Elsevier

The Lancet

Volume 382, Issue 9898, 28 September–4 October 2013, Pages 1105-1112
The Lancet

Articles
Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: a phase 3, multicentre, open-label, randomised controlled trial

https://doi.org/10.1016/S0140-6736(13)61780-8Get rights and content

Summary

Background

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.

Methods

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.

Findings

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).

Interpretation

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.

Funding

Johnson & Johnson.

Introduction

Wound complications are among the most common issues reported after surgery, and are often very problematic for patients in terms of cosmetic appearance, decreased quality of life, prolonged hospital stays, and increased health-care costs.1, 2 Several publications have addressed ways to reduce the risk of wound complications associated with surgery,3, 4, 5, 6 such as intraoperative administration of antimicrobial prophylaxis,4, 5 skin preparation, barrier retractional wound protection,7 use of absorbable sutures during intraperitoneal procedures,8, 9 and pulsatile lavage irrigation of wounds before closure.10, 11 Triclosan-coated sutures significantly reduced the rate of surgical site infections compared with conventional uncoated sutures in various types of surgery.12

Because of the increase in the number of patients with preoperative comorbidities that are risk factors for wound complications, such as malnutrition,13 diabetes mellitus,14 and obesity,15 new, innovative approaches will be necessary to decrease the risk of wound complications after surgery. Subcuticular suturing for skin closure is an attractive alternative for skin approximation in most types of surgery. It is often used in plastic surgery because of the low incidence of wound complications and good cosmetic appearance.16, 17, 18 Compared with staples, several clinical trials have shown that subcuticular sutures are associated with a significantly lower incidence of wound complications and better cosmetic results after orthopaedic surgery,19 cardiovascular surgery,20, 21 and caesarean section.22, 23

In 242 patients undergoing coronary artery bypass graft surgery, Johnson and colleagues24 prospectively closed half of each sternal and saphenous vein harvest wound with staples and half with intradermal sutures. The incidence of wound infection was similar with both methods, but significantly fewer wound complications were noted with subcuticular sutures than with staples. Additionally, patients who expressed a preference preferred sutures to staples. Basha and investigators25 randomly assigned 435 patients undergoing caesarean delivery to stainless steel staples or subcuticular 4-0 monocryl sutures. They reported that staple closure was associated with a four-times increased risk of wound separation (adjusted odds ratio [OR] 4·66, 95% CI 2·07–10·52; p<0·001) and poor patient satisfaction.

These trials had been done for class 1 surgical procedures—ie, clean surgery. However, the benefit of subcuticular sutures in gastrointestinal surgery, a class 2 (clean-contaminated) surgery that is associated with a high incidence of wound complications,15, 26, 27 has not been fully examined.28 Staples are the most commonly used technique for skin closure during gastrointestinal surgery because of convenience and speed. Because no consensus has been reached about how to apply findings from class 1 surgery to class 2 surgery, an optimum method of skin for gastrointestinal surgery remains to be established.

We investigated differences in prevention of wound complications between subcuticular sutures and staples after elective upper and lower gastrointestinal open surgery.

Section snippets

Study design and participants

We did a large-scale, multicentre, open-label, phase 3 randomised controlled trial at 24 institutions in Japan from June 1, 2009, to Feb 28, 2012. The study was organised by the Clinical Study Group of Osaka University on Risk Management (OSGO-RM), which is composed of hospitals affiliated from the Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University.

Eligible patients were undergoing elective upper or lower gastrointestinal surgery, aged 20 years or older,

Results

Figure 1 shows the trial profile. 1080 patients from 24 institutions were enrolled and randomly assigned—562 to subcuticular sutures and 518 to staples. Assessment of case report forms showed that four patients in each group were ineligible for inclusion, and thus the modified intention-to-treat population comprised 558 patients in the subcuticular sutures group and 514 in the staples group (figure 1). Ten patients in the subcuticular sutures group and three in the staples group needed

Discussion

Subcuticular sutures for skin closure have been advocated instead of staples in clean (class 1) surgery, including cardiovascular surgery,24 orthopaedic surgery,19 and caesarean delivery,25 on the basis of the results of randomised studies. Whether these results can be applied to class 2 surgery, as represented by gastrointestinal surgery, is of concern. Classification of the types of surgery is described in panel 1. Our results show that subcuticular sutures did not significantly reduce the

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