Microflora analysis
ProVate
Evaluation was performed using Gram stain counts of colony forming units/high power field (CFU/HPF) for The changes in Gram stain semi-quantitative counts for each of the four microorganisms before ProVate or control device insertion (visits 2/5) as compared to the end of the use period (visits 5/7) were recorded as either beneficial, non-beneficial, or no change, using a 0–4 scale. No change was defined as a score of + 1 to–1, and a meaningful change as a change in score of + 2– + 4 or − 2– − 4 (beneficial or non-beneficial for each microorganism).