TY - JOUR
T1 - Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: The randomised controlled PROUD trial
AU - Diener, Markus K.
AU - Knebel, Phillip
AU - Kieser, Meinhard
AU - Schüler, Philipp
AU - Schiergens, Tobias S.
AU - Atanassov, Vladimir
AU - Neudecker, Jens
AU - Stein, Erwin
AU - Thielemann, Henryk
AU - Kunz, Reiner
AU - Von Frankenberg, Moritz
AU - Schernikau, Utz
AU - Bunse, Jörg
AU - Jansen-Winkeln, Boris
AU - Partecke, Lars I.
AU - Prechtl, Gerald
AU - Pochhammer, Julius
AU - Bouchard, Ralf
AU - Hodina, René
AU - Beckurts, K. Tobias E.
AU - Leißner, Lothar
AU - Lemmens, Hans Peter
AU - Kallinowski, Friedrich
AU - Thomusch, Oliver
AU - Seehofer, Daniel
AU - Simon, Thomas
AU - Hyhlik-Dürr, Alexander
AU - Seiler, Christoph M.
AU - Hackert, Thilo
AU - Reissfelder, Christoph
AU - Hennig, René
AU - Doerr-Harim, Colette
AU - Klose, Christina
AU - Ulrich, Alexis
AU - Büchler, Markus W.
N1 - Funding Information:
Funding of project and data management, biometry and statistical analysis, case payment, material (sutures, case report forms, digital cameras, trial master file, and investigator site file), trial committees, investigator meetings, and internet tools was provided by Johnson & Johnson Medical Limited (Scotland, UK). Investigators received no financial incentives from the funding source. PROUD was an investigator-initiated trial and the funder had no role in study design, data collection, data analysis, data interpretation, or the writing of the report. MKD, MK, and MWB had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Funding Information:
This trial was funded by a grant from Johnson & Johnson Medical Limited. We thank the staff of all participating centres of the PROUD trial Group and the German Surgical Research Network (CHIR- Net )—a network for clinical research in surgery—for their outstanding engagement and support of the trial.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2014/7/12
Y1 - 2014/7/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84904202633&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(14)60238-5
DO - 10.1016/S0140-6736(14)60238-5
M3 - Journal articles
C2 - 24718270
AN - SCOPUS:84904202633
SN - 0140-6736
VL - 384
SP - 142
EP - 152
JO - The Lancet
JF - The Lancet
IS - 9938
ER -
