Seidel, Dörthe http://orcid.org/0000-0002-2287-5217
Diedrich, Stephan
Herrle, Florian
Thielemann, Henryk
Marusch, Frank
Schirren, Rebekka
Talaulicar, Recca
Gehrig, Tobias
Lehwald-Tywuschik, Nadja
Glanemann, Matthias
Bunse, Jörg
Hüttemann, Martin
Braumann, Chris
Heizmann, Oleg
Miserez, Marc
Krönert, Thomas
Gretschel, Stephan
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Ambulatory negative pressure wound therapy of subcutaneous abdominal wounds after surgery: results of the SAWHI randomized clinical trial
https://doi.org/10.1186/s12893-022-01863-x
Funding for this research was provided by:
Private Universität Witten/Herdecke gGmbH
Article History
Received: 4 October 2022
Accepted: 22 November 2022
First Online: 12 December 2022
Declarations
:
: The study protocol and the informed consent documents were approved by the lead ethical committee (EC) of the Witten/Herdecke University. Ethical approval has been fully granted without any conditions. The study was performed in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice 1996 and in the spirit of the Declaration of Helsinki concerning medical research in humans (latest edition). Due to performing the trial according to § 23b MPG (German Medical Device Act), participating study sites in Germany only received a consultation for the main clinical investigator according to professional law by the respective EC. All investigators have been fully approved by the respective ECs. An evaluation of the study’s content by ECs of participating study sites in Germany was not applicable. Written informed consent was obtained from every patient after being informed about all aspects of the trial, and before randomization and any trial-related procedure.
: Not applicable.
: Dörthe Seidel reports grant from Kinetic Concepts Incorporated (KCI), an Acelity company, during the conduct of the study. She was an employee of the UW/H. Outside the submitted work but for a study in the same research area, she reports honoraria for lectures and grants from Smith & Nephew, KCI, and from German statutory health insurance funds (AOK-Bundesverband, Verband der Ersatzkrankenkassen (vdek), Knappschaft) for a study on NPWT in diabetic foot ulcers. Furthermore, she reports honoraria for lectures from Smith & Nephew and Hartmann. All members of the SAWHI study group, listed as co-authors, received a case fee for each patient included in the SAWHI study in order to compensate for the additional organizational and especially the documentation effort during trial conduct. Furthermore, all investigators received compensation for travelling to the investigator meetings.