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.
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
Johnson & Johnson Medical Limited.
Study Centre of the German Surgical Society, University of Heidelberg, Heidelberg, Germany; Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Markus K
MK
Diener
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Phillip
P
Knebel
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Meinhard
M
Kieser
Department of General and Visceral Surgery, University Medical Center, Georg-August-Universität, Göttingen, Germany.
Philipp
P
Schüler
Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, Ludwig-Maximilians-Universität Munich, Großhadern Campus, Munich, Germany.
Tobias S
TS
Schiergens
Visceral and Vascular Surgery, Vivantes Klinikum Neukölln, Berlin, Germany.
Vladimir
V
Atanassov
Department of General, Visceral, Vascular and Thoracic Surgery, Campus Charité Mitte, Berlin, Germany.
Jens
J
Neudecker
Department of General, Visceral and Trauma Surgery, St Josefs Hospital Dortmund-Hörde, Dortmund, Germany.
Erwin
E
Stein
Clinic for General and Visceral Surgery, Unfallkrankenhaus Berlin, Berlin, Germany.
Henryk
H
Thielemann
Clinic for General and Visceral Surgery, St Joseph Hospital Berlin Tempelhof, Berlin, Germany.
Reiner
R
Kunz
Department of General, Abdominal and Minimal Invasive Surgery, Krankenhaus Salem, Department of Surgery, Heidelberg, Germany.
Moritz
M
von Frankenberg
Department of General, Visceral and Minimal Invasive Surgery, Park-Klinik Weißensee, Berlin, Germany.
Utz
U
Schernikau
Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany.
Jörg
J
Bunse
Clinic for General, Visceral and Transplantation Surgery, Universitätsmedizin Mainz, Mainz, Germany.
Boris
B
Jansen-Winkeln
Department for General, Visceral, Thoracic and Vascular Surgery, Universitätsmedizin Greifswald, Greifswald, Germany.
Lars I
LI
Partecke
Clinic for Surgery, Kliniken des Landkreises Neumarkt i. d. Oberpfalz, Neumarkt, Germany.
Gerald
G
Prechtl
Clinic for General, Visceral and Thoracic Surgery, Marienhospital Stuttgart, Stuttgart, Germany.
Julius
J
Pochhammer
Clinic for Surgery, University Clinic Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Ralf
R
Bouchard
Clinic for General, Visceral and Thorax Surgery, Klinikum am Steinenberg Reutlingen, Reutlingen, Germany.
René
R
Hodina
Department for General, Visceral and Trauma Surgery, Krankenhaus der Augustinerinnen, Cologne, Germany.
K Tobias E
KT
Beckurts
Clinic for General, Visceral, Thoracic, Transplantation and Pediatric Surgery Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
Lothar
L
Leißner
Department of Surgery, Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany.
Hans-Peter
HP
Lemmens
Department of General and Visceral Surgery, Asklepios Klinik Harburg, Hamburg, Germany.
Friedrich
F
Kallinowski
Department of General and Visceral Surgery, Albert-Ludwig University, Freiburg, Germany.
Oliver
O
Thomusch
Department of General, Visceral and Transplantation Surgery, Charité Campus Virchow Klinikum, Berlin, Germany.
Daniel
D
Seehofer
Department of General and Visceral Surgery, GRN Klinik Sinsheim, Sinsheim, Germany.
Thomas
T
Simon
Department of Vascular and Endovascular Surgery, University of Heidelberg, Heidelberg, Germany.
Alexander
A
Hyhlik-Dürr
Department of General, Visceral and Vascular Surgery, Josephs-Hospital Warendorf, Germany.
Christoph M
CM
Seiler
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Thilo
T
Hackert
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.
Christoph
C
Reissfelder
Department of General and Visceral Surgery, Katharinenhospital, Stuttgart, Germany.
René
R
Hennig
Study Centre of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
Colette
C
Doerr-Harim
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Christina
C
Klose
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Alexis
A
Ulrich
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany. Electronic address: markus.buechler@med.uni-heidelberg.de.
Markus W
MW
Büchler
D034861:Abdominal Wall; D058107:Abdominal Wound Closure Techniques / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013530:Surgical Wound Infection / Q000517:prevention & control*; D013537:Sutures; D016896:Treatment Outcome; D014260:Triclosan / Q000008:administration & dosage*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D014260:Triclosan