类型、手术持续时间和引流管使用情况。感染是根据疾病控制中心的标准定义的。术后1周、1个月、6个月和1年由独立外科医生对患者进行评估。记录所有并发症。使用卡方检验、Fisher精确检验和学生t检验对结果进行评估。结果1996年9月至1998年7月，280例患者（140例AS组，140例安慰剂组）进入该方案。AS组的4名患者和安慰剂组的7名患者因意外使用抗生素或随访问题而被排除。各组在所有研究变量和术后并发症（不包括伤口感染）方面匹配良好，AS组伤口感染发生率为0.7%，安慰剂组为9% （P = 0.00153）。安慰剂组的12名患者出现了伤口感染，其中3名患者需要5次重复住院。这三名患者的移植物受到了深度感染，其中两名患者的移植物丢失。AS组的单个感染患者也因深度持续感染而切除了移植物。结论：本研究表明，在利希滕斯坦疝修补术中，单剂量静脉注射AS可显著降低（10倍）整体伤口感染。使用AS也减少了深部感染和伤口感染相关的再入院。因此，根据本试验的结果，可能建议补片修复的支持者使用预防性单剂量静脉注射抗生素。AS被证明是一种有效的抗菌剂。
ObjectiveTo assess the value of single-dose, intravenous, prophylactic ampicillin and sulbactam (AS) in the prevention of wound infections during open prosthetic inguinal hernia repair by a double-blind, prospective, randomized trial. Summary Background DataThe use of antibiotic prophylaxis during open prosthetic inguinal hernia surgery is controversial, and no prospective trial has been conducted to examine this issue. MethodsPatients undergoing unilateral, primary inguinal hernia repair electively with the Lichtenstein technique using polypropylene mesh were randomized to receive 1.5 g intravenous AS before the incision or an equal volume of placebo according to a predetermined code of which the surgeons were unaware. Patients with recurrent, femoral, bilateral, giant, or incarcerated hernias or any systemic diseases were excluded. Age, sex, body mass index, American Society of Anesthesiologists score, type of hernia, type of anesthesia, duration of surgery, and use of drains were recorded. Infection was defined according to the criteria of Centers for Disease Control. Patients were evaluated 1 week, 1 month, 6 months, and 1 year after surgery by an independent surgeon. All complications were recorded. Results were assessed using chi-square, Fisher’s exact, and Student t tests as appropriate. ResultsBetween September 1996 and July 1998, 280 patients (140 AS, 140 placebo group) entered the protocol. Four patients from the AS group and seven from the placebo group were excluded because of inadvertent antibiotic administration or follow-up problems. Groups were well matched for all the variables studied and postoperative complications, excluding wound infections, which occurred at a rate of 0.7% in the AS group and 9% in the placebo group (P = .00153). Twelve patients in the placebo group developed wound infections, requiring five repeat hospital admissions in three patients. These three patients suffered deep infections reaching the graft, which resulted in graft loss in two. The single infected patient in the AS group had his graft removed as well because of deep persistent infection. ConclusionsThis study documented a significant (10-fold) decrease in overall wound infections when single-dose, intravenous AS was used during Lichtenstein hernia repair. Deep infections and wound infection-related readmissions were also reduced by the use of AS. Proponents of mesh repairs may therefore be advised to use prophylactic single-dose intravenous antibiotic coverage in the light of the results of this trial. AS proved to be an effective antimicrobial agent.