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The FDA has a process in place for formal evaluation of the results of these studies. Of note, also, is that ASTM's Standard Method E1173, which provides a nearly identical method for testing Pre-Operative/Preinjection products, includes methodology for testing vascular precatheterization and catheter maintenance products. Surrogate clinical testing of vascular precatheretization and catheter maintenance preparations can be valuable, and perhaps even necessary, for proof-of-concept prior to proceeding to the multi-center clinical trails.
Per specifications in the TFM and the ASTM E1173 methods for testing, the number of subjects needed per limb of the study should be calculated specific to the performance parameters of our clinical laboratory. The TFM requires that testing of preop preparations be performed on both dry skin and moist skin sites. For both pre-operative skin preparations and catheter maintenance preparations, it is required that the dry skin sites have base populations of normal microbial flora per cm2 high enough to demonstrate reductions in population of >2 log10 and that moist skin sites have populations high enough to demonstrate reductions of >3 log10, in both cases within 10 minutes of product application. Furthermore, preop and catheter maintenance perps must maintain microbial populations at less than the baseline populations for at least six and twelve hours post-application.
Following the sampling for baseline, test sites are treated with a product, and after times of exposure specified in the protocol (generally 30 seconds to 10 minutes for preop preps and 30 seconds for preinjections preps), cylinder sampling is performed, and the portion of a treated site intended for sampling at some future time (to verify maintenance of populations below baseline) are bandaged with gauze and a semi-occlusive adhesive tape. At the designated post-application times, these sites are uncovered and cylinder-sampled. As a general rules, all sites of a product application are visually assessed for signs of skin irritation at each sampling time, and if present, it is documented.
Our start-to-finish solution for clinical trials begins with understanding our client’s end goals for the study and aiding them in the study design. Throughout the project we remain in on-going contact with our sponsors to ensure that the project is managed with the best interest of the client in mind.…
These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing signiﬁcantly the number of organisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, to maintain reductions…
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