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November 17, 2010

Treating Sternal Wound Infections After Cardiac Surgery With an Implantable Gentamicin-Collagen Sponge

JAMA. 2010;304(19):2123-2124. doi:10.1001/jama.2010.1612

To the Editor: EUSA Pharma (Europe) Limited holds the European National Marketing Authorizations in various noncardiac surgical indications for the gentamicin-collagen sponge used in the clinical trial by Dr Bennett-Guerrero et al.1 I was concerned to discover, from both the study protocol and the investigator training video,2 that investigators were instructed to dip the sponge in normal saline solution for 1 to 2 seconds prior to implantation. This is not in line with instructions given in the European national product information3 (which generally state that the product should be used dry) and may have resulted in a degradation of the product's gentamicin release characteristics, gentamicin sulfate being highly soluble in aqueous solutions. This may in part explain the results of the study which are, as the authors state, contrary to expectations based on a number of positive studies conducted in Europe.4,5

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