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Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial

  • Original Article
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Journal of Gastrointestinal Surgery Aims and scope

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Abstract

Background

The incisional surgical site infection (SSI) is an extremely common complication following open abdominal surgery and imposes a considerable treatment and cost burden.

Method

We conducted a multicenter open-label randomized controlled trial at three Tokyo Metropolitan medical institutions. We enrolled adult patients who underwent either an elective or an emergency open laparotomy. Eligible patients were allocated preoperatively to undergo wound closure with either subcuticular sutures or staples. A central Web-based randomization tool was used to assign participants randomly by a permuted block sequence with a 1:1 allocation ratio and a block size of 4 before mass closure to each group. The primary endpoint was the occurrence of a superficial SSI within 30 days after surgery in accordance with the Centers for Disease Control and Prevention criteria. This trial was registered with UMIN-CTR as UMIN 000004836 (http://www.umin.ac.jp/ctr).

Results

Between September 1, 2010 and August 31, 2015, 401 patients were enrolled and randomly assigned to either group. One hundred and ninety-nine patients were allocated to the subcuticular suture and 202 patients to the staple groups (hereafter the “suture” and “staple” group, respectively). Three hundred and ninety-nine were eligible for the primary endpoint. Superficial SSIs occurred in 25 of 198 suture patients and in 27 of 201 staple patients. Overall, the rate of superficial SSIs did not differ significantly between the suture and staple groups.

Conclusion

Subcuticular sutures did not increase the occurrence of superficial SSIs following open laparotomies mainly consisting of clean-contaminated surgical procedures. The applicability of the wound closure material and method is likely to depend on individual circumstances of the patient and surgical procedure.

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Acknowledgments

This study was supported by the Clinical Research Fund of Tokyo Metropolitan Government. We thank Ms. Mio Yatsuhashi, Ms. Takako Miyazaki, and Ms. Akemi Masuda of the Data Center at TMTMC for collecting the data. We are also grateful to the kind support of Ms. Masako Tomotsune, coordinator of clinical research at TMCMC.

Authors’ Contributions

KA and KI drafted the paper. SM and KI designed the protocol. MM supervised the design of the trial and assisted with conducting the trial. KI, KA, SS, and YS obtained and analyzed the data. KI, RS, and KA were the main investigators. All other authors participated in study execution and recruitment of patients. YM and TK provided expertise in statistical analysis and interpretation.

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    Authors and Affiliations

    1. Department of Surgery, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan

      Kazuhiro Imamura, Kensuke Adachi, Ritsuko Sasaki & Satoko Monma

    2. Department of Surgery, Ebara Hospital, Tokyo Metropolitan Health and Medical Corporation, 4-5-10 Higashi-Yukigaya, Ohta-ku, Tokyo, 145-0065, Japan

      Kensuke Adachi

    3. Department of Surgery, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan

      Sadaaki Shioiri

    4. Department of Surgery, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan

      Yasuji Seyama

    5. Department of Clinical Research Support Center, Tokyo Metropolitan Children’s Medical Center, Tokyo, Japan

      Masaru Miura, Yoshihiko Morikawa & Tetsuji Kaneko

    Authors
    1. Kazuhiro Imamura
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    Corresponding author

    Correspondence to Kensuke Adachi.

    Ethics declarations

    This study protocol was approved by the institutional review boards of all the participating hospitals. All patients provided written informed consent before participation.

    Conflicts of Interest

    The authors declare that they have no conflicts of interest.

    Funding

    Research Grant of the Tokyo Metropolitan Government.

    Additional information

    Kazuhiro Imamura and Kensuke Adachi contributed equally to this work.

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    Imamura, K., Adachi, K., Sasaki, R. et al. Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial. J Gastrointest Surg 20, 2083–2092 (2016). https://doi.org/10.1007/s11605-016-3283-z

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    • DOI: https://doi.org/10.1007/s11605-016-3283-z

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