Antimicrobial Activity of an Adhesive Containing Chlorhexidine Gluconate (CHG) Neal Carty, Ph.D. Anne Wibaux, Pharm.D. Peter Johnson, M.D. Vancive Medical Technologies, An Avery Dennison business Abstract Methods This study aimed to evaluate the antimicrobial activity of an IV securement dressing, featuring a novel adhesive containing chlorhexidine gluconate (CHG), against healthy volunteers’ native skin flora. Pre-Test: Subjects refrained from using antibacterial products for one week. No other skin preparation was used. Application: Dressings were randomly assigned to four quadrants on each subject’s back. A baseline sample was taken from the center of each quadrant before application. Quantitative cultures were taken from skin underneath dressings that had been worn for up to 7 days. The CHG adhesive was compared to an ordinary film dressing as a control. The CHG adhesive was associated with a mean reduction of 0.9 to 1.3 log10 cfu/cm2 below baseline for the entire 7 days, whereas bacteria underneath the control grew from a 0.7 log reduction to a 1.3 log increase during the same period of time. The CHG Adhesive used in an IV securement dressing Data Collection: Subjects returned after 1, 4, and 7 days’ wear. One dressing per quadrant was removed and a sample taken from the skin underneath using the cylinder sampling technique. Skin irritation was graded using the BergerBowman scale. Sub-quadrants counted incrementally over time (1, 4, 7 days) There were no incidents of skin irritation, even when used in combination with a CHG-containing skin prep. Objectives 1.  An in vivo evaluation of the the antimicrobial activity of the CHGcontaining adhesive against the skin’s resident microflora. Control CHG Adhesive 2.  An in vivo evaluation of the dressing’s propensity to cause skin irritation Photograph of test materials as applied to one subject’s back. MTR-MKT-000088 BL BL BL BL One treatment condition per quadrant Baseline counts from center of each quadrant Diagram illustrating the arrangement of test materials on the subjects’ backs. Antimicrobial Activity of an Adhesive Containing Chlorhexidine Gluconate (CHG) Neal Carty, Ph.D. Anne Wibaux, Pharm.D. Peter Johnson, M.D. Vancive Medical Technologies, An Avery Dennison business Results Excluded quadrants with baseline < 2.5 log cfu/cm2. The average bacterial recoveries from baseline sites and from underneath the dressings were as follows: CHG Adhesive: average log reduction varied between 0.9 and 1.3 log10 cfu/cm2 SEM† Time N Day 0 Day 1 44 22 3.24 2.41 0.09 0.26 22 20 22 22 21 2.51 1.92 2.52 4.06 4.49 0.35 0.33 0.28 0.34 0.34 Day 4 Day 7 Control Day 1 Day 4 † SEM = standard error of the mean Day 7 (log10 cfu/ (log10 cfu/cm2) cm2) Control: average log reduction dropped from 0.7 log10 cfu/cm2 on Day 1 down to -1.3 log10 cfu/cm2 (a 1.3 log increase) by Day 7 2" 1" 0" -1" -2" Log Baseline CHG Adhesive Average Computed log reductions by subtracting each under-dressing recovery from its corresponding quadrant’s baseline count. CH 0" 1" 2" 3" 4" 5" 6" 7" G Day! **Blocked, two-factor ANOVA established both dressing type and day as significant factors (p < 0.005 for each). Skin Irritation Results: At no point during the study did any site score greater than “minimal erythema, barely perceptible” on the Berger-Bowman scale. Conclusions  The CHG-containing adhesive was associated with a sustained antimicrobial effect that was not present in the control.   Neither dressing potentiated skin irritation among the study’s healthy human volunteers. For questions or further information please contact one of our Global Segment Managers: Barbara Van Rymenam: [email protected] Crystal Humphreys: [email protected]