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A double-blind trial comparing an antimicrobial combination to standard care in hard-to-heal wounds

Objective: Excessive numbers of bacteria in hard-to-heal wounds impede wound healing. Numerous topical antiseptics have demonstrated effectiveness in benchtop studies; however, few clinical studies have demonstrated efficacy in the target population: patients with hard-to-heal wounds. This study addressed the clinical efficacy of a novel antibiofilm cleanser and gel in reducing bacterial load and improving wound outcomes. Method: Hard-to-heal wounds were photographed, measured and evaluated for bacterial load using fluorescence imaging weekly for four weeks. The target ulcers were randomised to be cleaned and treated with either a synergistic antibiofilm cleanser and antibiofilm gel with standard of care (AMC-AMG + SoC) or normal saline wash and an amorphous gel with standard of care (NSS-HG + SoC). Results: A Chi-squared test of independence determined that the relationship between the treatment and the patient reaching 40% percentage area reduction (PAR) in four weeks was not significant (χ2(1, n=54)=0.73; p=0.39 at a significance level of 0.05); however, there was a strong trend favouring the antibiofilm cleanser and gel. A significant reduction (p<0.05) in bacterial load was observed in the antibiofilm group. Conclusion: This randomised controlled double-blind proof-ofconcept study suggests that the performance of antibiofilm agents in vivo is comparable to that in vitro studies. Declaration of interest: This research was funded by an unrestricted grant from Sanara MedTech. The clinical trial was conducted independently. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. The authors have no conflict of interest to declare.

antibiofilm treatment  ●  antiseptics  ●  biofilm  ●  chronic wound  ●  clinical trial  ●  hard-to-heal wound  ●  wound  ●  wound care  ●  wound dressing  ●  wound cleanser  ●  wound healing

Hard-to-heal wounds, a silent epidemic, affect millions worldwide.1 These patients suffer emotional and physical distress, reduced mobility, social isolation and financial hardship. In addition, wound healing constitutes a major economic burden, with annual costs estimated at $98 billion USD in the US alone.2 The practice of advanced wound care, an emerging specialty, has developed to address the needs of the rapidly rising population of patients with hardto-heal wounds. Typical of a new specialty, there is a lack of clinical evidence for much of everyday practice. In particular, treating clinically significant levels of bacteria in hard-to-heal wounds.3

The routine use of topical antiseptic cleansers and therapies is commonplace in wound centres across the US and globally. The term ‘wound hygiene’ is often used to promote the use of antiseptics;4 however, the evidence for this practice is based largely on in vitro studies. One of the reasons for the lack of clinical evidence was the difficulty in conducting clinical trials

Maha Khan,1 Medical Student; Emily King,2 MS, Statistician; Kristy Breisinger,2 Project Lead; Laura Serena,2 MEd, LPN, Chief Research Officer; Thomas E Serena,2 MD, Medical Director* *Corresponding author email: 1  Texas Christian University, Anne Marie Burnett School of Medicine, Fort Worth, TX, US.  2  SerenaGroup Research, US.

on antiseptics. The advent of point-of-care fluorescence imaging (MolecuLight, Canada) has simplified antiseptic clinical trials. In a 350-patient clinical trial, fluorescence imaging was shown to accurately detect clinically significant bacterial load in a wide variety of hard-to-heal wounds.5 The use of this validated technology permitted the comparison of antibiofilm therapies to saline and an amorphous gel.

It is estimated that >70% of hard-to-heal wounds contain biofilm-based bacteria.6 Most topical antiseptics cannot disrupt biofilm due to the extracellular polymeric substance (EPS) that protects the bacteria within the biofilm. To kill the biofilm bacteria, the antiseptic therapy must first disrupt the EPS.7 A novel antibiofilm agent, PHMB-1 (Sanara MedTech, US) is formulated to disrupt the biofilm and kill bacteria. It is composed of 0.1% polyhexamethylene biguanide (PHMB), purified water, poloxamer 407, sodium chloride, ethylhexylglycerin, hypromellose, octane‑1,2‑diol, and edetate disodium and edetate trisodium chelating agents. The reasoning behind the formulation is to use the poloxamer 407 surfactant and the EDTA agents to disrupt the biofilm, allowing the PHMB to kill the bacteria. The additional ingredients are designed to reduce the reformation of biofilms. Laboratory studies demonstrated that the PHMB-1 wound cleanser and gel formulations were effective in treating immature and mature biofilms produced by meticillin-resistant

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