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Establishing a Culture of Safety:
     Working Toward Zero
        Orthopedic SSIs

  Maureen Spencer, RN, M.Ed, CIC
  Infection Preventionist Consultant
             Boston, MA


    Email: maureen_spncr@yahoo.com
      www.workingtowardzero.com
     www.creativehandhygiene.com
Example of Working Toward Zero Team Members
 The teams:
     Surgical Site Infections: Director Surgical Services, OR Manager, SPD Director, Infection
      Control Manager, Two Surgeons, VP Patient Care Services, Director of Nursing, Nursing
      Manager, Clinical Educator, Microbiology Lab Director

     Ventilator Associated Pneumonia: ICU Hospitalist, ICU Nurse Manager, ICU Nurse, Director of
      Anesthesia, ICU Clinical Educator, Respiratory Therapy, Infection Control Manager, Micro Lab

     Central Line Assoc Bloodstream Infections: Surgeon who inserted most central lines, ICU
      Manager, Director of Anesthesia, ICU Clinical Educator, ICU Nurse, Infection Control Manager

     Catheter Assoc UTI: Clinical Educator, Infection Control Manager, Chief Urology, Lab Director

     MRSA Elimination: Infection Control Manager, Pre-admission testing, OR Director,
      Microbiology Lab Director, Two Surgeons, Director of Nursing, Patient Access Director,
     Information Technology, ID physician

     C.difficile: Chiefs of Surgery and Gastroenterology, ICU Nurse Manager, Micro Lab Director,
      Infection Control Manager

2
Post-op:
                                      Irrigation?         Incisional            Patient
                                                          adhesive should       education is
                                      Consider using      be the number         extremely
                    Intraoperative:   saline or new       one consideration     important since
                    CHG/alcohol       CHG (0.05%)         for wound             many patients
                    skin prep,        irrigant and        closure –             are discharged
                    antibacterial     eliminate           prevents              early in the
Pre-op:             sutures,          expensive and       dehiscence and        post-op period
                    incisional        toxic               exogenous             and have
Screen for MRSA                       bacitracin/polymi
and Staph aureus    adhesive                              contamination to      incisions that are
                                      xin or antibiotic   wound                 in the exudative
CHG pre-op                            irrigant
shower or cleanse                                         If not used           state of wound
with impregnated                                          consider covering     healing
cloths                                                    incision for length
Assure OR meets                                           of hospitalization
AORN standards of
practice
MRSA and Staph aureus
                   Elimination Program Before Patients Enter
                            the Hospital for Surgery

                                      Prescreening Process
                               Topical Decolonization Protocol
                                   Vancomycin for MRSA




1. Kim D, Spencer M, Davidson S, et al. J Bone Joint Surg 2010;92:1820-6
2. Spencer M, Kim D, et al: AAOS, 2010
4
Provided Evidence: February 2006
      Anonymous Nares Cultures To Prove to Administration Patients Are Colonized
                           With Staph aureus and MRSA

    N = 133 patients anonymously surveyed and
      cultured in OR after anesthetized

    Purpose: to determine pre-op MRSA and Staph
      aureus colonization rates for administration

    Results:
      38 – Staph aureus        (29%)
      *5 - MRSA                ( 4%)

      *all undiagnosed, no precautions used in OR,
       PACU, postop nursing unit
      *MRSA cases received Cefazolin for surgical
5      prophylaxis – THE WRONG ANTIBIOTIC!
Implemented Decolonization Protocol

    • 5-day application of intranasal 2% mupirocin -
      applied twice daily - for MRSA and Staph aureus
      positive patients
      • Prescription called in by Nurse Practitioner in
         prescreening unit
    • Daily body wash with chlorhexidine (purchased
      by patient)
    • MRSA Patients – Unique sticker system to notify
      Pre-surgery Unit of Vancomycin surgical
      prophylaxis



6
7
Pre-op MRSA and S. aureus Decolonization

     Results:

       Timeframe: July 17, 2006 through September 2010

       Infection rate:      20,065 patient screened

                             5,988 (23%)        positive for Staph aureus
                             1,027 ( 4%)        positive for MRSA

       Effectiveness:       Repeat nasal screens on MRSA patients
                             revealed 77% eradication




8
Pre-op MRSA and S. aureus Decolonization
     Results: % MRSA and S. aureus SSI
                              Inpatient         # of Surgical
           Time Period                                          %MRSA/MSSA
                              Surgeries          Infections
    FY06
    10/01/05-07/16/06*          5,293*              24*           0.45%*
                         *Historical Controls
    FY07
    07/17/06-09/30/07            7,019               6             0.08%

    FY08
    10/01/07-09/30/08            6,323               7             0.11%

    FY09
    10/01/08-09/30/09            6,364               11            0.17%

    FY10
    10/01/10-09/30/10            6,437               6             0.09%


9
Pre-op MRSA Decolonization
   Results: % MRSA SSI in Screened Patients
                                         Inpatient          # MRSA                        #Infect/#MRSA
          Time Period                                                        MRSA%
                                         Surgeries            SSIs                               +
 FY06
 10/01/05-07/16/06                          5,293            10 (NA)              0.19%         NA

 FY07
 07/17/06-09/30/07                          7,019             3 (3+)              0.04%   3/309 (0.97%)

 FY08
 10/01/07-09/30/08                          6,245             4 (2+)              0.06%   2/242 (0.83%)

 FY09
 10/01/08-09/30/09                          6,336            6* (2+)              0.09%    2/234 (0.85%)

 FY10
 10/01/10-09/30/10                          6,437             1 (1+)              0.01%    1/266 (0.37%)

 * isolates have been sent for pulse field gel electrophoresis
10 5 of the 6 isolates were available for PFGE and were not related genetically
Pre-op Staph aureus Decolonization

      Results:          % S. aureus (MSSA) SSI in Screened Patients
                                 Inpatient   # MSSA              #Infect/#MSSA
          Time Period                                  MSSA%
                                 Surgeries     SSIs                     +
     FY06
     10/01/05-07/16/06             5,293     14 (NA)    0.26%             NA

     FY07
     07/17/06-09/30/07             7,019     3 (3+)     0.04%    3/1588    (0.19%)

     FY08
     10/01/07-09/30/08             6,245     3 (1+)     0.05%    1/ 1422   (0.07%)

     FY09
     10/01/08-09/30/09             6,336     5 (1+)     0.08%    3/1403    (0.21%)

     FY10
     10/01/10-09/30/10             6,437     6 (1+)     0.09%    1/1450    (0.06%)

11
OR Risk Factors:
         Contamination from OR Staff
     • Reviewed orderlies and room turnover procedures

     • Improved traffic control
        – new signage and monitoring system
        keep room doors closed and minimize traffic

     • Eliminate surgical caps – do not cover hair!
     • Cloth cap use – if worn, must be covered in OR room
       with disposable cap - hair coverage monitored
       – Hair harbors organisms
       – Staff sweat in cloth caps
       – How often do they get washed? Hospital laundered
       – Where are they stored?
       – Would you eat a meal with hair in it?
           – Why allow hair to potentially fall into
                  surgical incisions?
12
OR Risk Factors:
     Cleaning/Sterilization of Instruments
 • Inspection of Orthopedic Instruments
     – Lumens, grooves, sorting, hand cleaning,
       disassembly required – massive kits
     – Many instruments cannot be disassembled


 • Instituted better pre-soaking and rinsing of
     tissue and blood from the instruments in the
     operating room before decontamination

 • There was a recent outbreak investigated by
     CDC of shoulder infections - found shavers and
     cannulas with biofilm and tissue observed inside
     instruments with small camera

13
Pathogens survive on surfaces
                                Organism                                            Survival period
    Clostridium difficile                                                          35- >200 days.2,7,8
    Methicillin resistant Staphylococcus aureus (MRSA)                            14- >300 days.1,5,10
    Vancomycin-resistant enterococcus (VRE)                                        58- >200 days.2,3,4
    Escherichia coli                                                               >150- 480 days.7,9
    Acinetobacter                                                                 150- >300 days.7,11
    Klebsiella                                                                     >10- 900 days.6,7
    Salmonella typhimurium                                                        10 days- 4.2 years.7
    Mycobacterium tuberculosis                                                         120 days.7
    Candida albicans                                                                   120 days.7
    Most viruses from the respiratory tract (eg: corona,                               Few days.7
    coxsackie, influenza, SARS, rhino virus)
    Viruses from the gastrointestinal tract (eg: astrovirus, HAV,                     60- 90 days.7
    polio- or rota virus)
    Blood-borne viruses (eg: HBV or HIV)                                                >7 days.5
1. Beard-Pegler et al. 1988.. J Med Microbiol. 26:251-5.       7. Kramer et al. 2006. BMC Infect Dis. 6:130.
2. BIOQUELL trials, unpublished data.                          8. Otter and French. 2009. J Clin Microbiol. 47:205-7.
3. Bonilla et al. 1996. Infect Cont Hosp Epidemiol. 17:770-2   9. Smith et al. 1996. J Med. 27: 293-302.
4. Boyce. 2007. J Hosp Infect. 65:50-4.                        10. Wagenvoort et al. 2000. J Hosp Infect. 45:231-4.
5. Duckworth and Jordens. 1990. J Med Microbiol. 32:195-200.   11. Wagenvoort and Joosten. 2002. J Hosp Infect. 52:226-7.
6. French et al. 2004. ICAAC.
Why Better Environmental Cleaning?
               Prior room occupancy increases risk
Study                         Healthcare associated pathogen              Likelihood of patient acquiring HAI
                                                                          based on prior room occupancy
                                                                          (comparing a previously ‘positive’
                                                                          room with a previously ‘negative’
                                                                          room)
Martinez 20031                VRE – cultured within room                                   2.6x
                              VRE – prior room occupant                                    1.6x
Huang 20062
                              MRSA – prior room occupant                                   1.3x
                              VRE – cultured within room                                   1.9x
                              VRE – prior room occupant                                    2.2x
Drees 20083
                              VRE – prior room occupant in previous two
                                                                                           2.0x
                              weeks
Shaughnessy 20084             C. difficile – prior room occupant                           2.4x
                              A. baumannii – prior room occupant                           3.8x
Nseir 20105
                              P. aeruginosa – prior room occupant                          2.1x
1.   Martinez et al. Arch Intern Med 2003; 163: 1905-12.
2.   Huang et al. Arch Intern Med 2006; 166: 1945-51.
3.   Drees et al. Clin Infect Dis 2008; 46: 678-85.
4.   Shaughnessy. ICAAC/IDSA 2008. Abstract K-4194.
5.   Nseir et al. Clin Microbiol Infect 2010 (in press).
Rates of Surface Contamination (in hospitals) with MSRA,
VRE, and C. Difficile
 Blood Pressure
 Cuff:                                                                                                                                                                   Windowsill:
 VRE 14%                                                                                                                                                                 C. Difficile 33%

                                                                                                                                                                         Commode:
 Overbed Table:
                                                                                                                                                                         C. Difficile 41%
 MRSA 40%
 VRE 20%                                                                                                                                                                 Patient Gowns:
                                                                                                                                                                         MRSA 51%
 Bedrail:
 MRSA 29%                                                                                                                                                                Floors:

 VRE 28%                                                                                                                                                                 MRSA 55%

 C. Difficile 19%                                                                                                                                                        C. Difficile 48%

 Bedsheets:
 MRSA 53%
                               Did you know that every time you get a new roommate, there is an
 VRE 40%
                               increase of 3-10% that you will acquire an HAI.
  Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med.
  2006 Oct 9;166(18):1945-51
 Boyce J.M. et al.: Environmental contamination due to methicillin-resistant Staphylococcus aureus: Possible infection control implications. Infect Control Hosp Epidemiol 18:622-627, Sep. 1997.
 Slaughter S., et al.: A comparison of the effect of universal use of gloves and gowns with that of glove use alone on acquisition of vancomycin-resistant enterococci in a medical intensive care
 unit. Ann Intern Med 125: 448-456, Sep 15, 1996.
 Samore M.H., et al.: Clinical and molecular epidemiology of sporadic and clustered cases of nosocomial Clostridium difficile diarrhea. Am J Med 100:32-40, Jan. 1996.
Environmental Disinfection – Joint
     Commission and CMS Focus on Surveys
  Developed cleaning schedules for Patient Care
     Services – what equipment, how
     cleaned/disinfected, how often, by who, contact
     times for disinfectants?

  Eliminate dirty buckets of water and string mops
    institute micro fiber cloths and mops
    Assure staff know proper cleaning technique:
         left to right, high to low, clean to dirty with
           competencies

  Daily check sheet for terminal cleaning of OR at
     night and for all precaution cases



17
Decontamination of Portable Equipment
           with Contracted Services

            Ultrasonic scrub
              Movable carts
              Tables
              Poles
              Small equipment
            1500 pieces cleaned
              OR, radiology, nursing
            Cost: ~$20,000 / year

     APIC 2005 Poster
     M Spencer, at al: The E=MC2 Project: Environment = Maintaining Cleanliness: A Multidisciplinary Approach To
     Establish a Routine Cleaning Schedule for Medical Equipment.



18
SSI risk can be addressed by
          controlling risk factors
           Precautions are already in place to control the risk of bacterial
             contamination throughout the peri-operative period

           However, additional controllable risk factors remain – wound
             closure provides an opportunity to address these risks


                  Controlled Risks                 Potentially Uncontrolled Risks
        Scrubbing in                          ☐ Bacterial colonization of the suture
        Gowning                               ☐ Contamination of the incisional site
        Skin antisepsis                         after the wound is closed
        Controlling OR environment            ☐ Entry of bacteria from the skin during
        Sterilizing instruments                 wound closure
        Using minimally invasive techniques   ☐ Bacterial infiltration due to dehiscence

19
Uncontrolled Risk Factor:
          Bacterial colonization of the suture

    Like all foreign bodies, sutures can be colonized by bacteria:
         Implants provide nidus for attachment of bacteria1
         Bacterial colonization can lead to biofilm formation1
         Biofilm formation increases the difficulty of treating an infection2

                                                                          On an implant, such as a
                                                                          suture, it takes only 100
                                                                          staphylococci per gram of
                                                                          tissue for an SSI to develop3
        Contamination           Colonization              Biofilm
                                                         Formation


  1.   Ward KH et al. J Med Microbiol. 1992;36: 406-413.
  2.   Kathju S et al Surg infect. 2009;10:457-461
20
  3.   Mangram AJ et al. Infect Control Hosp Epidemiol.1999;27:97-134..
Why Plus Suture?
OR Air Current Contamination
   In teaching hospitals:

   Surgeon leaves room
   Resident, Physician Assistant or Nurse
   Practitioner work on incision
   Circulating Nurse counts sponges and
   starts room breakdown
   Scrub Technician starts breaking down
   tables and preparing instruments for
   Central Processing
   Anesthesia move in and out of room
   Instrument representative might leave
   room and Visitors may leave room
Potential for Contamination of Sutures at
  End of Case



                                      Air settling plates in the operating room at
                                            the last hour of a total joint case




Suture with Staphylococcus colonies
Plus Antibacterial Sutures:
     Impact in a Real-World Setting
      Plus sutures not only kill bacteria on the suture, but also create an
       inhospitable environment around the suture

      NEBH studied the “zone of inhibition” around the suture
        A pure culture—0.5 MacFarland Broth—of S. aureus was
          prepared on a culture plate
         An antibacterial suture was aseptically cut, planted on the
          culture plate, and incubated for 24 hrs



                                                                         Traditional suture

                                                                       Antimicrobial suture
23              5 day zone of inhibition   10 day zone of inhibition
Plus Antibacterial Sutures:
         Impact in a Real-World Setting
  NEBH One Year Prospective Study of 3800 Total Joints
   and Antimicrobial Sutures
    In July 2005, implemented a full-year evaluation of
     antibacterial sutures usage in an orthopedic setting
    Changed product over July 4th holiday and did not tell
     all surgeons (only those involved with study)
  At the end of the year-long trial period:
    45% reduction in SSIs caused by Staph aureus and
     MRSA
    Infection rate dropped from                       0.5
                                                       0.4

     0.44% to 0.33% with three less infections 0.2     0.3
                                                                                                             Series1

                                                                                0.1
                                                                                 0
                                                                                      FY05     FY06
         NAON Poster Presentation - 2010
24
        Spencer M, et al: Reducing the Risk of Orthopedic Infections: The Role of Innovative Suture Technology
Articles Related To Antibacterial Sutures

 *Justinger, C, et al. Antibiotic coating of abdominal closure
  sutures and wound infection. Surgery 2009;145:330-4. (*RCT)
 Rothenburger S, et al. In vitro antimicrobial evaluation of Coated
  VICRYL* Plus Antibacterial Suture (coated polyglactin 910 with
  triclosan) using zone of inhibition assays. Surg Infect 2002;3 Suppl 1:S79-
  87
 Ford HR, et al. Intraoperative handling and wound healing: controlled
  clinical trial comparing coated VICRYL plus antibacterial suture (coated
  polyglactin 910 suture with triclosan) with coated VICRYL suture (coated
  polyglactin 910 suture). Surgical Infections. 6(3):313-21, 2005.
 Edmiston CE, et al. Bacterial adherence to surgical sutures: can
  antibacterial-coated sutures reduce the risk of microbial contamination?
  Journal of the American College of Surgeons. 203(4):481-9, 2006 Oct
Innovative wound closure technologies
          can address risk factors for SSIs
           Topical Skin Adhesive provides a microbial barrier during the
             critical wound healing period

                   SSI Risk Factor                             Innovative Technology
      Bacterial colonization of the suture              Antibacterial Sutures
      Contamination of the incisional site after the    Chlorhexidine/alcohol skin prep
       wound is closed                                   Prevention of Dehiscence and
      Entry of bacteria from the skin during             Exogenous Contamination with
       wound closure                                      Topical Skin Adhesive or
      Bacterial infiltration due to dehiscence           Antimicrobial Dressings




26
Antisepsis with Chlorhexidine
 2% CHG/70% alcohol skin preparation
  (tinted orange)
    Has a lasting effect on the skin
        ~ 2 days postop
    Iodophors are fast kill but no long term
      effect
    CHG dry time is 3 minutes (to prevent
      fires)

• Evidence that chlorhexidine/alcohol achieves
  better skin antisepsis than iodophor

    Darouiche et al NEJM 2010
    Ostrander et al JBJS Am 2005
    Saltzman et al JBJS Am 2009

                                                  27
Post-op Skin Issues in Orthopedics




   Anterior fusion with tape burns
                                                  Contaminated steri-strips




Posterior fusion with contaminated steri-strips   Staples increase infection rate
Associated Wound Infection or Separation After
Cesarean Delivery: Sutures vs Staples
 Prospective, randomized study of 435 c-section patients1
      197 patients: staples
      219 patients: 4-0 MONOCRYL™ (poliglecaprone 25) Suture on PS2 needle
          – Wound separation rate: 17% (staples) vs. 5 % (sutures)
          – Wound complication rate: 22% (staples) vs. 9% (sutures)
          – Staple closure was a significant independent risk factor for wound
              separation after adjustment for all other factors (GDM, BMI >30, incision
              type, etc)
 Meta-analysis of 6 studies with a total of 1487 c-section patients2
      803 patients: staples
      684 patients: subcuticular suture closure
          – Staple closure was associated with a two-fold increase in risk of wound
              infection or separation
 1. Basha et al. Am J Obstet Gynecol. 2010;203:285.e1.
 2. Tuuli et al. Obset Gynecol. 2011;117:682.
The risk for infection after joint surgery is higher with staples vs traditional
stitches, according to the results of a meta-analysis reported in the March
16 2010 issue of the BMJ.

 In 6 publications reporting on a total of 683 wounds, 332 patients underwent
   wound closure with sutures, and 351 underwent closure with staples.
 Compared with suture closure, staple closure was associated with more
   than triple the risk for the development of a superficial wound
   infection after orthopaedic surgery (RR, 3.83; 95% CI, 1.38 – 10.68; P =
   .01).
 When hip surgery was analyzed as a separate subgroup, the risk for the
   development of a wound infection was 4 times greater with use of
   staples vs use of sutures (RR, 4.79, 95% CI, 1.24 – 18.47; P = .02). Suture
   closure and staple closure did not differ significantly in development of
   inflammation, discharge, dehiscence, necrosis, or allergic reaction.
 “The Medical Journal of Australia” has recently updated its guidelines for skin
   closure in the treatment of hip fractures, and they state that superficial wound
   complication rates are higher for wounds closed with metallic staples than for
   wounds closed with subcuticular vicryl.
Obesity and Surgical Incision

      Incision collects fluid – serum,
       blood - growth medium for
       organisms
      Spine fusions -incisions close to the
       buttocks or neck
      Heavy perspiration common
      Body fluid contamination from
       bedpans/commodes
      Friction and sliding - skin tears and
       blisters
      Itchy skin - due to pain medications
       - skin breakdown


31
Topical Skin Adhesive: A Proven Microbial
           Barrier
      Provides a flexible, protective microbial barrier that moves with the patient,
           preventing breakage and acting like a temporary “skin”1,2
      Adhesive demonstrates inhibition of gram-positive bacteria (MRSA and MRSE) and
           gram-negative bacteria (E coli) in vitro2-4
      Provides greater than 99% protection for 72 hours against organisms commonly
           responsible for SSIs2,3:
            S. epidermidis
            E. coli
            S. aureus
            Pseudomonas aeruginosa
            Enterococcus faecium
                                                                                      No fractures,
      1.     Quinn et al. JAMA. 1997;277:1527-1530                                    wound failure
      2.     Bhende et al. Surg Infect (Larchmt). 2002;3:251-257.                     or dehiscence
      3.     Narang et al. J Cutan Med Surg. 2003;7:13.
      4.     World Health Organization. WHO Guidelines for Safe Surgery 2009. 2009.

32
Topical Skin Adhesive: Benefits Beyond Risk
 Reduction
 For Hospital Staff
   No time spent removing staples or sutures
   Reduced hospitalization costs
   Reduces number of suture set ups
   Simplifies post-op wound checks
   Reduces number of wound dressings

 For Patients
   7 days of wound healing strength in
    less than 95 seconds of application
   Shower immediately
   Outstanding cosmesis
   Reduced follow-up
   Less pain and anxiety


33
Incisional Adhesive on Total Knee Incision
Clinical Use of Incisionial Adhesive
            Hip: Sealed with adhesive
            covered with gauze and
            transparent dressing for
            incision protection

            Knee: Sealed with incisional
            adhesive, covered with Telfa
            and a transparent dressing     Healed incision
            for incision protection
Incisional Adhesive and Total
Shoulder Replacements
                                                   Total Shoulder Rates


                               2.5

                                2

                               1.5

                                1

                               0.5

                                0
                                     2003   2004   2005   2006   2007   2008   2009   2010



•   Propionibacterium acnes related total shoulder infections (TSR)
•   Eliminated the use of staples for TSR
•   Instituted the use of incisional adhesive
•   Covered dressing until day of discharge for protection
Selected Publications: DERMABOND® Topical
           Skin Adhesive in Orthopedic Surgery

    Procedure                        Reference               No. of Patients    Key Findings

                                                                                • Patients followed for >7 months
    Primary hip   arthroplasty1      Khurana et al. 2008             93         • No infections
                                                                                • 1 wound dehiscence


                                                                                • Patients followed for >5 months
    Lumbar and cervical spine                                        200
                                     Hall and Bailes. 2005                      • Only 1 documented SSI
    procedures2                                                 Retrospective
                                                                                • High patient satisfaction


                                                                                • Surgeon preference to reduce urinary
    Total hip arthroplasty for       Kregor et al. 2008                           and fecal contamination of wound
                                                                Retrospective
    femoral neck fracture3                                                        and allow patients to shower
                                                                                  immediately




1. Khurana et al. Acta Orthop Belg. 2008;74:349.
2. Hall and Bailes. Neurosurgery. 2005;56(suppl 1):147.
3. Kregor et al. Techniques Ortho. 2008;23:312.
DERMABOND ADVANCED™ Topical Skin Adhesive

                 A protective barrier that adds strength and reduces bacteria

  • Has been shown in ex vivo studies to have superior tensile strength versus other octyl
       and butyl based products
  • Creates a microbial barrier against organisms commonly responsible for SSIs *




  Innovative




    *Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, Enterococcus faecium and Pseudomonas aeruginosa
Data on File. Ethicon, Inc.
Comparison of TSA Components Among Currently
     Available Agents
            DERMABOND
            ADVANCED™
             Topical Skin            derma+flex® QS™           Histoacryl®
 Components   Adhesive    SurgiSeal™    (octylseal™) INDERMIL® (Repara)             LiquiBand®   Skinstitch®

Octyl
adhesive



Plasticizers                                           ?
Inert storage
vial,
stabilizer, and
no
refrigeration

Initiator and
heat-
dissipating
agent

High-
viscosity
formulation

The third-party trademarks used herein are trademarks of their respective owners.
Data on file: Ethicon Inc.
Evidence-Based Performance
    The largest randomized clinical trial database of any TSA
          8x the number of patients vs the leading competitor


                                                             Total Number     Total Number of
                          Product                              of RCTs        Patients Treated
                          DERMABOND®
                                                                40                  4075
                          Topical Skin Adhesive
                          Histoacryl®                            6                  534

                          INDERMIL®                              2                  150

                          LiquiBand®                             1                   78
                          SurgiSeal®                             0                    0
                          derma+flex® QS™
                                                                 0                    0
                          (octylseal™)

No RCTs identified for any other competitors.
RCTs only; reasons for exclusion were language of publication other than German or English, nonhuman studies, case series or
case reports, and inappropriate indication.

The third-party trademarks used herein are trademarks of their respective owners.
RCT = randomized controlled trials.
Data on file: Ethicon Inc, Literature Search 2/2011 PubMed
New, innovative, minimally invasive
     DERMABOND™ PRINEO™ Skin Closure System

      A unique combination of
       2 components
       • A 2-octyl cyanoacrylate topical skin
         adhesive for proven strength and
         microbial protection1,2
          – Sets in approximately 60 seconds
            when applied to mesh
          – 2-hour working time3

       • A flexible, self-adhesive polyester mesh
         for superior approximation and healing1,3
          – Contains initiator that accelerates
            polymerization of liquid adhesive
          – Each dispenser contains 60 cm of tape
      1. DERMABOND™ PRINEO™ IFU. PM72449C. STATUS 6/2010.
41    2. Shapiro AJ et al. Am Surg. 2001;67(11): 1113‐1115.
      3. Data on file. Ethicon, Inc.
Minimally invasive closure that distributes tension
     away from the wound




         Traditional closure     DERMABOND™ PRINEO™ Skin Closure
                                            System



       Gently and evenly disperses tension across the entire area
        of the incision, without penetrating the skin


42
DERMABOND™ PRINEO™ removal




Patient is shown 2 weeks after circumferential body lift and immediately
                             after removal of
             DERMABOND™ PRINEO™ Skin Closure System.
Areas for Cost Savings
Surgical Incise Drapes

 Iodophor- impregnated incise
  barrier drape
   No data to support these
    drapes reduce SSI – although
    do reduce bacteria on skin
   Surgeon preference based on
    adhesion to skin and drapes
   Consider using non-
    impregnated drapes and using
    cost savings for other innovative
    technologies
                                        45
Use of plastic adhesive drapes during surgery
for preventing surgical site infection
Objective:
 Compared the effect of adhesive drapes used during surgery on surgical site
  infection, cost, mortality and morbidity
 Five studies involving 3,082 participants comparing adhesive drapes with no
  drape
 Two studies involving 1,113 participants comparing iodine-impregnated
  adhesive drapes with no drape
Conclusion:
 A significantly higher proportion of patients in adhesive drape group
  developed a surgical site infection when compared with no drape
 Iodine-impregnated adhesive drapes had no effect on the surgical site
  infection rate

 Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006353
Bacitracin/Polymixin Irrigation
 Feb 2007 - stopped routine use of Bacitracin/Polymixin Irrigation
 Cost: > $110,000/year reduced to $10,000
 Limited use for revisions, allografts and infected cases (irrigation and
  debridements)
 New irrigant available – FDA approved for mucous membranes with
  0.05% CHG - Irrisept

Fletcher N, et al: Prevention of perioperative infections. J Bone
  Joint Surg Am. 2007;89:1605-1618


                                                                             47
IRRISEPT
  Finally, an alternative to saline and antimicrobial irrigation
  The first and only FDA-cleared cleansing and debridement system, containing
  0.05% Chlorhexidine Gluconate (CHG) in Water for Irrigation



                               IrriSept O.R. (sterile packaging)




Irrigation Applicators:
Custom designed
applicators facilitate
cleansing for a variety of
applications

                             SplatterGuard®      LT SplatterGuard®     IrriProbe®
        48
Review: Bundled Approach to Eliminating SSIs
1.    Pre-screen inpatient surgeries for MRSA and Staph aureus (MSSA) using PCR
      rapid molecular technology
2.    Decolonization protocol for MRSA/MSSA positive patients (eg mupirocin 2%
      ointment 2 x day, daily CHG wash x 5 days)
3.    Preoperative shower with CHG (eg Hibiclens) or CHG washcloths (eg Sage) night
      before/morning of surgery
4.    Assure OR standards are being met (traffic control, surgical attire, surgical hand
      scrub, sterilized instruments, room turnover and terminal cleaning, precautions in
      OR)
5.    Assure surgical prophylaxis is delivered for maximum tissue concentrations
6.    Surgical skin prep with CHG/alcohol prep
7.    Irrigation with CHG if necessary (eg Irrisept)
8.    Antibacterial sutures (eg Ethicon)
9.    Incisional Adhesive (octyl cyanoacrylate) (eg Dermabond and Prineo)
10.   Post-op incision care instructions
11.   Data driven, analysis and calculation of rates, communication/feedback
Reducing Risk Factors for SSIs:
     Tools for success
      Institutional support
         Senior leadership and “C Suite” involvement
         “lead the effort” from top down
      Clear goals
         Structured program with clearly defined goal of
         zero tolerance for HAIs
        Theoretical foundation to IP Program: Social
         Learning Theory (Role Modeling, Self Efficacy,
         Positive Deviance)
      Communication – effective and consistent
      Ongoing and creative education
      Financial support to Infection Prevention program

50
Thank You

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Establishing a culture of safety april 2012

  • 1. Establishing a Culture of Safety: Working Toward Zero Orthopedic SSIs Maureen Spencer, RN, M.Ed, CIC Infection Preventionist Consultant Boston, MA Email: maureen_spncr@yahoo.com www.workingtowardzero.com www.creativehandhygiene.com
  • 2. Example of Working Toward Zero Team Members  The teams:  Surgical Site Infections: Director Surgical Services, OR Manager, SPD Director, Infection Control Manager, Two Surgeons, VP Patient Care Services, Director of Nursing, Nursing Manager, Clinical Educator, Microbiology Lab Director  Ventilator Associated Pneumonia: ICU Hospitalist, ICU Nurse Manager, ICU Nurse, Director of Anesthesia, ICU Clinical Educator, Respiratory Therapy, Infection Control Manager, Micro Lab  Central Line Assoc Bloodstream Infections: Surgeon who inserted most central lines, ICU Manager, Director of Anesthesia, ICU Clinical Educator, ICU Nurse, Infection Control Manager  Catheter Assoc UTI: Clinical Educator, Infection Control Manager, Chief Urology, Lab Director  MRSA Elimination: Infection Control Manager, Pre-admission testing, OR Director, Microbiology Lab Director, Two Surgeons, Director of Nursing, Patient Access Director,  Information Technology, ID physician  C.difficile: Chiefs of Surgery and Gastroenterology, ICU Nurse Manager, Micro Lab Director, Infection Control Manager 2
  • 3. Post-op: Irrigation? Incisional Patient adhesive should education is Consider using be the number extremely Intraoperative: saline or new one consideration important since CHG/alcohol CHG (0.05%) for wound many patients skin prep, irrigant and closure – are discharged antibacterial eliminate prevents early in the Pre-op: sutures, expensive and dehiscence and post-op period incisional toxic exogenous and have Screen for MRSA bacitracin/polymi and Staph aureus adhesive contamination to incisions that are xin or antibiotic wound in the exudative CHG pre-op irrigant shower or cleanse If not used state of wound with impregnated consider covering healing cloths incision for length Assure OR meets of hospitalization AORN standards of practice
  • 4. MRSA and Staph aureus Elimination Program Before Patients Enter the Hospital for Surgery Prescreening Process Topical Decolonization Protocol Vancomycin for MRSA 1. Kim D, Spencer M, Davidson S, et al. J Bone Joint Surg 2010;92:1820-6 2. Spencer M, Kim D, et al: AAOS, 2010 4
  • 5. Provided Evidence: February 2006 Anonymous Nares Cultures To Prove to Administration Patients Are Colonized With Staph aureus and MRSA N = 133 patients anonymously surveyed and cultured in OR after anesthetized Purpose: to determine pre-op MRSA and Staph aureus colonization rates for administration Results: 38 – Staph aureus (29%) *5 - MRSA ( 4%) *all undiagnosed, no precautions used in OR, PACU, postop nursing unit *MRSA cases received Cefazolin for surgical 5 prophylaxis – THE WRONG ANTIBIOTIC!
  • 6. Implemented Decolonization Protocol • 5-day application of intranasal 2% mupirocin - applied twice daily - for MRSA and Staph aureus positive patients • Prescription called in by Nurse Practitioner in prescreening unit • Daily body wash with chlorhexidine (purchased by patient) • MRSA Patients – Unique sticker system to notify Pre-surgery Unit of Vancomycin surgical prophylaxis 6
  • 7. 7
  • 8. Pre-op MRSA and S. aureus Decolonization  Results:  Timeframe: July 17, 2006 through September 2010  Infection rate: 20,065 patient screened 5,988 (23%) positive for Staph aureus 1,027 ( 4%) positive for MRSA  Effectiveness: Repeat nasal screens on MRSA patients revealed 77% eradication 8
  • 9. Pre-op MRSA and S. aureus Decolonization  Results: % MRSA and S. aureus SSI Inpatient # of Surgical Time Period %MRSA/MSSA Surgeries Infections FY06 10/01/05-07/16/06* 5,293* 24* 0.45%* *Historical Controls FY07 07/17/06-09/30/07 7,019 6 0.08% FY08 10/01/07-09/30/08 6,323 7 0.11% FY09 10/01/08-09/30/09 6,364 11 0.17% FY10 10/01/10-09/30/10 6,437 6 0.09% 9
  • 10. Pre-op MRSA Decolonization  Results: % MRSA SSI in Screened Patients Inpatient # MRSA #Infect/#MRSA Time Period MRSA% Surgeries SSIs + FY06 10/01/05-07/16/06 5,293 10 (NA) 0.19% NA FY07 07/17/06-09/30/07 7,019 3 (3+) 0.04% 3/309 (0.97%) FY08 10/01/07-09/30/08 6,245 4 (2+) 0.06% 2/242 (0.83%) FY09 10/01/08-09/30/09 6,336 6* (2+) 0.09% 2/234 (0.85%) FY10 10/01/10-09/30/10 6,437 1 (1+) 0.01% 1/266 (0.37%) * isolates have been sent for pulse field gel electrophoresis 10 5 of the 6 isolates were available for PFGE and were not related genetically
  • 11. Pre-op Staph aureus Decolonization  Results: % S. aureus (MSSA) SSI in Screened Patients Inpatient # MSSA #Infect/#MSSA Time Period MSSA% Surgeries SSIs + FY06 10/01/05-07/16/06 5,293 14 (NA) 0.26% NA FY07 07/17/06-09/30/07 7,019 3 (3+) 0.04% 3/1588 (0.19%) FY08 10/01/07-09/30/08 6,245 3 (1+) 0.05% 1/ 1422 (0.07%) FY09 10/01/08-09/30/09 6,336 5 (1+) 0.08% 3/1403 (0.21%) FY10 10/01/10-09/30/10 6,437 6 (1+) 0.09% 1/1450 (0.06%) 11
  • 12. OR Risk Factors: Contamination from OR Staff • Reviewed orderlies and room turnover procedures • Improved traffic control – new signage and monitoring system keep room doors closed and minimize traffic • Eliminate surgical caps – do not cover hair! • Cloth cap use – if worn, must be covered in OR room with disposable cap - hair coverage monitored – Hair harbors organisms – Staff sweat in cloth caps – How often do they get washed? Hospital laundered – Where are they stored? – Would you eat a meal with hair in it? – Why allow hair to potentially fall into surgical incisions? 12
  • 13. OR Risk Factors: Cleaning/Sterilization of Instruments • Inspection of Orthopedic Instruments – Lumens, grooves, sorting, hand cleaning, disassembly required – massive kits – Many instruments cannot be disassembled • Instituted better pre-soaking and rinsing of tissue and blood from the instruments in the operating room before decontamination • There was a recent outbreak investigated by CDC of shoulder infections - found shavers and cannulas with biofilm and tissue observed inside instruments with small camera 13
  • 14. Pathogens survive on surfaces Organism Survival period Clostridium difficile 35- >200 days.2,7,8 Methicillin resistant Staphylococcus aureus (MRSA) 14- >300 days.1,5,10 Vancomycin-resistant enterococcus (VRE) 58- >200 days.2,3,4 Escherichia coli >150- 480 days.7,9 Acinetobacter 150- >300 days.7,11 Klebsiella >10- 900 days.6,7 Salmonella typhimurium 10 days- 4.2 years.7 Mycobacterium tuberculosis 120 days.7 Candida albicans 120 days.7 Most viruses from the respiratory tract (eg: corona, Few days.7 coxsackie, influenza, SARS, rhino virus) Viruses from the gastrointestinal tract (eg: astrovirus, HAV, 60- 90 days.7 polio- or rota virus) Blood-borne viruses (eg: HBV or HIV) >7 days.5 1. Beard-Pegler et al. 1988.. J Med Microbiol. 26:251-5. 7. Kramer et al. 2006. BMC Infect Dis. 6:130. 2. BIOQUELL trials, unpublished data. 8. Otter and French. 2009. J Clin Microbiol. 47:205-7. 3. Bonilla et al. 1996. Infect Cont Hosp Epidemiol. 17:770-2 9. Smith et al. 1996. J Med. 27: 293-302. 4. Boyce. 2007. J Hosp Infect. 65:50-4. 10. Wagenvoort et al. 2000. J Hosp Infect. 45:231-4. 5. Duckworth and Jordens. 1990. J Med Microbiol. 32:195-200. 11. Wagenvoort and Joosten. 2002. J Hosp Infect. 52:226-7. 6. French et al. 2004. ICAAC.
  • 15. Why Better Environmental Cleaning? Prior room occupancy increases risk Study Healthcare associated pathogen Likelihood of patient acquiring HAI based on prior room occupancy (comparing a previously ‘positive’ room with a previously ‘negative’ room) Martinez 20031 VRE – cultured within room 2.6x VRE – prior room occupant 1.6x Huang 20062 MRSA – prior room occupant 1.3x VRE – cultured within room 1.9x VRE – prior room occupant 2.2x Drees 20083 VRE – prior room occupant in previous two 2.0x weeks Shaughnessy 20084 C. difficile – prior room occupant 2.4x A. baumannii – prior room occupant 3.8x Nseir 20105 P. aeruginosa – prior room occupant 2.1x 1. Martinez et al. Arch Intern Med 2003; 163: 1905-12. 2. Huang et al. Arch Intern Med 2006; 166: 1945-51. 3. Drees et al. Clin Infect Dis 2008; 46: 678-85. 4. Shaughnessy. ICAAC/IDSA 2008. Abstract K-4194. 5. Nseir et al. Clin Microbiol Infect 2010 (in press).
  • 16. Rates of Surface Contamination (in hospitals) with MSRA, VRE, and C. Difficile Blood Pressure Cuff: Windowsill: VRE 14% C. Difficile 33% Commode: Overbed Table: C. Difficile 41% MRSA 40% VRE 20% Patient Gowns: MRSA 51% Bedrail: MRSA 29% Floors: VRE 28% MRSA 55% C. Difficile 19% C. Difficile 48% Bedsheets: MRSA 53% Did you know that every time you get a new roommate, there is an VRE 40% increase of 3-10% that you will acquire an HAI. Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51 Boyce J.M. et al.: Environmental contamination due to methicillin-resistant Staphylococcus aureus: Possible infection control implications. Infect Control Hosp Epidemiol 18:622-627, Sep. 1997. Slaughter S., et al.: A comparison of the effect of universal use of gloves and gowns with that of glove use alone on acquisition of vancomycin-resistant enterococci in a medical intensive care unit. Ann Intern Med 125: 448-456, Sep 15, 1996. Samore M.H., et al.: Clinical and molecular epidemiology of sporadic and clustered cases of nosocomial Clostridium difficile diarrhea. Am J Med 100:32-40, Jan. 1996.
  • 17. Environmental Disinfection – Joint Commission and CMS Focus on Surveys  Developed cleaning schedules for Patient Care Services – what equipment, how cleaned/disinfected, how often, by who, contact times for disinfectants?  Eliminate dirty buckets of water and string mops  institute micro fiber cloths and mops  Assure staff know proper cleaning technique:  left to right, high to low, clean to dirty with competencies  Daily check sheet for terminal cleaning of OR at night and for all precaution cases 17
  • 18. Decontamination of Portable Equipment with Contracted Services  Ultrasonic scrub  Movable carts  Tables  Poles  Small equipment  1500 pieces cleaned  OR, radiology, nursing  Cost: ~$20,000 / year APIC 2005 Poster M Spencer, at al: The E=MC2 Project: Environment = Maintaining Cleanliness: A Multidisciplinary Approach To Establish a Routine Cleaning Schedule for Medical Equipment. 18
  • 19. SSI risk can be addressed by controlling risk factors  Precautions are already in place to control the risk of bacterial contamination throughout the peri-operative period  However, additional controllable risk factors remain – wound closure provides an opportunity to address these risks Controlled Risks Potentially Uncontrolled Risks  Scrubbing in ☐ Bacterial colonization of the suture  Gowning ☐ Contamination of the incisional site  Skin antisepsis after the wound is closed  Controlling OR environment ☐ Entry of bacteria from the skin during  Sterilizing instruments wound closure  Using minimally invasive techniques ☐ Bacterial infiltration due to dehiscence 19
  • 20. Uncontrolled Risk Factor: Bacterial colonization of the suture  Like all foreign bodies, sutures can be colonized by bacteria:  Implants provide nidus for attachment of bacteria1  Bacterial colonization can lead to biofilm formation1  Biofilm formation increases the difficulty of treating an infection2 On an implant, such as a suture, it takes only 100 staphylococci per gram of tissue for an SSI to develop3 Contamination Colonization Biofilm Formation 1. Ward KH et al. J Med Microbiol. 1992;36: 406-413. 2. Kathju S et al Surg infect. 2009;10:457-461 20 3. Mangram AJ et al. Infect Control Hosp Epidemiol.1999;27:97-134..
  • 21. Why Plus Suture? OR Air Current Contamination In teaching hospitals: Surgeon leaves room Resident, Physician Assistant or Nurse Practitioner work on incision Circulating Nurse counts sponges and starts room breakdown Scrub Technician starts breaking down tables and preparing instruments for Central Processing Anesthesia move in and out of room Instrument representative might leave room and Visitors may leave room
  • 22. Potential for Contamination of Sutures at End of Case Air settling plates in the operating room at the last hour of a total joint case Suture with Staphylococcus colonies
  • 23. Plus Antibacterial Sutures: Impact in a Real-World Setting  Plus sutures not only kill bacteria on the suture, but also create an inhospitable environment around the suture  NEBH studied the “zone of inhibition” around the suture  A pure culture—0.5 MacFarland Broth—of S. aureus was prepared on a culture plate  An antibacterial suture was aseptically cut, planted on the culture plate, and incubated for 24 hrs Traditional suture Antimicrobial suture 23 5 day zone of inhibition 10 day zone of inhibition
  • 24. Plus Antibacterial Sutures: Impact in a Real-World Setting  NEBH One Year Prospective Study of 3800 Total Joints and Antimicrobial Sutures  In July 2005, implemented a full-year evaluation of antibacterial sutures usage in an orthopedic setting  Changed product over July 4th holiday and did not tell all surgeons (only those involved with study)  At the end of the year-long trial period:  45% reduction in SSIs caused by Staph aureus and MRSA  Infection rate dropped from 0.5 0.4 0.44% to 0.33% with three less infections 0.2 0.3 Series1 0.1 0 FY05 FY06 NAON Poster Presentation - 2010 24  Spencer M, et al: Reducing the Risk of Orthopedic Infections: The Role of Innovative Suture Technology
  • 25. Articles Related To Antibacterial Sutures  *Justinger, C, et al. Antibiotic coating of abdominal closure sutures and wound infection. Surgery 2009;145:330-4. (*RCT)  Rothenburger S, et al. In vitro antimicrobial evaluation of Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect 2002;3 Suppl 1:S79- 87  Ford HR, et al. Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture with triclosan) with coated VICRYL suture (coated polyglactin 910 suture). Surgical Infections. 6(3):313-21, 2005.  Edmiston CE, et al. Bacterial adherence to surgical sutures: can antibacterial-coated sutures reduce the risk of microbial contamination? Journal of the American College of Surgeons. 203(4):481-9, 2006 Oct
  • 26. Innovative wound closure technologies can address risk factors for SSIs  Topical Skin Adhesive provides a microbial barrier during the critical wound healing period SSI Risk Factor Innovative Technology  Bacterial colonization of the suture  Antibacterial Sutures  Contamination of the incisional site after the  Chlorhexidine/alcohol skin prep wound is closed  Prevention of Dehiscence and  Entry of bacteria from the skin during Exogenous Contamination with wound closure Topical Skin Adhesive or  Bacterial infiltration due to dehiscence Antimicrobial Dressings 26
  • 27. Antisepsis with Chlorhexidine  2% CHG/70% alcohol skin preparation (tinted orange)  Has a lasting effect on the skin  ~ 2 days postop  Iodophors are fast kill but no long term effect  CHG dry time is 3 minutes (to prevent fires) • Evidence that chlorhexidine/alcohol achieves better skin antisepsis than iodophor Darouiche et al NEJM 2010 Ostrander et al JBJS Am 2005 Saltzman et al JBJS Am 2009 27
  • 28. Post-op Skin Issues in Orthopedics Anterior fusion with tape burns Contaminated steri-strips Posterior fusion with contaminated steri-strips Staples increase infection rate
  • 29. Associated Wound Infection or Separation After Cesarean Delivery: Sutures vs Staples  Prospective, randomized study of 435 c-section patients1  197 patients: staples  219 patients: 4-0 MONOCRYL™ (poliglecaprone 25) Suture on PS2 needle – Wound separation rate: 17% (staples) vs. 5 % (sutures) – Wound complication rate: 22% (staples) vs. 9% (sutures) – Staple closure was a significant independent risk factor for wound separation after adjustment for all other factors (GDM, BMI >30, incision type, etc)  Meta-analysis of 6 studies with a total of 1487 c-section patients2  803 patients: staples  684 patients: subcuticular suture closure – Staple closure was associated with a two-fold increase in risk of wound infection or separation 1. Basha et al. Am J Obstet Gynecol. 2010;203:285.e1. 2. Tuuli et al. Obset Gynecol. 2011;117:682.
  • 30. The risk for infection after joint surgery is higher with staples vs traditional stitches, according to the results of a meta-analysis reported in the March 16 2010 issue of the BMJ.  In 6 publications reporting on a total of 683 wounds, 332 patients underwent wound closure with sutures, and 351 underwent closure with staples.  Compared with suture closure, staple closure was associated with more than triple the risk for the development of a superficial wound infection after orthopaedic surgery (RR, 3.83; 95% CI, 1.38 – 10.68; P = .01).  When hip surgery was analyzed as a separate subgroup, the risk for the development of a wound infection was 4 times greater with use of staples vs use of sutures (RR, 4.79, 95% CI, 1.24 – 18.47; P = .02). Suture closure and staple closure did not differ significantly in development of inflammation, discharge, dehiscence, necrosis, or allergic reaction.  “The Medical Journal of Australia” has recently updated its guidelines for skin closure in the treatment of hip fractures, and they state that superficial wound complication rates are higher for wounds closed with metallic staples than for wounds closed with subcuticular vicryl.
  • 31. Obesity and Surgical Incision  Incision collects fluid – serum, blood - growth medium for organisms  Spine fusions -incisions close to the buttocks or neck  Heavy perspiration common  Body fluid contamination from bedpans/commodes  Friction and sliding - skin tears and blisters  Itchy skin - due to pain medications - skin breakdown 31
  • 32. Topical Skin Adhesive: A Proven Microbial Barrier  Provides a flexible, protective microbial barrier that moves with the patient, preventing breakage and acting like a temporary “skin”1,2  Adhesive demonstrates inhibition of gram-positive bacteria (MRSA and MRSE) and gram-negative bacteria (E coli) in vitro2-4  Provides greater than 99% protection for 72 hours against organisms commonly responsible for SSIs2,3:  S. epidermidis  E. coli  S. aureus  Pseudomonas aeruginosa  Enterococcus faecium No fractures, 1. Quinn et al. JAMA. 1997;277:1527-1530 wound failure 2. Bhende et al. Surg Infect (Larchmt). 2002;3:251-257. or dehiscence 3. Narang et al. J Cutan Med Surg. 2003;7:13. 4. World Health Organization. WHO Guidelines for Safe Surgery 2009. 2009. 32
  • 33. Topical Skin Adhesive: Benefits Beyond Risk Reduction  For Hospital Staff  No time spent removing staples or sutures  Reduced hospitalization costs  Reduces number of suture set ups  Simplifies post-op wound checks  Reduces number of wound dressings  For Patients  7 days of wound healing strength in less than 95 seconds of application  Shower immediately  Outstanding cosmesis  Reduced follow-up  Less pain and anxiety 33
  • 34. Incisional Adhesive on Total Knee Incision
  • 35. Clinical Use of Incisionial Adhesive Hip: Sealed with adhesive covered with gauze and transparent dressing for incision protection Knee: Sealed with incisional adhesive, covered with Telfa and a transparent dressing Healed incision for incision protection
  • 36. Incisional Adhesive and Total Shoulder Replacements Total Shoulder Rates 2.5 2 1.5 1 0.5 0 2003 2004 2005 2006 2007 2008 2009 2010 • Propionibacterium acnes related total shoulder infections (TSR) • Eliminated the use of staples for TSR • Instituted the use of incisional adhesive • Covered dressing until day of discharge for protection
  • 37. Selected Publications: DERMABOND® Topical Skin Adhesive in Orthopedic Surgery Procedure Reference No. of Patients Key Findings • Patients followed for >7 months Primary hip arthroplasty1 Khurana et al. 2008 93 • No infections • 1 wound dehiscence • Patients followed for >5 months Lumbar and cervical spine 200 Hall and Bailes. 2005 • Only 1 documented SSI procedures2 Retrospective • High patient satisfaction • Surgeon preference to reduce urinary Total hip arthroplasty for Kregor et al. 2008 and fecal contamination of wound Retrospective femoral neck fracture3 and allow patients to shower immediately 1. Khurana et al. Acta Orthop Belg. 2008;74:349. 2. Hall and Bailes. Neurosurgery. 2005;56(suppl 1):147. 3. Kregor et al. Techniques Ortho. 2008;23:312.
  • 38. DERMABOND ADVANCED™ Topical Skin Adhesive A protective barrier that adds strength and reduces bacteria • Has been shown in ex vivo studies to have superior tensile strength versus other octyl and butyl based products • Creates a microbial barrier against organisms commonly responsible for SSIs * Innovative *Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, Enterococcus faecium and Pseudomonas aeruginosa Data on File. Ethicon, Inc.
  • 39. Comparison of TSA Components Among Currently Available Agents DERMABOND ADVANCED™ Topical Skin derma+flex® QS™ Histoacryl® Components Adhesive SurgiSeal™ (octylseal™) INDERMIL® (Repara) LiquiBand® Skinstitch® Octyl adhesive Plasticizers ? Inert storage vial, stabilizer, and no refrigeration Initiator and heat- dissipating agent High- viscosity formulation The third-party trademarks used herein are trademarks of their respective owners. Data on file: Ethicon Inc.
  • 40. Evidence-Based Performance  The largest randomized clinical trial database of any TSA  8x the number of patients vs the leading competitor Total Number Total Number of Product of RCTs Patients Treated DERMABOND® 40 4075 Topical Skin Adhesive Histoacryl® 6 534 INDERMIL® 2 150 LiquiBand® 1 78 SurgiSeal® 0 0 derma+flex® QS™ 0 0 (octylseal™) No RCTs identified for any other competitors. RCTs only; reasons for exclusion were language of publication other than German or English, nonhuman studies, case series or case reports, and inappropriate indication. The third-party trademarks used herein are trademarks of their respective owners. RCT = randomized controlled trials. Data on file: Ethicon Inc, Literature Search 2/2011 PubMed
  • 41. New, innovative, minimally invasive DERMABOND™ PRINEO™ Skin Closure System  A unique combination of 2 components • A 2-octyl cyanoacrylate topical skin adhesive for proven strength and microbial protection1,2 – Sets in approximately 60 seconds when applied to mesh – 2-hour working time3 • A flexible, self-adhesive polyester mesh for superior approximation and healing1,3 – Contains initiator that accelerates polymerization of liquid adhesive – Each dispenser contains 60 cm of tape 1. DERMABOND™ PRINEO™ IFU. PM72449C. STATUS 6/2010. 41 2. Shapiro AJ et al. Am Surg. 2001;67(11): 1113‐1115. 3. Data on file. Ethicon, Inc.
  • 42. Minimally invasive closure that distributes tension away from the wound Traditional closure DERMABOND™ PRINEO™ Skin Closure System  Gently and evenly disperses tension across the entire area of the incision, without penetrating the skin 42
  • 43. DERMABOND™ PRINEO™ removal Patient is shown 2 weeks after circumferential body lift and immediately after removal of DERMABOND™ PRINEO™ Skin Closure System.
  • 44. Areas for Cost Savings
  • 45. Surgical Incise Drapes  Iodophor- impregnated incise barrier drape  No data to support these drapes reduce SSI – although do reduce bacteria on skin  Surgeon preference based on adhesion to skin and drapes  Consider using non- impregnated drapes and using cost savings for other innovative technologies 45
  • 46. Use of plastic adhesive drapes during surgery for preventing surgical site infection Objective:  Compared the effect of adhesive drapes used during surgery on surgical site infection, cost, mortality and morbidity  Five studies involving 3,082 participants comparing adhesive drapes with no drape  Two studies involving 1,113 participants comparing iodine-impregnated adhesive drapes with no drape Conclusion:  A significantly higher proportion of patients in adhesive drape group developed a surgical site infection when compared with no drape  Iodine-impregnated adhesive drapes had no effect on the surgical site infection rate  Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006353
  • 47. Bacitracin/Polymixin Irrigation  Feb 2007 - stopped routine use of Bacitracin/Polymixin Irrigation  Cost: > $110,000/year reduced to $10,000  Limited use for revisions, allografts and infected cases (irrigation and debridements)  New irrigant available – FDA approved for mucous membranes with 0.05% CHG - Irrisept Fletcher N, et al: Prevention of perioperative infections. J Bone Joint Surg Am. 2007;89:1605-1618 47
  • 48. IRRISEPT Finally, an alternative to saline and antimicrobial irrigation The first and only FDA-cleared cleansing and debridement system, containing 0.05% Chlorhexidine Gluconate (CHG) in Water for Irrigation IrriSept O.R. (sterile packaging) Irrigation Applicators: Custom designed applicators facilitate cleansing for a variety of applications SplatterGuard® LT SplatterGuard® IrriProbe® 48
  • 49. Review: Bundled Approach to Eliminating SSIs 1. Pre-screen inpatient surgeries for MRSA and Staph aureus (MSSA) using PCR rapid molecular technology 2. Decolonization protocol for MRSA/MSSA positive patients (eg mupirocin 2% ointment 2 x day, daily CHG wash x 5 days) 3. Preoperative shower with CHG (eg Hibiclens) or CHG washcloths (eg Sage) night before/morning of surgery 4. Assure OR standards are being met (traffic control, surgical attire, surgical hand scrub, sterilized instruments, room turnover and terminal cleaning, precautions in OR) 5. Assure surgical prophylaxis is delivered for maximum tissue concentrations 6. Surgical skin prep with CHG/alcohol prep 7. Irrigation with CHG if necessary (eg Irrisept) 8. Antibacterial sutures (eg Ethicon) 9. Incisional Adhesive (octyl cyanoacrylate) (eg Dermabond and Prineo) 10. Post-op incision care instructions 11. Data driven, analysis and calculation of rates, communication/feedback
  • 50. Reducing Risk Factors for SSIs: Tools for success  Institutional support  Senior leadership and “C Suite” involvement  “lead the effort” from top down  Clear goals  Structured program with clearly defined goal of zero tolerance for HAIs  Theoretical foundation to IP Program: Social Learning Theory (Role Modeling, Self Efficacy, Positive Deviance)  Communication – effective and consistent  Ongoing and creative education  Financial support to Infection Prevention program 50