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Prevention of microbial biofilms on  implantable materials in vitro with BIASURGE™ Advanced Surgical Solution  

Authors: Larry Estlack, Rebecca McMahon, PhD, Nina Bionda, PhD  

I. Introduction 

Biofilms are complex communities of bacteria which reside within an exopolysaccharide matrix adhered  to biotic or abiotic surfaces.1 In the clinic, biofilms are associated with nosocomial, chronic, and device related infections.2,3 Due to the intrinsic antibiotic tolerance and development of antibiotic resistance,  biofilms are notoriously difficult to treat.4 With the rapid advancements in the development of  implantable devices and the risks of device contamination, the issue of implant-associated infections is  garnering significant interest.3,5 These infections affect patients’ quality of life, contribute significantly to  patient morbidity and mortality, and pose a high burden to the healthcare system.  

This white paper presents the results of a series of in vitro studies aimed at evaluating both prevention of  microbial colonization of four different implantable materials, as well as eradication of bacteria already  attached to the surface of these materials. The experimental methodology, considerations, and findings are  discussed in detail below. 

The results demonstrate that BIASURGE Advanced Surgical Solution significantly reduces the bioburden  on a variety of materials in vitro, both in the prevention and in the eradication model.  

II. Methodology 

Four different implantable materials in shape of coupons ½’’ in diameter were used in this testing:  stainless steel (SS), cobalt-chromium alloy (CoCr), titanium alloy (Ti-6AL-4V), and ultra-high molecular  weight (UHMW) polyethylene. The coupons were acquired from a commercial source (BioSurface  Technologies Corporation, Bozeman, MT) and used without additional surface modifications. Coupons were glued to the bottom of 12-well plates using medical grade silicone adhesive. Two pathogenic bacteria were used as model organisms, Gram-positive methicillin-resistant Staphylococcus aureus (MRSA) ATCC BAA-1717 and Gram-negative Pseudomonas aeruginosa ATCC 9027. Schematic of the experimental set up is shown in  

Figure 1. Schematic representation of the experimental set up.

©2023 Sanara MedTech. All rights reserved. MKT.15.09 231118 

Prevention model: To evaluate effectiveness of BIASURGE Advanced Surgical Solution in preventing  attachment of bacteria (Figure 1A), the coupons were first exposed to BIASURGE for 10 minutes  followed by a wash twice with PBS and addition of 3×106 CFU of bacteria in full strength growth broth.  Following 10 minutes of contact time with the inoculum, the coupons were detached from the plate and  the bacteria present on the material was recovered through a series of sonication debridement steps. The  bacteria were enumerated using standard serial dilution and agar plating methodology.  

Eradication model: To evaluate effectiveness of BIASURGE Advanced Surgical Solution in disrupting  preformed biofilms (Figure 1B), the coupons were first inoculated with approximately 106 CFUs of  bacteria and incubated at 37°C for 24 h to allow formation of immature biofilms. The non-adhered  bacteria were removed through washing with PBS and the coupons were then subjected to a 10 minute  treatment with BIASURGE. Enumeration of bacteria remaining on the material surface was performed as  described above. 

III. Results 

The results of the prevention assay are summarized in Figure 2A and demonstrate that BIASURGE  Advanced Surgical Solution is effective at preventing microbial attachment to a variety of implantable  surfaces. Pre-treatment of all four materials evaluated in this study with BIASURGE Advanced Surgical  Solution resulted in at least 5-log reduction of the bioburden introduced onto the materials.  

Figure 2A. Prevention model- results

©2023 Sanara MedTech. All rights reserved. MKT.15.09 231118 

Figure 2B. Eradication model- results 

In the eradication model where disruption of preformed biofilms was evaluated (Figure 2B), treatment of  24 h old biofilms with BIASURGE Advanced Surgical Solution again resulted in approximately 5-log  reduction of the bioburden from all four materials evaluated.  

IV. Conclusions 

BIASURGE Advanced Surgical Solution is a no-rinse irrigation solution based on the synergistic  mechanism of action of a combination of EDTAs, PHMB, and vicinal diols.6 Considering that microbial  attachment is the critical first step in surface colonization and subsequent biofilm formation, we designed  a series of studies to evaluate the use of BIASURGE Advanced Surgical Solution in the presence of a  variety of implantable materials and simulated microbial contamination scenarios. The findings of the in  vitro studies discussed here demonstrate that BIASURGE Advanced Surgical Solution is:  

• Effective at significantly preventing attachment of bacteria to a variety of implantable materials. • Effective at significantly reducing existing bioburden from the surface of a variety of implantable  materials.  

The data shown here, coupled with the rapid microbicidal efficacy of planktonic microorganisms shown  in the kill-rate study7, demonstrate the potential for BIASURGE Advanced Surgical Solution to make a  clinical impact in reducing complications due to implant-associated infections. Targeted clinical studies  are being designed to confirm this hypothesis.

©2023 Sanara MedTech. All rights reserved. MKT.15.09 231118 

V. References 

1. Costerton JW, Lewandowski Z, Caldwell DE, Korber DR, Lappin-Scott HM. Microbial biofilms. Annu  Rev Microbiol. 1995; 49: 711-45. 

2. Khatoon Z, McTiernan CD, Suuronen EJ, Mah TF, Alarcon EI. Bacterial biofilm formation on  implantable devices and approaches to its treatment and prevention. Heliyon. 2018; 4(12): e01067. 

3. Arciola CR, Campoccia D, Montanaro L. Implant infections: adhesion, biofilm formation and immune  evasion. Nat Rev Microbiol. 2018; 16(7): 397-409. 

4. Sharma, D., Misba, L. & Khan, A.U. Antibiotics versus biofilm: an emerging battleground in microbial  communities. Antimicrob Resist Infect Control 8, 76 (2019). 

5. Stoodley P., Hall-Stoodley L., Costerton B., DeMeo P., Shirtliff M., Gawalt E., Kathju S. 2013.  Biofilms, Biomaterials, and Device-Related Infections, Handbook of Polymer Applications in Medicine  and Medical Devices; 77–101. 

6. Salamone AB, Salamone JC, McMahon RE, Poleon S, Bionda N, D’Arpa P. Synergistic Effect and  Antibiofilm Activity of a Skin and Wound Cleanser. Wounds. 2020; 32(8): 208-216.  

7. Estlack L, McMahon, RE, Bionda, N. Evaluation of Microbicidal Efficacy of BIASURGE™ Advanced  Surgical Solution. 2020; white paper, data on file

Nina assumed the role of Director of Research at Rochal Technologies, the Research and Development arm of Sanara MedTech, in September 2022. In this position, she bears the responsibility of orchestrating the conception and execution of critical internal and external studies vital for advancing surgical and wound care products. Dr. Bionda holds a BS degree in Biochemical Engineering from University of Zagreb and a PhD in Chemistry from Florida Atlantic University. Following her postdoctoral training at the University of Rochester, she spent seven years at a pre-clinical Contract Research Organization (CRO) specializing in the comprehensive evaluation of diverse medical devices. During this time, she led projects ranging from essential R&D support to generating pivotal data for FDA submissions and post-market studies.

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