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Multicenter Double-Blinded Randomized Controlled Trial of Standard Abdominal Wound Edge Protection With Surgical Dressings Versus Coverage With a Sterile Circular Polyethylene Drape for Prevention of Surgical Site Infections: A CHIR-Net Trial (BaFO; NCT01181206)

Mihaljevic, André L. MD*; Schirren, Rebekka MD*; Özer, Mine MD*; Ottl, Stephanie MD*; Grün, Sybille CNS*; Michalski, Christoph W. MD*; Erkan, Mert MD*; Jäger, Carsten MPH*; Reiser-Erkan, Carolin MD*; Kehl, Victoria PhD; Schuster, Tibor PhD; Roder, Jürgen MD; Clauer, Ulf MD; Orlitsch, Carolin MD§; Hoffmann, Tomas F. MD§; Lange, Reinhard MD; Harzenetter, Thomas MD; Steiner, Phillip MD; Michalski, Milena MD; Henkel, Karl MD**; Stadler, Josef MD**; Pistorius, Georg A. MD††; Jahn, Anja MD††; Obermaier, Robert MD‡‡; Unger, Robert MD‡‡; Strunk, Roland MD§§; Willeke, Frank MD§§; Vogelsang, Holger MD¶¶; Halve, Bert MD¶¶; Dietl, Karl-Heinz MD‖‖; Hilgenstock, Hendrik MD***; Meyer, Alexander MD***; Krämling, Hans-Jörg MD†††; Wagner, Markus MD‡‡‡; Schoenberg, Michael H. MD‡‡‡; Zeller, Florian MD§§§; Schmidt, Johannes MD¶¶¶; Friess, Helmut MD*; Kleeff, Jörg MD*

doi: 10.1097/SLA.0000000000000954
Papers of the 21st Annual ESA Meeting

Objective: To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy.

Background: SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of the most frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs.

Methods: In this randomized controlled, multicenter, 2-arm, parallel-group design, patient- and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period.

Results: Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n = 9; intervention, n = 9) and death (control, n = 4; intervention, n = 7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio = 0.462, 95% confidence interval: 0.281–0.762; P = 0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in clean-contaminated/contaminated surgeries.

Conclusions: Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery.

Supplemental Digital Content is Available in the Text.In this randomized controlled, multicenter, patient- and observer-blinded trial, we studied the effect of circular wound edge protectors on surgical site infections (SSIs) in open elective abdominal surgery. We found a significant reduction in SSI rate with 27 out of 274 patients (9.9%) in the device group and 52 out of 272 patients (19.1%) in the control group (odds ratio = 0.462, 95% confidence interval: 0.281–0.762; P = 0.002) experiencing an SSI within a 45-day postoperative period. Subgroup analysis revealed that the effect might be more pronounced in colorectal surgery.

*Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Ismaningerstraße 22, 81675 Munich, Germany and CHIR-Net Munich

Institute for Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Ismaningerstraße 22, 81675 Munich, Germany

Department of Surgery, Kreisklinik Altötting, Vinzenz-von-Paul Straße 10, 84503 Altötting, Germany

§Department of Surgery, Maria-Theresia-Klinik, Bavariaring 46, 80336 Munich, Germany

Department of Surgery, Ilmtalklinik GmbH Pfaffenhofen, Krankenhausstraße 70, 85276 Pfaffenhofen, Germany

Department of Surgery, Klinikum Bogenhausen, Englschalkinger Straße 77, 81925 Munich, Germany

**Department of Surgery, Romed Klinikum Prien am Chiemsee, Harrasser Straße 61-63 83209 Prien, Germany

††Department of Surgery, Sozialstiftung Bamberg, Klinikum am Bruderwald, Buger Straße 80, 96049 Bamberg, Germany

‡‡Department of Surgery, Klinikum St Elisabeth Straubing GmbH, St-Elisabeth-Straße 23, 94315 Straubing, Germany

§§Department of Surgery, St Marienkrankenhaus GmbH, Kampenstraße 51, 57072 Siegen, Germany

¶¶Department of Surgery, Klinikum Garmisch-Partenkirchen, Auenstraße 6, 82467 Garmisch-Partenkirchen, Germany

‖‖Department of Surgery, Kliniken Nordoberpfalz AG, Klinikum Weiden, Söllnerstraße 16, 92637 Weiden, Germany

***Johanniter-Krankenhaus Rheinhausen GmbH, Kreuzacker 1-7, 47228 Duisburg, Germany

†††Department of Surgery, Evangelisches Krankenhaus Düsseldorf, Kirchfeldstraße 40, 40217 Düsseldorf, Germany

‡‡‡Department of Surgery, Rotkreuzklinikum München, Nymphenburger Straße 163, 80634 Munich, Germany

§§§Department of Surgery, Klinikum Freising GmbH, Alois-Steinecker-Straße 18, 85356 Freising, Germany

¶¶¶Department of Surgery, Krankenhaus Landshut-Achdorf, Achdorfer Weg 3, 84036 Landshut, Germany.

Reprints: Jörg Kleeff, MD, Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Ismaningerstraße 22, 81675 Munich, Germany. E-mail: joerg.kleeff@tum.de.

Disclosure: The Surgical Trial Network CHIR-Net is funded by the German Ministry of Research and Education [Bundesministerium für Bildung und Forschung (BMBF); 01GH0702]. The Münchner Studienzentrum, responsible for monitoring and data management, is funded by the BMBF (01KN1104). The circular polyethylene wound protector (Steri-Drape Wound Edge Protector) was provided by 3M Infection Prevention Division (3M Medica, 3M Deutschland GmbH, 41453 Neuss). No financial support was given other than the funding by the BMBF mentioned earlier. There are no restrictions on publications and no conflicts of interest. The idea for the BaFO trial was conceived, the trial protocol written, and the trial initiated independent of any industrial funder. Industrial funders and trial management are independent. F.W. received lecture payments from the following companies: Aesculap, Bayer, Covidien, and Wolf for lectures given on laparoscopic surgery and deep venous thrombosis prophylaxis. All other authors reported no conflicts of interest. No funding was received from any of the following institutions: National Institutes of Health (NIH); Wellcome Trust; Howard Hughes Medical Institute (HHMI). The authors declare no conflicts of interest.

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© 2014 by Lippincott Williams & Wilkins.