By Carolyn Twomey, RN, BSN
Editor's note: For charts and tables, see the July print issue of Infection Control Today magazine.
Healthcare-associated infections (HAI) remain a major cause of morbidity and mortality. HAIs impose significant burdens patient pain and suffering (including adverse sequelae), patient-care time and resources, risk for patient and practitioner cross-infection, and economic consequences, to name just a few. This is not happening in a vacuum, not only is this occurring in the U.S. healthcare system but also in numerous countries across the global stage. HAIs are considered a common cause of morbidity and mortality today and are ranked high among the most common adverse events in U.S. healthcare.(1)
In 2005, the National Healthcare Safety Network, (NHSN) combined the efforts of three legacy systems at the Centers for Disease Control and Prevention (CDC), the NNIS, the National Surveillance System for Healthcare Workers (NaSH) and the Dialysis Surveillance Network (DSN). The NHSN is designed to combine voluntarily reported healthcare-associated infection data with the intent of creating a national database.(2) Through the evolution of infection control and prevention strategies, procedure-associated patient safety issues remain a top target. Surveillance systems must be able to document the prevalence and impact of HAI, monitor trends, and evaluate the efficacy of infection prevention strategies.(3)
The Patient Payment and Affordable Care Act in 2010 named Healthcare Associated Infections (HAIs) Pay for Reporting and identified the Health and Human Services target to reduce SSIs by 25 percent. The Centers for Medicare and Medicaid established "never events," among them specific HAIs, and created the concept of not reimbursing facilities for these occurrences. The Healthcare Infection Control Practices Advisory Committee (HICPAC) conducted a review of the scientific literature to evaluate the merits and limitations of HAI reporting systems which was evolving through individual states legislation and noted "HICPAC has concluded that there is insufficient evidence at this time to recommend for or against public reporting of HAI.(4) Patients vested in their healthcare and understanding the system are using public reporting of infections as a consumer decision-making tool.
The Antimicrobial Pipeline
The number of antimicrobial agents approved by the Food and Drug Administration (FDA) has sharply decreased over the last 25 years. Historically, the antimicrobial pipeline had been able to keep pace with the development of antimicrobial resistance. However, this is no longer the case. Of the 15 largest pharmaceutical companies in 2004, 1.6 percent of their drug development focus was on antibiotics.
Morbidity and Mortality Data
Reviewing the most current Morbidity and Mortality (M&M), SSI burden may well serve as the greatest driver for the need to improve and change practice as well as to drive compliance. In the U.S., approximately 300,000 SSI occur annually, they represent 17 percent of all HAI, and are second only to UTI. The mortality rate is 3 percent, and 75 percent of deaths among SSI patients are directly attributable to their SSI. Morbidity data demonstrate long-term disabilities. The length of stay (LOS) is averaged at seven to 10 additional postoperative days. The cost of SSI is noted to be in a range from $3,000 (urinary tract infection) to as much as $50,000 to $100,000 (total joint replacement infection) per patient.(8) The U.S. financial burden is estimated to be $10 billion annually.
Surgical Site Infection
Successful SSI prevention requires a bundled approach multiple strategies that when combined have a better result than any one strategy alone. This article addresses one strategy that receives very little focus as a strategy for prevention and management of SSIs surgical irrigation. Acknowledged risk factors and recognized preventive strategies for surgical site infection and identified strategies for prevention and/or management are outlined in the table, "Risk Factors and Preventive Strategies for Surgical Site Infection:"(9)
RISK FACTOR/PREVENTIVE STRATEGY
- Diabetes mellitus/Control glucose preoperatively, intraoperatively and postoperatively
- Smoking/Encourage smoking cessation 30 days prior to surgery
- Obesity/ Adjust prophylactic antibiotics by weight
- Immunosuppression/ Avoid immunosuppression if possible
- Hair removal/Use clippers (not razors) if hair must be removed
- Preoperative infection or colonization/Appropriate preoperative cleansing agents
- Inadequate surgical scrub/Enforce appropriate scrub technique/duration
- Inadequate skin prep/Enforce judicious skin prep
- Unsterilized surgical equipment/Sterilize all equipment according to published guidelines
- Operative time/Antimicrobial prophylaxis 1 hour prior to cut time
- Surgeon skill/technique/Minimize operating room traffic
Source: Sydnor ERM, Perl TM. Hospital Epidemiology and Infection Control in Acute Care Settings. Clinical Microbiology Reviews 2011;Jan:141-173.
Surgical Wound Environment
It is important to note the impact of time in the operating room has on SSI, as the duration of the surgical procedure is a risk factor for SSI. Duration of the procedure can be used to predict infection.(10) Additionally, research shows a correlation between the length of time a tray has been open and the potential for contamination. This is important for the surgical irrigant which is opened and poured into a basin early in surgery and is open to the environment throughout the surgical procedure, except in cases where bags of irrigation fluid are hung and run through a high or low pressure lavage system.
The medical literature reports microbial contamination that results in the development of a SSI almost always occurs during the interval between operative incision and closure.(11-12) An orthopedic study reported, From this data it would seem that by far the largest proportion of bacteria found in the wound, after the prosthesis, had reached it by the airborne route."(13) Furthermore, most, if not all, wounds are contaminated with microbes during the operation.(14-15) It is known most all wounds are contaminated, but many hosts immune system are able to combat the organisms without resulting in infection.(16) The fibrin matrix of the wound along with continued feedback and control mechanisms such as inflammation, along with poor collateral circulation in the immediate area of the postoperative wound create barriers to the systemically administered antibiotics.(17)
Irrigation of the surgical field is utilized to cleanse the wound bed prior to closure to promote healing.(18) The use of an antimicrobial agent to irrigate at the source of the infection seems logical.(19) However, adding antibiotics or other substances to the irrigant is a much-debated topic. In order for the irrigant additives to have any effect, the exposure time would have to be much longer than is typically seen in surgery for irrigation fluid.Nevertheless, additives such as antibiotics, antiseptics, and/or soaps have been reported.(20) Examples of antibiotics that have been used alone or in combination with others for irrigation purposes are neomycin, bacitracin, polymyxin, cefazolin, kanamycin, gentamicin and vancomycin. Antiseptics, which are also effective against bacteria, viruses and fungi, have included iodophors and chlorhexidine gluconate. Surfactants (soaps) were used historically prior to antimicrobial use.(21) Two soaps used traditionally were benzalkonium chloride and castile soap.
In a survey conducted at AORN Congress 2013, it was reported that:
Respondents reported their irrigation strategies as using:
- Normal saline (51 percent)
- Normal saline with antibiotic (35 percent)
- Povidone iodine (26 percent)
The most commonly added antibiotic was Bacitracin (57 percent)
Most participants believed Bacitracin had an indication for use in surgical irrigation (48 percent)(22)
The FDA approved label for Bacitracin does not have an irrigation indication for use(23) and cases of anaphylactic shock from Bacitracin irrigation have been reported.(24) In addition, the practice of sprinkling vancomycin powder or vancomycin in solution in a wound is gaining popularity. HICPAC made the following recommendation: the use of Vancomycin solution for topical application or irrigation should be discouraged.(25) At a time when concern is heightened about organisms resistant to all known antibiotics, this use prophylactically of what has been called a silver bullet must be questioned.
In presentations at 2012 annual meetings of both the American College of Surgeons and the Association for Professionals in Infection Control and Epidemiology (APIC), an FDA-cleared wound cleansing and debridement system with 0.05 percent chlorhexidine gluconate (CHG) for irrigation was reported. Testing of the effectiveness of 0.05 percent CHG against selective multidrug resistant (MDR) surgical pathogens in in-vitro and in-vivo analysis showed:
CHG (0.05 percent) efficacy was evaluated against Gram-positive/negative MDR isolates; in-vitro log-reduction. In-vitro analysis revealed greater than or equal to 99.99 percent log-reduction in MDR isolates (MRSA, E. faecium, K. pneumoniae, E. aerogenes, E. coli and A. baumannii) following 1-minute exposure to 0.05 percent CHG.(28)
In separate analysis, polypropylene mesh was implanted in Sprague-Dawley rats; inoculated with MRSA (3.0 log10 cfu/mL), simulating device contamination. The author concluded 0.05 percent CHG is a potent biocide resulting in a significant log-kill of selective MDR surgical pathogens. Furthermore, irrigation of contaminated (MRSA) mesh with 0.05% CHG was effective (p=0.001) in reducing the risk of device-related infection in an in-vivo animal model.(27)
Further clinical studies are warranted documenting the efficacy of this practice as an effective risk reduction strategy prior to wound closure.(27)
In additional testing, kinetic time-kill studies to demonstrate antimicrobial activity, the ability to kill bacteria and prevent re-growth showed the following:
Pseudomonas aeruginosa >99.9999%
Staphylococcus aureus MRSA (CI) >99.999%
Pseudomonas aeruginosa (CI) >99.9999%
Staphylococcus MSSA (CI) >99.999%
Klebsiella pneumonia (CI) >99.9999%
Enterococcus faecium (CI) >99.99%
Enterobacter aerogenes (CI) >99.99999%
Enterococcus faecium (CI) >99.99%
Streptococcus pyogenes (CI) >99.99%
Escherichia coli (CI) >99.9999%
Staphylococcus epidermidis >99.999%
Acinetobacter baumannii (CI) >99.9999%
Staphylococcus epidermidis (CI) >99.999%
The authors concluded, "These In-vitro log reduction studies using documented Gram-positive and Gram-negative surgical pathogens found that 0.05 percent CHG for irrigation, as a wound cleansing system, was effective in reducing microbial counts by a factor equal to or greater than 99.99 percent.(27) Finally, this system meets the American College of Emergency Physicians (ACEP) guidelines for wound irrigation volume and pressure (7-8 psi). This is important, as studies addressing high and low pressure pulse lavage report high rates of driving bacteria into bone (p<0.001), as compared to non-pulse lavage techniques.(29)
A Bundled Approach
The use of bundling -- meaning bundled evidence-based clinical practices comprised of two or more interventions or parallel strategies to attack the full cycle of infection and routes of transmission -- have been recognized30 and are now recommended by the Institute for Healthcare Improvement (IHI).(31) Bundling CHG strategies to decolonize the skin prior to admission for surgery, CHG for surgical skin preparation, surgical scrub, and CHG dressings postoperatively indicate the apparent consensus that CHG is a key tool in SSI risk reduction. Is the opportunity to potentially impact SSI by cleansing and debriding with an effective irrigation system one whose time has come?
Carolyn Twomey, RN, BSN, is vice president of clinical affairs for Irrimax Corp.
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2. Edwards JR et al. National Healthcare Safety Network (NHSN) Reports, data summary for 2006-2007, issued November 2008.
3. Sydnor ERM, Perl TM. Hospital Epidemiology and Infection Control in Acute Care Settings. Clinical Microbiology Reviews 2011;Jan:141-173.
4. McKibben L, Horan T, Tokars JI et al. Guidance on Public Reporting of Healthcare-Associated Infections: Recommendations of the Healthcare Infection Control Practices Advisory Committee. Accessed at: http://www.cdc.gov/hicpac/pubReportGuide/publicReportingHAI.html on 10 February 2012.
5. Association for Professionals in Infection Control and Prevention. HAI Reporting Laws and Regulations. States That Have Enacted Laws Related to Reporting of Healthcare-Associated Infections. Last updated 07/06/2011. Accessed at: http://www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/HAI_map.gif on 10 February 2012.
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10. AORN Periop Insider Weekly Newsletter. 27 March 2013. Accessed at:http://www.informz.net/admin31/content/template.asp?sid=8207&ptid=480&brandid=436&uid=91107922&mi=1595311&ps=8207
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23. Infection Control Today. Survey Conducted at AORN Congress Reveals Need for New and Better SSI Prevention Strategies. Accessed at: http://www.infectioncontroltoday.com/news/2013/03/survey-conducted-at-aorn-congress-reveals-need-for-new-and-better-ssi-prevention-strategies.aspx on 13 May 2013.
24. DailyMed. Bacitracin for Injection. Accessed at: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=be306d60-553d-4b8c-8aad-539da646d8e9#nlm34067-9 .
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28. Edmiston C. Department of Surgery, Surgical Microbiology Research Laboratory. Medical College of Wisconsin, Milwaukee, Wisconsin
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31. Siegel JD, Rhinehardt E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory Committee. Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006. CDC, HHS. Accessed at: http://www.cdc.gov/hicpac/pdf/guidelines/MDROGuideline2006.pdf on 11 February 2012.