Abstract
Purpose
Infection rates following ankle fractures are as high as 19% in selected material and is the most common complication following this type of surgery, with potential catastrophic consequences. The purpose of this study was to test a regime of intermittent pneumatic compression, a compression bandage and a compression stocking and its effect on the rate of wound complications. The hypothesis was that compression could lower the infection rate from 20 to 5%.
Methods
We performed a randomized, controlled, non-blinded trial, including 153 adult patients with unstable ankle fractures. Patients were randomized to either compression (N = 82) or elevation (N = 71). Patients with open fracture, DVT, pulmonary embolism, dementia, no pedal pulse, or no Danish address were excluded. Primary endpoint was infection. Secondary endpoints were necrosis and wound dehiscence.
Results
After 2 weeks, 1.4% (0.0;7.6) in the compression group had infection compared to 4.6% (1.0;12.9) in the control group, p = 0.35. The rate of necrosis after 2 weeks was 7.0% (95% CI 2.3;15.7) in the compression group compared with 26.2% (95% CI 16.0;38.5) in the elevation group, p = 0.004. No difference was shown regarding wound dehiscence.
Conclusion
Based on this study, we cannot conclude if compression therapy prevents infection or not. This is mainly due to under-powering of the study. The effect on necrosis was in favor of compression, but the trial was not powered to show a difference regarding this endpoints and the result is thus hypothesis generating. Further research is needed before a thorough recommendation on the use of compression treatment that can be made.
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Acknowledgements
Thanks to Freja Zahle, MD for collecting data. Thanks to doctors and nurses at the Emergency Department for assessment and inclusion of patients. Thanks to Jan Sørensen, MD and Nina Bækmark RN for laying the groundwork for the project and thanks to Head of Department Leif Berner Hansen for economic support.
Funding
The study was funded by the Research Unit, the Department of Orthopedic Surgery, Nordsjællands Hospital, and The Olga Bryde Foundation.
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Contributions
All authors contributed to the idea and interpretation of the results and writing of this manuscript. The first author RW was responsible for the data collection. RW wrote and prepared the first draft of the manuscript, with input from all the coauthors CR, HG, LB, and TWC, all of whom approved the decision to submit the manuscript for publication. TWC is responsible for the statistical analyses together with RW.
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Informed consent
The study was approved by The Danish Data Protection Agency first time in December 2012 (2012-41-1331) and second time in December 2014 (NOH-2014-035), due to a faulty administration procedure. All participating patients signed an informed consent form, before being included in the study.
Conflict of interest
All authors declare that they have no conflict of interests. Disclosures of conflicts of interest signed by all authors are appended to the manuscript.
Ethical standards
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Winge, R., Ryge, C., Bayer, L. et al. Wound complications after ankle surgery. Does compression treatment work? A randomized, controlled trial. Eur J Trauma Emerg Surg 44, 947–956 (2018). https://doi.org/10.1007/s00068-017-0892-5
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DOI: https://doi.org/10.1007/s00068-017-0892-5