Innovative Antimicrobial Wound Gel – Balancing Saftey with Biofilm Destruction

Lead Presenter

Supporting Presenters

Suprena Poleon1
Steven Davis2
Jie Li, MD, PhD2
Joe Gil2
Ann Beal Salamone1
Joseph C. Salamone, PhD1
1. Rochal Industries, San Antonio, TX
2. University of Miami, Miami, FL

Presented At

Abstract

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 three (n=8/group) and six (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 three) 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 six, 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