The FDA has a process in place for formal evaluation of the results of these studies. Also of note is that ASTM's Standard Method E1173, which provides a nearly identical method for testing Pre-Operative/Preinjection products, includes a methodology for testing vascular precatheterization and catheter maintenance products. Surrogate endpoint microbial reduction studies, such as the ASTM E1173, can be valuable and perhaps even necessary for initial proof-of-concept evaluations prior to proceeding into multi-center clinical outcome trials. The use of these methods is an effective way of evaluating a test product dose-response for use in clinical outcome trials of vascular precatheterization and catheter maintenance products.
Per specifications in the FDA Monograph and the ASTM E1173 methods for testing, the number of subjects needed per test material in the pivotal study to meet the mandated endpoint should be calculated specifically with the efficacy data from a pilot study.
The FDA Monograph requires that testing of preop preparations be performed on both dry skin and moist skin sites. This is accomplished by using inguinal sites as “moist skin sites” and abdominal sites as the “dry skin” sites. Following the sampling for baseline, test sites are treated with a product, and after times of exposure specified in the protocol (generally 10 minutes for preop preps and 30 seconds for pre injections 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 time points, these sites are uncovered and cylinder-sampled. As a general rule, all sites of a product application are visually assessed for signs of skin irritation at each sampling time and if irritation present, it is documented.
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Learn MoreStandard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations These procedures should be used to test topical antimicrobial-contai...
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