Evaluation of Microbicidal Efficacy of BIASURGE® Advanced Surgical Solution

1. Introduction

Surgical Site Infections (SSIs) represent the most prevalent type of Hospital-Acquired Infections (HAIs), affecting 160,000 to 300,000 individuals annually and are linked to a 2-to 11-fold increase in mortality risk, with 75% of SSI-related deaths directly attributed to the infection.^1-3 Approximately 3% of surgery patients develop SSIs, leading to extended hospital stays and raising hospitalization costs by over $20,000 per admission. Consequently, SSIs impact US healthcare with an estimated staggering cost of around $3.3 billion annually.^{2, 4} The need for effective microbicidal solutions in healthcare settings is paramount to prevent infections and ensure patient safety. 

BIASURGE™ Advanced Surgical Solution (Sanara MedTech) is a no-rinse irrigation solution based on the synergistic mechanism of action of a combination of EDTAs, PHMB, and vicinal diols.⁵ 

This white paper presents the results of a series of studies conducted to evaluate the microbicidal efficacy of BIASURGE Advanced Surgical Solution against a panel of eighteen microorganisms over a 24-hour period, as well as USP <51> preservative challenge over the course of 28 days. The research methodology, results, and implications are discussed in detail.

The results demonstrate rapid and broad-spectrum microbicidal effect within BIASURGE Advanced Surgical Solution against various Gram-positive bacteria, Gram-negative bacteria, and yeasts in both short and extended time frames. 

2. Methodology

Kill-rate testing: Kill-rate testing was performed against a panel of eighteen microorganisms, including Gram-positive bacteria, Gram-negative bacteria, and yeasts (Figure 1). Briefly, aliquots of the BIASURGE solution were placed in sterile containers followed by the addition of the microbial inoculum (approximately 10⁷ CFU/mL) and thorough mixing. The inoculated test samples of BIASURGE were then placed into an incubator set at 37°C for the specified testing periods: 30 s, 1 min, 5 min, and 24 h.  At designated time points, an aliquot of the BIASURGE solution was neutralized and surviving microorganisms enumerated through serial dilution and agar plating. 

USP <51> testing: This testing followed the procedures outlined in the standard and utilized five common pathogens (Table 1). Briefly, aliquots of the BIASURGE solution were inoculated with approximately 10⁵ CFU/mL of the test microorganism. At designated time points (14 and 28 days), an aliquot of BIASURGE solution was removed and enumerated as described above.

3. Results

The results of the kill-rate testing are summarized in Table 1 and demonstrated the remarkable efficacy of BIASURGE Advanced Surgical Solution against all tested microorganisms. Within 30 seconds of contact, BIASURGE Advanced Surgical Solution reduced the microbial load of all 18 tested microorganisms by more than 5 logs (>99.999%). 

By 5 minutes, no survivors were detected for any of the tested microorganisms. Even after 24 hours of contact, no survivors were found, indicating the long-lasting microbicidal activity of BIASURGE Advanced Surgical Solution [Table 1]

[Table 1: Microorganism Kill Rate for BIASURGE Advanced Surgical Solution]

The USP<51> testing shown in Table 2 demonstrates that BIASURGE Advanced Surgical Solution, if contaminated post opening, preserves microbicidal efficacy over the course of at least 28 days.

[Table 2. Results of the USP <51> testing showing extended microbicidal effect within BIASURGE Advanced Surgical Solution]

4. Conclusion

The study findings highlight rapid and sustained microbicidal effect within the solution of BIASURGE Advanced Surgical Solution. The ability to eliminate a wide spectrum of microorganisms, including antibiotic-resistant strains, positions BIASURGE Advanced Surgical Solution as a promising solution in infection prevention strategies. Its rapid action, coupled with its enduring microbicidal activity, makes it a valuable asset in the fight against healthcare-associated infections. 

References

1. CDC, National Healthcare Safety Network: Surgical Site Infection Event (SSI), January 2023.
2. Ban KA, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017; 224(1): 59-74. 
3. Awad SS. Adherence to surgical care improvement project measures and post-operative surgical site infections. Surg Infect (Larchmt). 2012; 13(4): 234-7. 
4. Zimlichman E, et al. Health Care–Associated Infections: A Meta-analysis of Costs and Financial Impact on the US Health Care System. JAMA Intern Med. 2013; 173(22): 2039–2046. 
5. Salamone AB, et al. Synergistic Effect and Antibiofilm Activity of a Skin and Wound Cleanser. Wounds. 2020; 32(8):