Reducing the Risks with Advanced PreOp Skin Prepping

Reducing the Risks with Advanced Pre-Op Skin Prepping

The Industry Today Center for Medicare/Medicaid Services (CMS) • Payment implications began Oct. 1, 2008 • Surgical Site Infections following certain elective procedures, including certain orthopedic surgeries, and bariatric surgery • Pressure Ulcers, stage 3 and 4 • Vascular and Urinary Tract Infections from catheters • Mediastinitis • Falls • “Never Events” • VAPs Source: Federal Register, Vol. 73, No 84, August 30, 2008

The Sage Solution • Fundamental Belief in Prevention Versus Treatment • Simple, Low Cost Interventions • Documented Success as Best Practice • Focused Effort in Achieving Target Zero • Documented, Measurable Results

Interventional Patient Hygiene Bathing Risk factors for HAI’s and Early Detection of Skin Injury Incontinence Care, Heel Flotation Risk Factors for Pressure Ulcers http: //www. sageproducts. com Oral Care Risk factors for Healthcare Acquired Pneumonia Preoperative Skin Preparation Risk of Surgical Site Infection

Postoperative SSIs Magnitude of Problem • • • Approximately 60 million surgical procedures 1, 2 performed per year in the U. S. 2. 6% to 5% of surgical procedures result in surgical site infections (SSIs) 3, 4 At least 1. 5 million SSIs per year in the U. S. 5 6 Account for more than $25, 000 increase per SSI MRSA SSIs can increase costs by over $80, 0007 1. De. Frances CJ, Hall MJ, Podgornik MN, 2003 National hospital discharge survey. CDC, National Center for Health Statistics, Advance Data from Vital and Health Statistics. No. 359; 8 July 2005: 14. 2. Hall MJ, Lawrence L, Ambulatory surgery in the United States, 1996. CDC, National Center for Health Statistics, Advance Data from Vital and Health Statistics. No. 300; 12 Aug 1998: 7. 3. Mangram AJ, et al. , Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital Infection Control Practices Advisory Committee, Atlanta GA. 4. Institute for Healthcare Improvement (IHI), Topics: patient safety: surgical site infections: case for improvement. (accessed 16 Jan 2006 at http: //www. ihi. org). 5. Figure calculated by multiplying SSI rate from ref. #3 by surgical procedure numbers from ref. #1 and #2. 6. Stone PW, et al. , Am J Infect Control. Nov 2005; 33(9): 501 -9. 7. Engemann JJ, et al. , Clin Infect Dis 1 Mar 2003; 36 (5): 592 -8

THE BIRTH OF SURGICAL SKIN ANTISEPSIS

Bacteria E. Coli MRSA Staph Aureus

Prepping the Patient’s Skin “…great precautions have been taken to get the region absolutely sterile. We have begun three days before by shaving and cleansing the region of the operations. This was repeated on the second and third days. Then the patient was brought to the operating room. . . ” -Excerpt from Joseph Lister’s “Germ Theory, ” Circa 1895 Lehrer S, Explorers of the Body: Dramatic Breakthroughs in Medicine from Ancient Times to Modern Science. 2 nd Ed. , Universe, Inc. Lincoln NE. 2006: 136 -140.

Surgery Now Then

From a Hospital’s Perspective: • Un-reimbursable cost • Lost revenues • Surgical reputation • Preventable medical error • Mandatory reporting is here • Growing legal liability

From Patient’s Perspective: • Very unexpected event • Back to the hospital • Pain and discomfort • Significant co-morbidity • Increased length of • Twice as likely to die stay

SSI Prevention “The vast majority of postoperative incisional or superficial wound infections are caused by microorganisms normally found on the patient’s skin…” 1 “Preoperative skin preparation, using an antiseptic agent, when done correctly, has been shown to effectively reduce both transient and resident skin flora, as well as infection rates. ” 2 1. Tietjen L, et al. , Infection Prevention Guidelines for Healthcare Facilities with Limited Resources. JHPIEGO Corporation, Baltimore MD. March 2003: Ch. 6 -1. 2. Platt J, Bucknall RA, J Hosp Infect 1984; 5(2): 181 -188.

#1 Goal: Address a Known Risk Factor for SSIs Reduce the microorganisms on the patient’s skin. Initiate a simple comprehensive approach for skin antisepsis.

Professional Guidelines • CDC - Strongly Recommended (Category 1 B) that patients shower with an antiseptic agent before undergoing an elective surgical procedure. • 2008 AORN Guidelines for Preoperative Skin Antisepsis Patients undergoing open class I surgical procedures below the chin should have two (2) preoperative showers with CHG before surgery, when appropriate. • SHEA/IDSA Compendium: SSI Prevention Practice Recommendation - To gain maximum antiseptic effect of Chlorhexidine, it must be allowed to dry completely and not be washed off.

Class 1 Procedures (Below the Chin) ACL Reconstruction Class I Arthroscopy (Knee, Shoulder, Elbow) Class I Bilateral Tubal Ligation (BLT) Open Class I Breast Reduction, Implant, Biopsy Class I Bunionectomy Class I Cardiac Surgery Class I C-Section Class I Carpal Tunnel Release Class I Cystectomy - Class is based on the location of the cyst; if abdominal Class I Exploratory Laproscopy - the alimentary tract, bowel or GU Tract is NOT entered Class I Hernia (inguinal, ventral, umbilical, etc. ) Class I Hip replacement Class I Hydrocelectomy Class I IOL (PHACO) Class I Joint Replacement Class I Source: Section 10 B, Surgical Classifications, http: //www. dewitt. wramc. amedd. army. mil

Class 1 Procedures (Below the Chin) Laparotomy (does not enter the bowel) Class I Lumpectomy Class I MRM Class I Mammoplasty reduction Class I Mastectomy Class I Myomectomy Class I Nephrectomy Class I ORIF-elective, not immediately after trauma/no open wounds or infection pre-op Class I Orthopedic (not after blunt trauma) Class I Osteotomy Class I Splenectomy Class I Tubal reversal Class I Vascular surgery (Femoral-popliteal bypass, Arterial-femoral bypass, vein-stripping) Class I Source: Section 10 B, Surgical Classifications, http: //www. dewitt. wramc. amedd. army. mil

Why Chlorhexidine Gluconate (CHG)? Pre-op skin prepping with CHG • CHG is persistent, active for up to 6 hours 1 • Literature shows repeat applications will maximize antimicrobial effect 2 • CHG has rapid bactericidal action 3 • Only skin antiseptic with “excellent” activity against gram-positive as well as “excellent” residual activity 4 1. Larson E, APIC guidelines for infection control practice: guideline for use of topical antimicrobial agents. Am J Infect Control. 1988; 16(6): 253 -65. 2. Paulson D, Am J Infect Control. 1993; 21: 205 -9. 3. Denton GW, Chlorhexidine. In Seymour S. Block (Ed. ) Disinfection, sterilization, and preservation. 4 th Ed. , Lea & Febiger, Williams & Wilkins, Media PA, 1991: 279. 4. Mangram AJ, et al. , Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention, Hospital Infection Control Practices Advisory Committee, Atlanta GA.

The Sage Solution Patient Skin Prepping with 2% CHG Cloth • • Only FDA-Approved cloth delivery of CHG Unique 2% CHG formulation – – – Fast-acting and broad spectrum Alcohol- free and rinse-free Persistent and cumulative http: //www. sageproducts. com/products/ssi-prevention. cfm • • Built in compatibility Delivery system: onestep applicator cloth – – Provides a uniform dose of CHG No drips, runs or pooling Large cloth to prep body contours Allows solution to penetrate sebaceous glands

Features & Benefits 500 mg CHG (per cloth) - Delivers uniform dose of CHG to skin - No mixing or product ratios to remember. 100 % Polyester Non-Abrasive Cloth - Gentle, yet effective friction removes debris and organic matter. - No drips, runs, or pooling. - CHG binds to proteins of skin, as well as proteins of cotton washcloths Large 7. 5 in by 7. 5 in size - Easier to prep hard to reach areas, body contours, and skin folds. Broad Spectrum - Effective against a wide range of microorganisms. - Includes MRSA, VRE, Acinetabactor Extremely Persistent - Demonstrates continues antimicrobial activity for up to 6 hrs. - Active in the presence of blood and organic matter. - Provides cumulative effect with multiple applications.

Features & Benefits Contains No Alcohol or Harsh Detergents - Reduces potential to dry out skin. - Eliminates flammability concerns. Rinse-Free and Skin Friendly - Only rinse-free CHG product in a cloth. - Contains surfactants to loosen dirt and debris. - Softens skin with moisturizers (Aloe Vera, Vitamin E, Dimethicone). Clear Solution - No skin staining. - Allows for easier site assessment. Package Options & Prep-Check Compliance Tool - Helps to manage compliance. ADDRESSES THE #1 RISK FACTOR FOR SSI Bacteria On The Patients Own Skin!

Points of Difference 2% CHG Cloth vs Other CHG Methods • • Antiseptic dilution or rinsed off early Patient compliance is a major problem Delivery systems Getting the antiseptic to the site CHG “binding” to cotton & not releasing to skin Inactivated by hard water Not achieving FDA testing Prep Check communication and compliance tool

Prep Check and Compliance http: //www. sageproducts. com/education/chg. Template. asp

Sage 2% CHG Cloth Studied

Chlorhexidine Wipes: The New Weapon Against SSI’s? Patricia O’Malley, Clinical Nurse Specialist Journal – March 2008 Key Findings: 1. Skin preparation reduces risk of SSI. 2. CHG destroys cell membrane – prevents resistance. 3. 2% CHG Cloth vs. 4% CHG Solution: For every FDA testing period (10 min, 20 min, 6 hours) microbial counts were significantly less for areas treated with 2% CHG Cloth “Chlorhexidine Wipes: The New Weapon Against Surgical Site Infections? ”; O’Malley P; Clin Nurs Spec; March 2008

SSI Reduction in Ortho Patients Deb Eiselt, Lakeview Hosp, MN, APIC 2007 Poster – – Ortho patients receiving total joint replacement Application times: night before & morning of From betadine to 2% CHG Cloths Results: • 50% reduction • Improved compliance Presurgical Skin Preparation with a Novel 2% Chlorhexidine Gluconate (CHG) Cloth Leads to Decrease in Surgical Site Infection Rates in Orthopedic Surgical Patients; Eiselt D http: //www. sageproducts. com/education/chg. Symposia. Pres. asp

Reducing Surgical Site Infections Henry Rhee, MD & Bonnie Harris, Prince Williams Hosp, IHI Poster, Dec. 2007 – No standardized pre-op body cleansing protocol – 2% CHG Cloths used housewide – Patients instructed in pre-op – Application, neck down – Results: • > 60% SSI reduction • 10 -month ROI > $348 K Preoperative Skin Preparation Protocol Results in Reduced SSI Rates Henry Rhee, MD, Chair Infection Control Committee and Bonnie Harris, CIC, Infection Control Practitioner: presented at Institute for Healthcare Improvement (IHI), Orlando, FL, December 2007 http: //www. sageproducts. com/education/chg. Symposia. Pres. asp

Clinical Studies Re-Cap O’Malley 1. 2. 3. 4. Skin preparation reduces risk of SSI. CHG destroys cell membrane – prevents resistance. Cochrane found no evidence to support SSI reduction with pre-op shower. 2% CHG Cloth vs. 4% CHG Solution: For every FDA testing period (10 min, 20 min, 6 hours) microbial counts were less for areas treated with 2% CHG Cloth significantly Eiselt 1. 2. 3. 4. 5. Microorganisms implicated in SSI’s come from patients skin Betadine - 3. 19% SSI Rate 2 % CHG Cloth - 1. 59% SSI Rate 50% reduction in SSI’s Ease of use drove patient compliance Rhee & Harris 1. 2. 3. 4. 5. SSI’s cost hospitals money - $25, 546 (mean) per SSI & $92, 363 (mean) per MRSA SSI’s No Pre-op skin prep protocol (10 Months) - 25 SSI’s Full body pre-op skin prep protocol (10 months) - 11 SSI’s ROI = $348, 923 No other SSI prevention measures were implemented

SSI Goal - Target Zero Barb Livingston, VA Des Moines, APIC 2007 Poster – Problem: accessing 4% CHG solution through pharmacy, poor staff and patient compliance – Solution: 2% CHG Cloths, night before and morning of • Instructions provided, compliance increased • Ease of application • IHI bundle also implemented • From 0. 2% to 0. 0% in 1 yr Challenges and Experience with Implementing Patient Preoperative Skin Preparation in a Veterans Administration (VA) Health System to Prevent Surgical Site Infections; Livingston http: //www. sageproducts. com/education/chg. Symposia. Pres. asp

Exceeding FDA Testing • • • FDA design criteria for evaluating preoperative skin preparations was used, measuring log reductions at 10 min, 30 min, and 6 hours post application. Inguinal Sites (FDA Criteria 3 Log Reduction) Abdominal Sites (FDA Criteria 2 Log Reduction) Results: 2% CHG Cloth exceeded FDA criteria for log reductions in Inguinal & Abdominal sites. Results: 4% CHG Solution FAILED to meet FDA log reduction criteria in Inguinal sites. Comparison of a New and Innovative 2% Chlorhexidine Gluconate (CHG) Impregnated Preparation Cloth with the Standard 4% CHG Surgical Skin Preparation. Edmiston C, Seabrook GR, Johnson CP, et al. Poster presented at the 2007 Association of peri. Operative Registered Nurses (AORN) Congress, Orlando, FL Mar 2007 http: //www. sageproducts. com/education/chg. Symposia. Pres. asp

Getting Started • • What’s your current practice? ü Pre-op prep? ü Final prep? Does it follow CDC, AORN & SHEA recommendations? ü Category 1 B recommendation ü Night before & morning of surgery ü Allowed to dry on skin How is compliance to protocol? ü Patient compliance level? What is your dual-delivery system? ü CHG product getting to patient? ü CHG getting to skin?

Delivering Value Determine your "break-even" number – Hospital has 5, 000 surgeries – 5, 000 x 2 x $6. 00 = $60, 000 per year – Only need to prevent three SSIs to break even – 0. 06% – Additional SSIs avoided go to hospital bottom line

Impact Tools for Implementation • Implementation Plan – – – Surgeon’s office Hospital pharmacy Gift shop Hospital admissions Pre-op screening Pre-op holding • Product Announcement Letter • Announcement Posters • Instruction Templates

Web Pulls it All Together

Implementation Tips • Keep product centralized in areas where they will have a lot of volume • Tell preoperative holding areas not to reload the warming units on Fridays if they will be closed on the weekends • Do not overload the warmers • Shower • Shaving / clipping • Application time

Thank You For Your Time