Pre-Operative Skin Preparation
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 and pre-injection products, includes a methodology for testing vascular pre-catheterization 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 pre-catheterization 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 pre-operative 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 pre-operative preparations and 30 seconds for pre-injections preparations), 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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CAS103Clinical Antiseptic: ASTM, FDA FM Pre-Op Prep - ASTM E1173, FDA Monograph