Department of Surgery, Kaizuka City Hospital, Osaka, Japan.
Lancet. 2013 Sep 28;382(9898):1105-12. doi: 10.1016/S0140-6736(13)61780-8.
Staples have been widely used for skin closure after open gastrointestinal surgery. The potential advantages of subcuticular sutures compared with staples have not been assessed. We assessed the differences in the frequency of wound complications, including superficial incisional surgical site infection and hypertrophic scar formation, depending on whether subcuticular sutures or staples are used.
We did a multicentre, open-label, randomised controlled trial at 24 institutions between June 1, 2009, and Feb 28, 2012. Eligible patients aged 20 years or older, with adequate organ function and undergoing elective open upper or lower gastrointestinal surgery, were randomly assigned preoperatively to either staples or subcuticular sutures for skin closure. Randomisation was done via a computer-generated permuted-block sequence, and was stratified by institution, sex, and type of surgery (ie, upper or lower gastrointestinal surgery). Our primary endpoint was the incidence of wound complications within 30 days of surgery. Analysis was done by intention to treat. This study is registered with UMINCTR, UMIN000002480.
1080 patients were enrolled and randomly assigned in a one to one ratio: 562 to subcuticular sutures and 518 to staples. 1072 were eligible for the primary endpoint and 1058 for the secondary endpoint. Of the 558 patients who received subcuticular sutures, 382 underwent upper gastrointestinal surgery and 176 underwent lower gastrointestinal surgery. Wound complications occurred in 47 of 558 patients (8·4%, 95% CI 6·3-11·0). Of the 514 who received staples, 413 underwent upper gastrointestinal surgery and 101 underwent lower gastrointestinal surgery. Wound complications occurred in 59 of 514 (11·5%, 95% CI 8·9-14·6). Overall, the rate of wound complications did not differ significantly between the subcuticular sutures and staples groups (odds ratio 0·709, 95% CI 0·474-1·062; p=0·12).
The efficacy of subcuticular sutures was not validated as an improvement over a standard procedure for skin closure to reduce the incidence of wound complications after open gastrointestinal surgery.
Johnson & Johnson.
在开放式胃肠外科手术后，缝线已被广泛用于皮肤缝合。与缝线相比，皮下缝合具有潜在的优势，但尚未对此进行评估。我们评估了不同的皮肤缝合方式（缝线或订书钉）对伤口并发症（包括切口感染和增生性瘢痕形成）的影响。
我们在 2009 年 6 月 1 日至 2012 年 2 月 28 日期间在 24 家机构进行了一项多中心、开放性、随机对照试验。纳入年龄在 20 岁及以上、器官功能良好且接受择期开放式上消化道或下消化道手术的患者，在术前随机分为缝线或订书钉组进行皮肤缝合。随机分组通过计算机生成的随机分组序列进行，按机构、性别和手术类型（即上消化道或下消化道手术）分层。我们的主要终点是术后 30 天内的伤口并发症发生率。分析采用意向治疗。本研究在日本 UMINCTR 注册，注册号为 UMIN000002480。
共纳入 1080 例患者，按 1:1 比例随机分配：562 例接受缝线，518 例接受订书钉。1072 例患者符合主要终点纳入标准，1058 例患者符合次要终点纳入标准。在接受缝线的 558 例患者中，382 例行上消化道手术，176 例行下消化道手术。558 例患者中，有 47 例（8.4%，95%CI 6.3-11.0）发生伤口并发症。接受订书钉的 514 例患者中，413 例行上消化道手术，101 例行下消化道手术。514 例患者中，有 59 例（11.5%，95%CI 8.9-14.6）发生伤口并发症。总体而言，缝线组和订书钉组的伤口并发症发生率无显著差异（比值比 0.709，95%CI 0.474-1.062；p=0.12）。
在开放式胃肠外科手术后，与标准皮肤缝合术相比，皮下缝线并未被证实能降低伤口并发症的发生率，因此不能作为一种有效的治疗方法。
Johnson & Johnson。
