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Microbial barrier properties of LiquiBandTM topical skin adhesive: an in vitro study

J McAuliffe BNurs(Hons), RN, BA(Ed) G Miller BSc (Hons)

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Microbial Barrier Properties of LiquiBandTM Topical Skin Adhesive

Objective

The purpose of this study was to demonstrate that LiquiBandTM topical skin adhesive is an effective barrier against the penetration of microorganisms while the film remains intact.

Background

Cyanoacrylate topical skin adhesives are used throughout the world for their wound closure properties in both emergency and operating room environments. Their use has increased due to the many benefits they offer both clinician and patient compared to traditional wound closure techniques such as sutures and staples. Topical skin adhesives are less invasive, faster and easier to apply, and provide similar to or improved cosmetic outcomes1. In addition to their proven use as wound closure devices cyanoacrylate skin adhesives are also selected over other methods for their microbial barrier properties. There is evidence of a clinical trend to reduced wound infection from their use2-7. CDC Guidelines8 recommend that a wound is kept covered with a sterile product for 24-48 hours post primary closure to reduce the risk of infection. They note that after this time it is unclear whether an incision needs to be covered as the body's natural healing mechanisms have commenced and provide protection from microorganisms. Topical skin adhesives, therefore, provide not only primary closure but an effective microbial barrier throughout this critical time period. LiquiBandTM topical skin adhesive, the latest of its category to gain FDA clearance in the USA, is indicated for the closure of easily approximated skin edges of wounds from surgical incisions and simple, thoroughly cleansed, trauma induced lacerations. LiquiBandTM topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches. LiquiBandTM topical skin adhesive which utilizes n-butyl cyanoacrylate is provided in a pre-assembled applicator ready for use and can be stored at ambient room temperatures. Flexibility of the adhesive is a key attribute in maintaining thin film integrity and a patent microbial barrier. LiquiBandTM topical skin adhesive has therefore been subjected to testing in accordance with ASTM 4338-97 (Flexibility Determination of Supported Adhesive Films by Mandrel Bend). LiquiBandTM resisted any form of cracking when tested on all five recommended mandrel diameters including the smallest 0.125" diameter (3mm)18.The results of this test demonstrate the potential in clinical use for LiquiBandTM topical skin adhesive to provide appropriate microbial barrier protection during the critical initial healing period.

Infection & Incidence Rates

It is difficult to quantify the levels of microorganisms found within the skin's natural flora, however, a study by Larson et al9 found the mean number of colony forming units (CFUs) on patient's skin was 229.4 on the sternum. Quantitatively, it has been demonstrated that if a surgical site is contaminated with 100,000 microorganisms per gram of tissue (>105), the risk of Surgical Site Infection (SSI) is markedly increased8. This may be much lower when foreign material (i.e. sutures, contaminated dressings) is present at the site8,10. MacLeod11 reported that just 100 staphylococci per gram of tissue introduced on silk sutures were capable of inducing infection.

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Microbial Barrier Properties of LiquiBandTM Topical Skin Adhesive

Microbial contamination of the surgical site is a necessary precursor of SSI. Surgical site infections (SSI's) are estimated to account for at least 20% of all hospital acquired infections8. It is also estimated that over 2% of all patients admitted for a surgical procedure will develop a SSI8. As a result of these infections, patient hospitalization time is extended and the overall cost of care increases by up to 2.9 times12. These infections also significantly increase the risk of more serious complications and potential death of the patient. In addition to SSIs, approximately eleven million trauma induced lacerations are treated in United States emergency rooms annually13. It follows that any device or practice which may provide a barrier to microorganism entry into the incision or trauma site, especially in the critical first 24 to 48 hour period, should be utilized to not only improve patient recovery outcomes, but also reduce the financial burden placed upon care facilities.

Test Method

In order to prove that LiquiBandTM topical skin adhesive provides a microbial barrier, a strike through test was conducted against common organisms known to cause infections (Candida albicans, Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and MRSA). In accordance with the product instructions for use, and to replicate use in the clinical environment, a thin layer (approximately 200µm*) of LiquiBandTM topical skin adhesive was applied to an agar plate containing pH sensitive dye. The skin adhesive was spread to a coverage diameter of approximately 20mm and allowed to polymerize. 10µL of challenge microorganism was pipetted onto the centre of each of the polymerized films. The plates were incubated at 30-35oC for seven days and were observed for microbial growth and colour change at 24 hours, 48 hours, 72 hours and 6 and 7 days. Pseudomonas aeruginosa was also observed at days 4 and 5 due to the motile nature of the microorganism. A total of 100 test challenges were conducted for each of the six microorganisms tested (600 total test challenges). As a result of the pH sensitive dye within the agar plate, a color change from purple to yellow would indicate penetration of the LiquiBandTM by either the challenge organism or acidic metabolic by-products. A color change was recorded as a positive result, no color change as a negative. Sensitivity control plates were also produced to demonstrate that after an incubation period of 24-48 hours just one colony forming unit (CFU) of each microorganism challenge could be detected. A negative control plate was run at the same time with 10 one drop applications to demonstrate that no extraneous contamination was introduced during preparation of the plates and loading of the LiquiBandTM topical skin adhesive.

Results/Findings

The results of this in-vitro experiment demonstrate that LiquiBandTM topical skin adhesive is an effective microbial barrier to a range of gram-positive and gram-negative motile and non-motile species as well as Candidia albicans which is a fungus. All 600 LiquiBandTM films maintained 100% patency and barrier properties after 72 hours. After seven days of challenge, 598 (99.6%) of the LiquiBandTM films prevented penetration of microorganisms into the agar. The two positive results from the six hundred challenges occurred after the 3 day time point, with one each with S.epidermidis and P.aeruginosa.

*On SEM analysis of polymerized cyanoacrylate films, the thickness was measured between the ranges of 20-250µm

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Microbial Barrier Properties of LiquiBandTM Topical Skin Adhesive

Staphylococcus aureus The study established that all one hundred films provided an effective barrier to penetration for 100% of films for 7 days when challenged with 1.45x106 cfu Staph.aureus Staphylococcus epidermidis The study established that 99 of the 100 films provided an effective barrier to penetration for 7 days when challenged with 1.08x106 cfu S.epidermidis. Microscopic examination (x100 magnification) of the film from the positive result revealed a hole in the film in the approximate location of the point of inoculation, which compromised its integrity and allowed passage of S.epidermidis. The hole was created during the manufacture of the sample and is not considered an artifact of the product itself. Candida albicans The study established that all one hundred films provided an effective barrier to penetration for 100% of films for 7 days when challenged with 1.08x106 cfu Candida albicans Escherichia coli The study established that all one hundred films provided an effective barrier to penetration for 100% of films for 7 days when challenged with 1.55 x 106 cfu E.coli. Pseudomonas aeruginosa The study established that none of the 100 films challenged with 2.03 x 106 cfu Ps.aeruginosa were penetrated after 4 days of the test period. After 5 days 1 film demonstrated a positive result. No imperfections in the film were detected on microscopic examination (x100), however the failure could not be proven to be due to penetration as Ps.aeruginosa had been observed to move over the surface of the test piece. This introduces the potential of the motile cells migrating to the periphery of the test piece. MRSA All one hundred films provided an effective barrier to penetration for 100% of films for 7 days when challenged with 1.11 x 106 cfu. Microbe ATCC Challenge (CFU) % maintaining microbial barrier properties (n = 100 tests) 3 day time 7 day time point point 100% 100% 100% 99% 100% 100% 100% 100% 100% 100% 99% 100%

Staphylococcus aureus Staphylococcus epidermidis Candida albicans Escherichia coli Pseudomonas aeruginosa MRSA

Figure 1

#6538 #12228 #10231 #8739 #9027 #43300

1.45 x 106 1.08 x 106 1.08 x 106 1.55 x 106 2.03 x 106 1.11 x 106

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Microbial Barrier Properties of LiquiBandTM Topical Skin Adhesive

Discussion

Even at very high microbial challenge levels, at least 4700 times greater than that of normal skin flora levels9, and at least 10 times greater than the number of microorganisms known to lead to infection8,10, LiquiBandTM topical skin adhesive proved to be an effective microbial barrier. This study's findings are similar to those of both Bhende et al14 and Brown15 who examined the microbial barrier properties of two other topical skin adhesive products; Dermabond® 2-octyl cyanoacrylate (Ethicon Inc.), and IndermilTM n-butyl cyanoacrylate (Tyco Healthcare) respectively. All three products have demonstrated microbial barrier properties. Bhende's study utilizing the 2-octyl cyanoacrylate skin adhesive, Dermabond®, concluded that the adhesive provided a barrier to microbial penetration of 99% efficacy for 72 hours in vitro14. In comparison to Bhende's methodology, LiquiBandTM was challenged for a longer duration of time and with a higher microbial challenge level (seven days, >105 cfu/mL). An unpublished white paper on the IndermilTM n-butyl cyanoacrylate, the same homolog as LiquiBandTM, using a similar study methodology reported that the product maintained microbial barrier patency against the same range of microbes for seven days with no failures15. Community associated MRSA has become the most frequent cause of skin and soft tissue infections presenting to emergency departments in the United States16. In the hospital setting, MRSA infections are associated with longer lengths of hospital stay, higher mortality, and increased cost16. As the latest skin adhesive to be cleared for sale in the USA, LiquiBandTM topical skin adhesive was also challenged with Methicillin-resistant Staphylococcus aureus (MRSA). Of the 100 films challenges with MRSA, all 100 demonstrated a microbial barrier after 7 days.

Conclusion

The results of this in-vitro experiment demonstrate that LiquiBandTM topical skin adhesive is an effective microbial barrier to high level challenges of gram-positive and gram-negative motile and non-motile species as well as Candidia albicans, whilst the film remains intact. Results of this and other studies suggest that use of topical skin adhesive could lead to reduced infection rates being observed in both emergency room and surgical environments.

--------------------------------------------------------------------------------------------------------------------Tests were performed for and on behalf of MedLogic Global Ltd by Agenda 1 Analytical Services Ltd, Leeds UK.

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Microbial Barrier Properties of LiquiBandTM Topical Skin Adhesive

References:

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Liebelt E. Current concepts in laceration repair. Curr Opin Pediatr. 1997:5:459-464 Howell JM, Bresnahan KA, Stair TO, Dhindsa HS, Edwards BA. Comparison of effects of suture and cyanoacrylate tissue adhesive on bacterial counts in contaminated lacerations. Antimicrob Agents Chemother. 1995 Feb;39(2):559-60 3. Quinn J, Maw J, Ramotar K, Wenckebach G, Wells G. Octylcyanoacrylate tissue adhesive versus suture wound repair in a contaminated wound model. Surgery. 1997 Jul;122(1):69-72. 4. Gristina AG, Price JL, Hobgood CD, Webb LX, Costerton JW. Bacterial colonization of percutaneous sutures. Surgery. 1985 Jul;98(1):12-9. 5. Sönmez K, Bahar B, Karabulut R, Gülbahar O, Poyraz A, Türkyilmaz Z, Sancak B, Baaklar AC. Effects of different suture materials on wound healing and infection in subcutaneous closure techniques. BENT. 2009;5(3):149-52. 6. Aksoy M, Turnadere E, Ayalp K, Kayabali M, Ertugrul B, Bilgic L. Cyanoacrylate for wound closure in prosthetic vascular graft surgery to prevent infections through contamination. Surg Today. 2006;36(1):52-6. 7. Karatepe O, Ozturk A, Koculu S, Cagatay A, Kamali G, Aksoy M. To what extent is cyanoacrylate useful to prevent early wound infections in hernia surgery? Hernia. 2008 Dec; 12(6):603-7. Epub 2008 Jun 5. 8. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, the Hospital Infection Control Practices Advisory Committee (CDC). Guideline for the prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol . 1999; 20:247-280 9. Larson EL, Cronquist AB, Whittier S, Lai L, Lyle CT, Della Latta P. Differences in skin flora between inpatients and chronically ill outpatients. Heart Lung. 2000 Jul-Aug;29(4):298-305. 10. Penhallow K. A review of studies that examine the impact of infection on the normal wound-healing process. J Wound Care, 2005;14(3):123-6 11. MacLeod J. Induction of staphylococcal infections in mice with small inocula introduced on sutures. Br J Exp Pathol 1961;42:266-77. 12. Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis [serial online] 2003 Feb [date cited]. Available at: http://www.cdc.gov/ncidod/EID/vol9no2/02-0232.htm. Accessed 11 December, 2009. 13. McCail LF. National hospital ambulatory medical care survey: 1992 emergency department summary. Vital Health Stat. 1994; 245:1-12. 14. Bhende S, Rothenburger S, Spangler DJ, Dito M. In Vitro assessment of microbial barrier properties of Dermabond® topical skin adhesive. Surgical Infections. 2002. 3(3):251-7 15. Brown L. Effectiveness of Indermil® tissue adhesive as a Microbial Barrier. Available at: http://www.covidien.com/imageServer.aspx?contentID=821&contenttype=application/pdf. Accessed 11 December, 2009. 16. Klevens M, Morrison M, Nadle J, Petit S, Gershman K, Ray S, Harrison L, Lynfield R, Dumyati G, Townes J, Craig A, Zell E, Fosheim , McDougal L, Carey R, Fridkin S. Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States. JAMA, 2007; 298(15L):1763-69 17. Data on file, MLGL. Scanning electron microscopy report . 30 June 2009. Report No: #020/033 18. Data on file, MLGL, ASTM flexibility determination, 07 January 2009. Report No: M063 VR 090

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