Innovative Antimicrobial Wound Gel - Balancing Safety With Biofilm Destruction
Rebecca McMahon, PhD, Suprena Poleon, Ann Beal Salamone, Joe C. Salamone.
Rochal Industries, San Antonio, TX, USA.
Background: Wound biofilms, which are ubiquitous in chronic wounds, can cause inflammation and delayed wound healing. A novel Antimicrobial Wound Gel* has been formulated with synergistic mechanisms intended to safely eliminate wound biofilms. This formulation disrupts biofilm extracellular polymeric substances (EPS) by removing metal cations, disassembling lipids, and aggregating the polymers that create the structure so that the antimicrobial can target and kill the microbes. This research validates the safety profile of this biofilm destructing gel. Method: Biocompatibility was demonstrated using Agar Diffusion Testing, Primary Skin Irritation Testing, Direct Buehler Sensitization, and Pyrogen Testing, which were performed according to ISO 10993. Additionally, a swine wound healing study was performed to determine the effects of AWG on the local tissue response and healing of deep partial thickness excisional wounds using histology at days 3 (n=8/group) and 6 (n=4/group). A semi-quantitative analysis of several inflammatory cell types and extent of tissue response was performed. AWG was compared to a commercial control+ and an untreated control. Results: All biocompatibility test results were passing. On the early assessment day (day 3) of the wound healing study, local tissue response to AWG was comparable to the untreated control, while the commercial product showed a delay in epithelialization. By day 6, both treatment groups showed wound healing comparable to the untreated control. Conclusions: The findings confirm that the presence of biofilm disruption and antimicrobial agents within AWG do not negatively impact the biocompatibility or the natural wound healing process. *Sanara MedTech, Inc. BIAKŌSTM Antimicrobial Wound Gel, +B.Braun Prontosan Wound Gel X
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