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

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

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Comparison of Chlorhexidine and Triclosan Anti-bacterial Soaps on Surgical Site Infections. Cheryl Barnes, Amanda Hanna, Sharon Wehr , and Michelle Wonacott. Chapter I. Surgical site infections (SSI) = approximately 500,000 per yr. - PowerPoint PPT Presentation

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

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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

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Chapter I

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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

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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).

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THEORETICAL FRAMEWORK

Joseph Lister’s Theory on the Antiseptic Principle of the Practice of Surgery

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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

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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?

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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.

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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

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Chapter II

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LITERATURE REVIEW

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Theory Literature Support

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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)

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Literature Review of Major Concepts

Twenty one sources were usedFour major concepts identified

TriclosanChlorhexidine GluconateRisk stratificationIncidence of infection in THA versus TKA

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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

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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.

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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.

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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.

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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.

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Chapter III

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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

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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.

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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

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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

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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

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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.

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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?

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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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.

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