Clinical Efficacy Assessment of a Novel Biofilm Disrupting Wound Wash* and Antimicrobial Gel# Compared to Standard of Care

Background: Biofilm and bacterial bioburden exists in sections of a wound bed rather than evenly distributed over the wound surface. Debridement effectiveness and healing can be enhanced if these sections of biofilm and bacteria are greatly reduced or eliminated pre-debridement preventing bacterial inoculation by the procedure. The National Institutes of Health estimates that biofilm-based infections disease represent up to 80% of all forms of infectious disease. Scientific investigation has confirmed the presence of biofilm in 80-90% of chronic wounds compared to 6% or less in acute wounds, indicating that the presence of biofilm may explain the difference in treatment outcomes. Resistance is not only due to the physical barrier created by a rapidly established biofilm matrix but the expression of up to 800 new proteins secreted within hours of bacterial attachment/clustering. Recognizing the physical barrier and biofilm-inducing bacteria to become resistant requires an innovative approach in treatment that can eradicate biofilm regardless of bacterial diversity or the number of newly secreted proteins.

Methods: This is a 12 week, single-site, prospective, randomized clinical study. All patients in the study are randomized to treatment into one of three arms: one with the biofilm disrupting wound wash and sustained release antimicrobial gel along with Standard of Care debridement;  Standard of Care (SOC)  debridement with Hydrofiber based secondary dressing; or Standard of Care debridement with a silver-based Hydrofiber dressing.

Predicted Results: We anticipated that wounds treated pre-debridement with a biofilm eradication wound wash combined with sustained release biofilm eradication gel will exhibit improved rates of healing over Standard of Care. We also anticipated that wounds treated with Hydrofiber secondary dressings with or without a silver-based component, in addition to  Standard of Care debridement are less efficacious than the combination of a pre-debridement biofilm eradicating wound wash and sustained release antimicrobial gel.

*Poster is not available at this time.