Comparison of Chlorhexidine and Triclosan Anti-bacterial Soaps on Surgical Site Infections

1. Comparison of Chlorhexidine and Triclosan Anti-bacterial Soaps on Surgical Site Infections Cheryl Barnes, Amanda Hanna, Sharon Wehr, and Michelle Wonacott NURS 530 Spring 2013

2. Chapter I

3. Surgical site infections (SSI) = approximately 500,000 per yr. • 6,000-20,000 occur in patients who have had a total knee or total hip arthroplasty • Estimated economic impact of one joint infection is $100,000 in hospital costs alone for a total hip arthroplasty (THA) and $60,000 for a total knee arthroplasty(TKA) • Death occurs five times more often in patients after SSI, especially after joint replacement Background

4. Implement best practice • Assist in financial decisions for the betterment of their facility • Develop policy and protocol for non-management personnel • Oversee policy change • Enhance the quality and efficacy of nursing practice • (American Nurses Association, 2009). Role of the nurse administrator

5. Theoretical Framework Joseph Lister’s Theory on the Antiseptic Principle of the Practice of Surgery

6. Built from Pasteur’s Theory of Disease Fundamental to his proposed principles of antiseptic surgery Based on the recognition that if microbes or germs are not controlled or prevented from invading a wound, they will cause complications of infection and death.

7. Based on a review of the literature and theoretical framework, the purpose of this research is to conduct a quantitative study that will determine if there is decrease in the number of surgical site infections within thirty days of surgery when patients use 4% chlorhexidine soap for three serial washings compared to the use of antibacterial soap containing triclosan for three serial washings. Further sub-questions were generated to aid in the research design: (1) Is there a variance in the criteria physicians use when deeming patients low risk? (2) Is there a greater prevalence of one joint having more surgical site infections compared to the other? Research Questions

8. SSIs are a complication of surgery that increases morbidity for patients and significant economic burdens for health care organizations related to increased length of stay and increased cost of treatment. • Lister’s theory focus on the belief that preventing germs from entering a wound will lessen the chance of infection. • Literature has conflicting findings on which pre-operative soap is most effective in reducing entry of pathogens. • Nurse Administrators are responsible to incorporate research findings into facility policy and procedure to ensure high quality care. Chapter I Summary

9. Lister’s Theory on the Antiseptic Principle of the Practice of Surgery Destroy Germs Prevent Wound Entrance Antiseptic Solutions Showering with 4% chlorhexidine soap two days prior to surgery, one day prior to surgery, and the morning of surgery. Showering with anti-bacterial soap containing triclosan two days prior to surgery, one day prior to surgery, and the morning of surgery. Surgical Site Infections as defined by the American Academy of Orthopedic Surgeons, for 30 days post-operatively

10. Chapter II

11. Literature review

12. Theory Literature Support

13. Five sources were used to support the use of Lister’s Theory • Utilization, criticism, relevance and applicability of the theory was addressed • Overall support concludes that most everyone accepts Lister’s Theory of Antisepsis in addition to asepsis and sterile technique. Vigilance in safe aseptic practices in the operating room must be continued. (Fry, 2010) (Pitt & Aubin, 2012)

14. Twenty one sources were used • Four major concepts identified • Triclosan • ChlorhexidineGluconate • Risk stratification • Incidence of infection in THA versus TKA Literature Review of Major Concepts

15. Non-toxic, odorless, tasteless powder with antimicrobial properties • Developed in Switzerland in the1960’s • Immediate, persistent, broad spectrum antimicrobial effectiveness • Aquasept soap is a product example that uses triclosan • Found safe and effective but concern for increasing incidence of antimicrobial resistance Triclosan

16. Safe, broad spectrum antimicrobial drug that does not produce resistant organisms • Numerous studies are associated with the use of 2% versus 4% CHG, cloths versus liquid CHG and comparison of CHG to povidone iodine and other surgical cleansing agents. • Cost and compliance have also been explored • Very little is known about the value of CHG when compared to antibacterial soaps with triclosan. ChlorhexidineGluconate

17. Preoperative assessment evaluates medical problems and plans for medical management before, during and after surgery. • Main complications of most surgeries are related to cardio, pulmonary, renal, hematological, and SSIs. • Risk factors such a obesity, chronic medical conditions, and positive nasal Staph aureus are higher risk of SSI • Developing methods for lowering risks preoperatively is vital. Risk Stratification

18. Prevalence after joint arthroplasty is increasing annually • Pre-admission hygiene protocols demonstrate significant reduction in SSI • Comorbidities play a role in the increased incidence of postoperative complications such as SSI • SSI does not decrease with increased antibiotic prophylaxis • No significant clinical correlation between increased temperature and WBC count and incidence of SSI was noted. Incidence of SSI in TKA and THA

19. SSIs remain a costly and devastating complication of surgery. Studies support the incidence of this negative outcome in patients who have had either a TKA or a THA. Lister’s Antiseptic Principle of the Practice of Surgery theory supports the need to control microbial contamination in order to reduce the incidence of surgical infection. Research gaps in pre-operative screening methods and preoperative soap concentrations were identified in Chapter I. Upon completion of a major concept literature review, it is determined that research gaps still remain. These gaps include the effectiveness of CHG in reducing SSI when compared to anti-bacterial soaps with triclosan and the impact of reducing skin SA preoperatively. Chapter II Summary

20. Chapter III

21. We chose Randomized Control Trial (RCT) • Considered the gold standard for clinical trials • Found to be a highly reliable form of experimental testing with proven success rates • Also found to have high statistical power and low bias rates Research Design

22. The setting- Central Valley University Hospital, a public 800-bed not-for-profit acute care teaching hospital in Cleveland, Ohio • The population- All male and female patients over the age of 18 having an elective total hip or knee arthroplasty surgery at Central Valley University Hospitalbetween May 2013 and May 2014 • Eligibility criteria- Patients seen in the preoperative assessment center at least five business days before scheduled surgery who score less than 3 on surgical risk index • Exclusion criteria- Patients who reside at extended care facilities and patient who will be obtaining medication infused total joint prosthetics. Setting and Sample

23. Participants will be given either CHG or triclosan soap with the identical written instructions for use. • Participants will continue to be monitored for 30 days post-operatively to screen for the presence of SSI. • Use of a single blind study will be used to help eliminate bias Method

24. Interview guide for preoperative nurses to confirm compliance of preoperative hygiene • Questionnaire filled out by surgeon at 30 day follow up appointment that would indicate a SSI based on the definition that has been adopted by the American Academy of Orthopedic Surgeons • Collaboration with Infection Prevention, Admitting, and Home Care to monitor positive cultures, readmissions, and possible infection at home will take place Data Collection Instruments

25. CHG and triclosan will be provided to patients to ensure the correct product in the same strength is being used by each participant • Demonstration along with written and verbal instructions given at the preoperative assessment clinic • SRI will be used by physicians for consistency • Preoperative antibiotic protocol • Ensure standard sterile process was used during intraoperative site preparation Regulating Variables

27. Pre-operative interview questions 1. Were you able to perform all three showers with the soap according to the given instructions? 2. Did you use a clean wash cloth and towel with each shower? 3. Did you place clean sheets on your bed both nights that you showered? 4. Do you have pets? If so, did they remain off the bed after the clean sheets were placed? 5. Have you shaved any part of your body in the last 3 days? 6. Have you used any deodorant, lotion, cream, powder, or perfume today?

28. Pre-Surgical Antibiotic Protocol

29. Surgical Risk Index (SRI) Instructions: 1. One point will be assigned for each independent predictor of a major complication. 2. If total SRI is greater than or equal to 3, identify who will do preoperative assessment and inpatient medical management. Surgeon to document SRI on scheduling form. ___ High risk type of surgery includes: total joint replacement, intraperitoneal, intrathoracic, open aortic surgery, infrainguinal reconstruction surgery, major urologic and major gynecologic procedures. ___ History of heart disease (history of MI, a positive exercise test, ischemic chest pain, uncontrolled cardiac dysrhythmia, or ECG with pathological Q waves. Do not count prior coronary revascularization procedure unless one of the other criteria for ischemic heart disease is present.) ___ History of heart failure ___ History of cerebrovascular disease (CVA, TIA, high grade carotid stenosis is greater than or equal to 70%). ___ Diabetes mellitus of any type ___ Age is greater than or equal to 60 ___ GFR is less than 30 or serum creatinine is greater than 2 md/dl ___ BMI is greater than 40 ___History of severe lung disease: dyspnea on exertion, inability to perform ADLs.

30. Surgical Site Infection Definition Check the box that pertains to your patient:  A sinus tract communicating with the prosthesis; or  A pathogen is isolated by culture from two separate tissue or fluid samples obtained from the affected prosthetic joint OR Do four of the following six criteria exist:  Elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactiveprotein (CRP) concentration  Elevated synovial white blood cell (SBC) count  Elevated synovial neutrophil percentage (PMN%)  Presence of purulence in the affected joint  Isolation of a microorganism in one culture of periprosthetic tissue or fluid  Greater than five neutrophils per high-power field in five high-power fields observed from histologic analysis of periprosthetic tissue at 400 times magnification

31. Observed Frequencies Contingency Table for Chi-Square Example Data Analysis

32. Refers to the precision and statistical accuracy of the data collection instruments which the research team will be using • Surgical Risk Index • Found to be valid and reliable • Developed from a modified Goldman Cardiac Index • Original created in 1977 • Already used nationwide • Found to be highly reliable Reliability & Validity

33. Pre-Operative Interview Questions and Shower Instructions • Developed by the research team from CDC guidelines • Deemed high in reliability and validity based on IHI’s nationally published and highly reputed Guide to Surgical Site Infection for Hip and Knee Arthroplasty • Surgical Site Infection Definition • Developed from American Academy of Orthopedic Surgeon’s New Definition of Peri-prosthetic Joint Infection • Original is endorsed by the American Medical Association • Deemed high in reliability and validity Reliability & Validity

34. Study is confined to one institution • Age differences could affect the understanding of the instructions or the ability to follow through with instruction • Number of staff members involved in the different aspects of the study • Detailed guideline for a peri-prosthetic infection but does not take into account more minor wound infections • Surgeon’s choice of instrumentation and length of surgery Limitations

35. Beneficence • CHG soap poses no increased risk to the patient when compared to Triclosan soap, which is the standard treatment at this research facility • Respect for human dignity • All participiants are seen in the POAC where specially trained nurses will provide full disclosure • Participation is strictly voluntary • Justice • Participant selection will be stratified random with equal distribution • CHG will be provided for study control and to prevent discrimination of the lower socioeconomic population • Declined participation will be treated in a non-prejudicial manner and will be given Triclosan soap per standard protocol Ethical Concerns

36. There is limited research that indicates whether CHG or triclosan soap is more effective in preventing SSIs. It is therefore important to investigate this question so as to provide information that helps prevent this costly and devastating complication. An experimental quantitative randomized control study is being proposed to address which soap is more effective in reducing SSIs. In order to answer this question with reliability and validity, multiple data instruments have been developed. Study limitations such as one test site, surgeon’s choice of instrumentation, and length of surgery have been identified. However, multiple interventions will be taken to reduced limitations and ethical concerns within this proposed study. Chapter III Summary

37. If approved this study can be utilized by nurses administrators to decrease costly and devastating SSIs. This is especially important since there are penalties that reduce reimbursement for patients who obtain hospital-acquired SSIs. Conducting this study may also create the opportunity to decrease hospital length of stay and increase patient satisfaction. Pre-operative soap usage is inexpensive and straightforward compared to many other infection prevention interventions. Nursing science will benefit from this research as knowing which soap is more effective will allow nurses to act in the patient’s best interest when developing and implementing infection prevention strategies. The knowledge gained within this study will promote the implementation of evidenced based information in to the daily practice of nurses who practice within a surgical setting. Chapter III Summary cont.