ObjectivesTo evaluate the antimicrobial activity of a new, transparent composite film dressing, whose adhesive contains chlorhexidine gluconate (CHG), against the native microflora present on human skin.MethodsCHG-containing adhesive film dressings and non-antimicrobial control film dressings were applied to the skin on the backs of healthy human volunteers without antiseptic preparation. Dressings were removed 1, 4 or 7 days after application. The bacterial populations underneath were measured by quantitative cultures (cylinder-scrub technique) and compared with one another as a function of time.ResultsThe mean baseline microflora recovery was 3.24 log10 cfu/cm2. The mean log reductions from baseline measured from underneath the CHG-containing dressings were 0.87, 0.78 and 1.30 log10 cfu/cm2 on days 1, 4 and 7, respectively, compared with log reductions of 0.67, −0.87 and −1.29 log10 cfu/cm2 from underneath the control film dressings. There was no significant difference between the log reductions of the two treatments on day 1, but on days 4 and 7 the log reduction associated with the CHG adhesive was significantly higher than that associated with the control adhesive.ConclusionsThe adhesive containing CHG was associated with a sustained antimicrobial effect that was not present in the control. Incorporating the antimicrobial into the adhesive layer confers upon it bactericidal properties in marked contrast to the non-antimicrobial adhesive, which contributed to bacterial proliferation when the wear time was ≥4 days.

The dressing was well-received by both clinicians and patients in all fifteen cases. The thin absorbent skin adhesive dressing was found to be a promising new technology that could offer significant advantages to improve the quality, cost, and convenience of wound care. Further work is underway to validate these findings in larger and more homogeneous patient groups.

Background: Surgical site infection is a major postoperative complication after surgical procedures. The effectiveness of postoperative antimicrobial dressings in reducing surgical site infections is unclear and limited information is available on the efficacy of chlorhexidine gluconate (CHG)-impregnated postoperative dressings. Methods: A pilot study was conducted to examine the efficacy of an innovative CHG-impregnated postoperative dressing in reducing the burden of methicillin-resistant Staphylococcus aureus (MRSA) in an in vivo porcine, incisional-wound model. Sutured incisional wounds were contaminated with MRSA and then covered with a CHG wound dressing, a placebo control, or a nonantimicrobial gauze. The surviving MRSA population was quantitatively cultured 3 days postprocedure. Results: MRSA was not recovered from any of the 8 wounds that were treated with the CHG dressing (limit of detection, approximately 1.7 log 10 colony-forming units [cfu]/g tissue). In contrast, the average microbial recovery from wounds treated with the placebo dressing was 4.2 log 10 cfu/g and the average microbial recovery from wounds treated with the gauze dressing was 3.2 log 10 cfu/g. Conclusions: An innovative CHG dressing provided significant antimicrobial activity against MRSA contaminating a surgical wound in a porcine, incisional-wound model. Future clinical studies are needed to assess the efficacy of the CHG dressing to reduce the bacterial burden in postoperative wounds of surgical patients.

BackgroundCovering insertion sites with chlorhexidine impregnated dressings has been proven to be clinically effective in reducing catheter related blood stream infections (CR-BSI). Two chlorhexidine gluconate (CHG)-impregnated dressings are commercially available, a polyurethane foam disk and a film dressing containing a chlorhexidine gluconate-impregnated gel pad. While both have demonstrated efficacy in clinical settings, the major drawback of high cost and impaired IV insertion site visibility limits their usage. A new, simple film dressing containing CHG within its adhesive layer is now available. The objective of this study was to test the in vitro antimicrobial efficacy of the new dressing in comparison to the CHG-impregnated gel dressing.MethodsQuantitative aliquots of suspensions (concentration of 1.0x106 to 5.0x106 cfu/sample) of clinically relevant challenge organisms (Staphylococcus species, gram-negative bacilli, Candida albicans) were incubated in contact with the new CHG-containing film dressing, a placebo version of the same (negative control) and the commercially available CHG-impregnated gel dressing (positive control). Serial dilutions of the surviving organisms were quantified using the pour plate after 1, 3, 5, and 7 days of incubation in order to calculate an antimicrobial log10 reduction for each organism/dressing combination at each point in time.ResultsThe new CHG-containing film dressing delivered greater than 5.0 log10 reduction throughout the 7 days on all aerobic gram-negative bacilli and Staphylococcus species tested. As of day 1 the CHG-containing film dressing provided greater than 5.0 log10 reduction on Candida albicans. There were no statistically significant differences in the log10 reduction between the two dressings tested.ConclusionThe new CHG-containing film dressing was found to be as effective as the chlorhexidine gluconate-impregnated gel dressing on clinically relevant microbes.

The Industry Committee of the Tissue Engineering Regenerative Medicine International Society, Americas Chapter (TERMIS-AM) administered a survey to its membership in 2013 to assess the awareness of science requirements in the U.S. Food and Drug Administration (FDA) regulatory process. One hundred forty-four members responded to the survey. Their occupational and geographical representation was representative of the TERMIS-AM membership as a whole. The survey elicited basic demographic information, the degree to which members were involved in tissue engineering technology development, and their plans for future involvement in such development. The survey then assessed the awareness of general FDA scientific practices as well as specific science requirements for regulatory submissions to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Projects (OCP). The FDA-specific questions in the survey were culled from guidance documents posted on the FDA web site ( www.fda.gov ). One of the answer options was an opt-out clause that enabled survey respondents to claim a lack of sufficient awareness of the topic to answer the question. This enabled the stratification of respondents on the basis of confidence in the topic. Results indicate that across all occupational groups (academic, business, and government) that are represented in the TERMIS-AM membership, the awareness of FDA science requirements varies markedly. Those who performed best were for-profit company employees, consultants, and government employees; while students, professors, and respondents from outside the USA performed least well. Confidence in question topics was associated with increased correctness in responses across all groups, though the association between confidence and the ability to answer correctly was poorest among students and professors. Though 80% of respondents claimed involvement in the development of a tissue engineering technology, their responses were no more correct than those who were not. Among those developing tissue engineering technologies, few are taking advantage of existing standards organizations to strengthen their regulatory submissions. The data suggest that early exposure to regulatory experts would be of value for those seeking to bring their technology to the market. For all groups studied but especially for students and professors, formal initial or continuing education in Regulatory Science should be considered to best support translational tissue engineering research and development. In addition, the involvement of standards development organizations during tissue engineering technology development is strongly recommended.