Markus K Diener1, Phillip Knebel2, Meinhard Kieser3, Philipp Schüler4, Tobias S Schiergens5, Vladimir Atanassov6, Jens Neudecker7, Erwin Stein8, Henryk Thielemann9, Reiner Kunz10, Moritz von Frankenberg11, Utz Schernikau12, Jörg Bunse13, Boris Jansen-Winkeln14, Lars I Partecke15, Gerald Prechtl16, Julius Pochhammer17, Ralf Bouchard18, René Hodina19, K Tobias E Beckurts20, Lothar Leißner21, Hans-Peter Lemmens22, Friedrich Kallinowski23, Oliver Thomusch24, Daniel Seehofer25, Thomas Simon26, Alexander Hyhlik-Dürr27, Christoph M Seiler28, Thilo Hackert2, Christoph Reissfelder29, René Hennig30, Colette Doerr-Harim31, Christina Klose3, Alexis Ulrich2, Markus W Büchler32. 1. Study Centre of the German Surgical Society, University of Heidelberg, Heidelberg, Germany; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. 2. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. 3. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany. 4. Department of General and Visceral Surgery, University Medical Center, Georg-August-Universität, Göttingen, Germany. 5. Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, Ludwig-Maximilians-Universität Munich, Großhadern Campus, Munich, Germany. 6. Visceral and Vascular Surgery, Vivantes Klinikum Neukölln, Berlin, Germany. 7. Department of General, Visceral, Vascular and Thoracic Surgery, Campus Charité Mitte, Berlin, Germany. 8. Department of General, Visceral and Trauma Surgery, St Josefs Hospital Dortmund-Hörde, Dortmund, Germany. 9. Clinic for General and Visceral Surgery, Unfallkrankenhaus Berlin, Berlin, Germany. 10. Clinic for General and Visceral Surgery, St Joseph Hospital Berlin Tempelhof, Berlin, Germany. 11. Department of General, Abdominal and Minimal Invasive Surgery, Krankenhaus Salem, Department of Surgery, Heidelberg, Germany. 12. Department of General, Visceral and Minimal Invasive Surgery, Park-Klinik Weißensee, Berlin, Germany. 13. Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany. 14. Clinic for General, Visceral and Transplantation Surgery, Universitätsmedizin Mainz, Mainz, Germany. 15. Department for General, Visceral, Thoracic and Vascular Surgery, Universitätsmedizin Greifswald, Greifswald, Germany. 16. Clinic for Surgery, Kliniken des Landkreises Neumarkt i. d. Oberpfalz, Neumarkt, Germany. 17. Clinic for General, Visceral and Thoracic Surgery, Marienhospital Stuttgart, Stuttgart, Germany. 18. Clinic for Surgery, University Clinic Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. 19. Clinic for General, Visceral and Thorax Surgery, Klinikum am Steinenberg Reutlingen, Reutlingen, Germany. 20. Department for General, Visceral and Trauma Surgery, Krankenhaus der Augustinerinnen, Cologne, Germany. 21. Clinic for General, Visceral, Thoracic, Transplantation and Pediatric Surgery Universitätsklinikum Schleswig-Holstein, Kiel, Germany. 22. Department of Surgery, Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany. 23. Department of General and Visceral Surgery, Asklepios Klinik Harburg, Hamburg, Germany. 24. Department of General and Visceral Surgery, Albert-Ludwig University, Freiburg, Germany. 25. Department of General, Visceral and Transplantation Surgery, Charité Campus Virchow Klinikum, Berlin, Germany. 26. Department of General and Visceral Surgery, GRN Klinik Sinsheim, Sinsheim, Germany. 27. Department of Vascular and Endovascular Surgery, University of Heidelberg, Heidelberg, Germany. 28. Department of General, Visceral and Vascular Surgery, Josephs-Hospital Warendorf, Germany. 29. Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany. 30. Department of General and Visceral Surgery, Katharinenhospital, Stuttgart, Germany. 31. Study Centre of the German Surgical Society, University of Heidelberg, Heidelberg, Germany. 32. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. Electronic address: markus.buechler@med.uni-heidelberg.de.
Abstract
BACKGROUND: Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. METHODS: This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwentelective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to eithertriclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. FINDINGS:Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66-1·25; p=0·64). Serious adverse events also did not differ between the groups-146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). INTERPRETATION:Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. FUNDING: Johnson & Johnson Medical Limited.
RCT Entities:
BACKGROUND: Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. METHODS: This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. FINDINGS: Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66-1·25; p=0·64). Serious adverse events also did not differ between the groups-146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). INTERPRETATION:Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. FUNDING: Johnson & Johnson Medical Limited.
Authors: Tara C Mueller; Martin Loos; Bernhard Haller; André L Mihaljevic; Ulrich Nitsche; Dirk Wilhelm; Helmut Friess; Jörg Kleeff; Franz G Bader Journal: Langenbecks Arch Surg Date: 2015-02-14 Impact factor: 3.445