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Disclosures and Registration: Lost in Translation?

Freshwater, M. Felix M.D.

Plastic and Reconstructive Surgery: February 2012 - Volume 129 - Issue 2 - p 367e
doi: 10.1097/PRS.0b013e31823aef69

University of Miami School of Medicine, 9100 South Dadeland Boulevard, Suite 502, Miami, Fla. 33156-7815

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I was intrigued by the article published ahead of print entitled “The Ideal Split-Thickness Skin Graft Donor-Site Dressing: A Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel.”

The Journal has abided by the Declaration of Helsinki since 2007 by only accepting for peer review prospective clinical trials that have been registered.2 Article 19 of the Declaration of Helsinki clearly states: “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject [italics added].”3 This article does not state in which publicly accessible database the trial was registered. When I searched the World Health Organization database of clinical trial registries that includes not only but also the German Clinical Trials Register, the only trial that I was able to find matching this article was clinical NCT01055925 that was not registered until January 25, 2010.4 This article states on page 24 that patient enrollment for this study commenced “in full accordance with the Helsinki declaration” in June of 2008. What happened? Is there some other publicly accessible registry not listed with the World Health Organization in which this trial was registered? Is the World Health Organization database incomplete? Did the quality control process of the Journal fail and an article that violated the Declaration of Helsinki and the Journal's own ethical standards somehow get peer-reviewed and accepted for publication? Is there some other explanation for why the only registry number that I could find for this trial was for a trial that had been registered more than 1 year after this trial began and 6 months after it ended?

M. Felix Freshwater, M.D.

University of Miami School of Medicine, 9100 South Dadeland Boulevard, Suite 502, Miami, Fla. 33156-7815

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1. Dornseifer U, Lonic D, Gerstung TI, et al.. The ideal split-thickness skin graft donor-site dressing: A clinical comparative trial of a modified polyurethane dressing and Aquacel. Plast Reconstr Surg. 2011;128:918–924.
    2. Rohrich RJ, Longaker MT. Registering clinical trials in Plastic and Reconstructive Surgery. Plast Reconstr Surg. 2007;119:1097–1099.
    3. World Medical Association. WMA Declaration of Helsinki: Ethical principles for medical research involving human subjects. Available at: Accessed July 24, 2011.
    4. Clinical comparative trial of a modified polyurethane dressing and Aquacel. Available at: Accessed July 24, 2011.
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