Comparison of Chlorhexidine and Triclosan Anti-bacterial Soaps on Surgical Site Infections
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Transcript of Comparison of Chlorhexidine and Triclosan Anti-bacterial Soaps on Surgical Site Infections
NURS 530 Spring 2013
Comparison of Chlorhexidine and
Triclosan Anti-bacterial Soaps on Surgical Site
Infections
Cheryl Barnes, Amanda Hanna, Sharon Wehr,
and Michelle Wonacott
Chapter I
Background
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
Role of the nurse administrator
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).
THEORETICAL FRAMEWORK
Joseph Lister’s Theory on the Antiseptic Principle of the Practice of 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.
Built from Pasteur’s Theory of Disease
Fundamental to his proposed principles of antiseptic surgery
RESEARCH QUESTIONS
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?
Chapter I Summary
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.
Lister’s Theory on the Antiseptic Principle of the Practice of Surgery
Destroy Germs
Prevent Wound Entrance
Antiseptic Solutions
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 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.
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
Surgical Site Infections as defined by the American Academy of Orthopedic Surgeons, for 30 days
post-operatively
Chapter II
LITERATURE REVIEW
Theory Literature Support
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)
Literature Review of Major Concepts
Twenty one sources were usedFour major concepts identified
TriclosanChlorhexidine GluconateRisk stratificationIncidence of infection in THA versus TKA
Triclosan
Non-toxic, odorless, tasteless powder with antimicrobial properties
Developed in Switzerland in the1960’s Immediate, persistent, broad spectrum antimicrobial
effectivenessAquasept soap is a product example that uses triclosanFound safe and effective but concern for increasing
incidence of antimicrobial resistance
Chlorhexidine Gluconate
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 exploredVery little is known about the value of CHG when
compared to antibacterial soaps with triclosan.
Risk Stratification
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.
Incidence of SSI in TKA and THA
Prevalence after joint arthroplasty is increasing annuallyPre-admission hygiene protocols demonstrate significant
reduction in SSIComorbidities play a role in the increased incidence of
postoperative complications such as SSISSI does not decrease with increased antibiotic
prophylaxisNo significant clinical correlation between increased
temperature and WBC count and incidence of SSI was noted.
Chapter II Summary
• 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 III
Research Design
We chose Randomized Control Trial (RCT) Considered the gold standard for clinical trialsFound to be a highly reliable form of experimental testing
with proven success rates Also found to have high statistical power and low bias
rates
Setting and Sample
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 Hospital between 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.
Method
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
Data Collection Instruments
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
Regulating Variables
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 consistencyPreoperative antibiotic protocolEnsure standard sterile process was used during
intraoperative site preparation
Pre-Operative Shower Instructions
Before surgery it is important that your body be clean to reduce your risk for infection. Please follow the steps below using the soap provided.
1. You will take a series of three showers using the soap provided. Shower #1 should be taken two nights before your surgery, shower #2 should be taken the night before your surgery, and shower #3 should be taken the morning of your surgery. Here is an example: If your surgery is on Wednesday, you will take showers Monday night, Tuesday night, and Wednesday morning.
2. Wash your hair and face first with your normal shampoo and soap. Then use the provided soap from the neck down. Do not use your home soap after the medicated soap.
3. Brush your teeth each day especially the day of surgery. Dentures should be cleaned as well as your mouth.
4. Use a clean wash cloth and towel each time you shower. 5. Dress in freshly washed clothes after each shower. 6. Fresh sheets and pillowcases should be used after showering. Keep all animals off the
bed once you have placed the clean sheets. 7. Do NOT shave legs, underarms, or any part of your body three days prior to surgery.
Men may shave their face. 8. Do NOT apply any deodorant, lotions, creams, powders, or perfumes the day of surgery.
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?
Pre-Surgical Antibiotic Protocol
Type of Orthopedic SurgeryPreferred
Antibiotic/Dose/RouteAlternative if allergy to
preferred antibiotic
Orthopedic:If surveillance culture is positive for MRSA Hips, Knees and Long Bones Orthopedic procedures not using an implanted device
Vancomycin 1 gram IVPB + Cefazolin 2 gram IV push Cefazolin 2 gram IV push Cefazolin 2 gram IV push
Vancomycin 1 gram IVPB + Gentamicin 1.5 mg/kg IVPB Vancomycin 1 gram IVPB + Gentamicin 1.5 mg/kg IVPB Clindamycin 900 mg IVPB
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.
Surgical Site Infection DefinitionCheck 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
ORDo 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
Data Analysis
Triclosan Soap
(Control Group)
CHG Soap
(Intervention Group)
Total
SSI - Yes a b a + b
SSI - No c d c + d
Total a + c b + d a + b + c + d = N
(N=total sample
size)
Observed Frequencies Contingency Table for Chi-Square Example
Reliability & Validity
• Refers to the precision and statistical accuracy of the data collection instruments which the research team will be using
• Surgical Risk Indexo Found to be valid and reliableo Developed from a modified Goldman Cardiac Index
Original created in 1977 Already used nationwide Found to be highly reliable
Reliability & Validity
• Pre-Operative Interview Questions and Shower Instructionso Developed by the research team from CDC guidelineso 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 Definitiono Developed from American Academy of Orthopedic Surgeon’s
New Definition of Peri-prosthetic Joint Infection o Original is endorsed by the American Medical Associationo Deemed high in reliability and validity
Limitations
• 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
Ethical Concerns
• Beneficenceo 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 o All participiants are seen in the POAC where specially trained nurses
will provide full disclosure o Participation is strictly voluntary
•Justiceo Participant selection will be stratified random with equal distributiono CHG will be provided for study control and to prevent discrimination
of the lower socioeconomic populationo Declined participation will be treated in a non-prejudicial manner and
will be given Triclosan soap per standard protocol
Chapter III Summary
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 cont.
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.
References
Chalkidoua, K., Tunisb, S., Whicherb, D., Fowlerc, R., & Zwarensteinc, M. (2012). The role
for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness
research. Clinical Trials, 9, 436-446. doi: 10.1177/1740774512450097
Chi-Square. (2013). Retrieved from
http://www.okstate.edu/ag/agedcm4h/academic/aged5980a/5980/newpage28.htm
Choice of statistical techniques. (2013). Retrieved from
http://www.unesco.org/webworld/idams/advguide/Chapt1_5.htm
Daily chlorhexidine gluconate (CHG) bathing for adult patients. (2013). Retrieved from
http://www.uwhealth.org/healthfacts
Ethics in clinical research. (2011). Retrieved from http://clinicalcenter.nih.gov/recruit/ethics.html
Fleischer, L.A., Beckman, J.A., Brown, K.A., Calkins, H., Chaicof, E., Fleischmann, K. &
Robb, J.F. (2007). ACC/AHA 2007 guidelines on perioperative cardiovascular
evaluation and care for noncardiac surgery: Executive summary: A report of the
American College of Cardiology/American Heart Association Task Force on practice
guidelines. Journal of the American College of Cardiology, 50, 1707-1732.
doi: 10.1016/j.jacc.2007.09.001
Goldman, L., Caldera, D., Nussbaum, S., Southwick, F., Krogstad, D., Murray, B., Burke, D.,
& O’Malley, T. (1977). Multifactorial index of cardiac risk in noncardiac surgical
procedures. New England Journal of Medicine, 297, 845–850.
doi:10.1056/NEJM19771020297160
Healey, J.F. (2011). Statistics: A tool for social research. Independence, KY: Cengage
Learning.
Institute for HealthCare Improvement (2012). How to guide: Prevent surgical site infection for
hip and knee arthroplasty. Retrieved from http://www.ihi.org/knowledge/Pages/Tools/
HowtoGuidePreventSSIforHipKneeArthroplasty.aspx.
Kendall, J.M. (2003). Designing a research project: Randomized controlled trials and their
principles. Emergency Medicine Journal 20(2), 164-168.
Parvizi, J. (2011). A new definition for periprosthetic joint infection. American Academy of
Orthopedic Surgeons. Retrieved from http://www.aaos.org/news/aasonow/nov1
Polit, D.F., & Beck, C.T. (2012). Nursing research: Generating and assessing evidence for
nursing practice (9th ed.). Philadelphia, PA: Wolters-Kuper Health.
Research ethics. (1998). Retrieved from http://depts.washington.edu/bioethx/topics/resrch.html
Ritz, J., Pashnik, B., Padula, C., & Simmons, K. (2012). Effectiveness of 2 methods of
chlorhexidine bathing. Journal of Nursing Care Quality, 27(2), 171-175.
Swick, A., Makani, A., Wu, C., O’Donnell, J., Baldwin, K.D., & Lee, G.C. (2012). Does dual
antibiotic prophylaxis better prevent surgical site infections in total joint arthroplasty?
Clinical Orthopedics and Related Research, 470, 2701-2707. doi: 10.1007/s11999-012-
2255-1
The chi square statistic. (2013). Retrieved from
http://math.hws.edu/javamath/ryan/ChiSquare.html
United States Centers for Disease Control. (2013). Surgical site infection event. Retrieved from
http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf?agree=yes&next=Accept
Utts, J. M., & Heckard, R. F. (2006). Mind on statistics (3rd ed.). Belmont, CA: Thomson
Brooks/Cole Corporation.
Whiteside, L., Nayfeh, T., LaZear, R., & Roy, M. (2012). Reinfected revised TKA resolves with
an aggressive protocol and antibiotic infusion. Clinical Orthopedics and Related
Research, 470. 236–243. doi: 10.1007/s11999-011-2087-4
Wood, M.J., & Ross-Kerr, J.C. Basic steps in planning nursing research (7th ed.).
Sudbury, MA: Jones and Bartlett.