Vladimir Atanassov, Hans-Peter Lemmens, Oliver Thomusch, Christoph M. Seiler, Markus W. Büchler, Markus K. Diener, Ralf Bouchard, Thilo Hackert, Jens Neudecker, Alexis Ulrich, Reiner Kunz, Lars Ivo Partecke, Meinhard Kieser, Daniel Seehofer, Boris Jansen-Winkeln, Colette Doerr-Harim, Alexander Hyhlik-Dürr, Moritz von Frankenberg, Rene Hennig, Tobias S. Schiergens, Thomas Simon, K Tobias E Beckurts, Lothar Leißner, Jörg Bunse, Henryk Thielemann, Utz Schernikau, Christoph Reissfelder, Erwin Stein, Gerald Prechtl, Julius Pochhammer, Christina Klose, Phillip Knebel, Philipp Schüler, F. Kallinowski, and René Hodina
Summary 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.