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

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

doi:10.1016/S0140-6736(14)60238-5

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

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

^*Corresponding author for this work

Clinic of Surgery

163 Citations (Scopus)

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 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.

Original language	English
Journal	The Lancet
Volume	384
Issue number	9938
Pages (from-to)	142-152
Number of pages	11
ISSN	0140-6736
DOIs	https://doi.org/10.1016/S0140-6736(14)60238-5
Publication status	Published - 12.07.2014

Funding

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. 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.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research Areas and Centers

Research Area: Luebeck Integrated Oncology Network (LION)

Access to Document

10.1016/S0140-6736(14)60238-5

Cite this

Diener, M. K., Knebel, P., Kieser, M., Schüler, P., Schiergens, T. S., Atanassov, V., Neudecker, J., Stein, E., Thielemann, H., Kunz, R., Von Frankenberg, M., Schernikau, U., Bunse, J., Jansen-Winkeln, B., Partecke, L. I., Prechtl, G., Pochhammer, J., Bouchard, R., Hodina, R., ... Büchler, M. W. (2014). 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. The Lancet, 384(9938), 142-152. https://doi.org/10.1016/S0140-6736(14)60238-5

@article{195c0208ad7c4958a3b7d15fd859376e,

title = "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",

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 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.",

author = "Diener, \{Markus K.\} and Phillip Knebel and Meinhard Kieser and Philipp Sch{\"u}ler and Schiergens, \{Tobias S.\} and Vladimir Atanassov and Jens Neudecker and Erwin Stein and Henryk Thielemann and Reiner Kunz and \{Von Frankenberg\}, Moritz and Utz Schernikau and J{\"o}rg Bunse and Boris Jansen-Winkeln and Partecke, \{Lars I.\} and Gerald Prechtl and Julius Pochhammer and Ralf Bouchard and Ren{\'e} Hodina and Beckurts, \{K. Tobias E.\} and Lothar Lei{\ss}ner and Lemmens, \{Hans Peter\} and Friedrich Kallinowski and Oliver Thomusch and Daniel Seehofer and Thomas Simon and Alexander Hyhlik-D{\"u}rr and Seiler, \{Christoph M.\} and Thilo Hackert and Christoph Reissfelder and Ren{\'e} Hennig and Colette Doerr-Harim and Christina Klose and Alexis Ulrich and B{\"u}chler, \{Markus W.\}",

note = "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.",

year = "2014",

month = jul,

day = "12",

doi = "10.1016/S0140-6736(14)60238-5",

language = "English",

volume = "384",

pages = "142--152",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "9938",

}

Diener, MK, Knebel, P, Kieser, M, Schüler, P, Schiergens, TS, Atanassov, V, Neudecker, J, Stein, E, Thielemann, H, Kunz, R, Von Frankenberg, M, Schernikau, U, Bunse, J, Jansen-Winkeln, B, Partecke, LI, Prechtl, G, Pochhammer, J, Bouchard, R, Hodina, R, Beckurts, KTE, Leißner, L, Lemmens, HP, Kallinowski, F, Thomusch, O, Seehofer, D, Simon, T, Hyhlik-Dürr, A, Seiler, CM, Hackert, T, Reissfelder, C, Hennig, R, Doerr-Harim, C, Klose, C, Ulrich, A & Büchler, MW 2014, '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', The Lancet, vol. 384, no. 9938, pp. 142-152. https://doi.org/10.1016/S0140-6736(14)60238-5

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. / Diener, Markus K.; Knebel, Phillip; Kieser, Meinhard et al.
In: The Lancet, Vol. 384, No. 9938, 12.07.2014, p. 142-152.

Research output: Journal Articles › Journal articles › Research › peer-review

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 - https://www.scopus.com/pages/publications/84904202633

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 -

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

Abstract

Funding

UN SDGs

Research Areas and Centers

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