This thesis provides an overview of the design, conduct and analysis of a multicentre phase III trial exploring the clinical effectiveness of a novel in-theatre intervention to try to reduce rates of post-operative surgical site infection (SSI). The pitfalls inherent in the conduct of research into SSI are discussed, along with measures to try and overcome these. The wound-edge protection device (WEPD) intervention is defined and the published evidence assessing its clinical effectiveness systematically appraised. Clinical surgical research and its difficulties are described, and the paradigm-shift bought about by the new trainee-led research collaborative model introduced. The design considerations involved creating a pragmatic and simple trial within the complex intervention that is surgery are explored in the context of the creation of the ROSSINI trial. This trial successfully recruited ahead of time and target and robustly proved that WEPDs are not clinically effective in reducing SSI. It also demonstrated the power and ability of this new collaborative model, as witnessed by both the citations of the results paper and the exponential growth in similar collaborative ventures. Finally, lessons learned about SSI research and clinical surgical research are summarised, and plans for future research presented.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:715715 |
| Date | January 2017 |
| Creators | Pinkney, Thomas David |
| Publisher | University of Birmingham |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://etheses.bham.ac.uk//id/eprint/7588/ |
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