SSI risk can be addressed bySSI risk can be addressed by controlling risk factors 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

1

Controlled Risks Potentially Uncontrolled Risks Scrubbing in Gowning Skin antisepsis Controlling OR environment Sterilizing instruments Using minimally invasive techniques

☐ Bacterial colonization of the suture☐ Contamination of the incisional site

after the wound is closed☐ Entry of bacteria from the skin during

wound closure☐ Bacterial infiltration due to dehiscence

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

2

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

1. Ward KH et al. J Med Microbiol. 1992;36: 406-413.2. Kathju S et al Surg infect. 2009;10:457-4613. Mangram AJ et al. Infect Control Hosp Epidemiol.1999;27:97-134..

Contamination Colonization Biofilm Formation

Why Antimicrobial Suture?Why Antimicrobial Suture?OR Air Current ContaminationOR Air Current Contamination

In teaching hospitals:

Surgeon leaves roomResident, Physician Assistant or Nurse Practitioner work on incisionCirculating Nurse counts sponges and starts room breakdownScrub Technician starts breaking down tables and preparing instruments for Central ProcessingAnesthesia move in and out of roomInstrument representative might leave room and Visitors may leave room

Suture with Staphylococcus colonies

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

Potential for Contamination of SuturesPotential for Contamination of Sutures at End of Caseat End of Case

Antibacterial Sutures: Antibacterial Sutures: Impact in a Real-World SettingImpact in a Real-World Setting

• Antimicrobial 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

55 day zone of inhibition 10 day zone of inhibition

Traditional suture

Antimicrobial suture

Plus Antibacterial Sutures: Plus Antibacterial Sutures: Impact in a Real-World SettingImpact 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

– Reduction in total joint infections rate during trial period

– Infection rate dropped from 0.44% to 0.33% with three less infections

6 Spencer M, et al: Reducing the Risk of Orthopedic Infections: The Role of Innovative Suture Technology

NAON Poster Presentation - 2010

Triclosan-coated sutures for the reduction of sternal Triclosan-coated sutures for the reduction of sternal wound infection wound infection Fleck et al., Ann Thoracic Surg. 2007Fleck et al., Ann Thoracic Surg. 2007

• 479 patients – CABG, Valve, CABG-Valve, Redo • 376 conventional closure; 103 impregnated technology

• IV ABX Prophylaxis – 30 minutes prior to incision

• 24 sternal wound infections in conventional closure group (10 superficial; 14 deep – MSSA, MRSA, MSSE, Enterococcus)

• No infections observed in impregnated closure group

• Economic consideration – “increase in suture cost was negligible if even one sternal wound infection can be prevented”

Antibiotic coating of abdominal closure sutures and Antibiotic coating of abdominal closure sutures and wound infection wound infection Justinger et al 2009Justinger et al 2009

• 2,088 abdominal operations via midline incision.

• Prospective cohort comparison PDS II loop suture vs Vicryl plus• No other changes in protocols of patient care.• Risk factors for SSI were comparable between the 2 groups.

• Primary outcome was the number of wound infections.

• PDS SSI 10.8% vs. Vicryl plus SSI 4.9% (p < .001)

Innovative wound closure technologiesInnovative wound closure technologiescan address risk factors for SSIscan address risk factors for SSIs

• Topical Skin Adhesive provides a microbial barrier during the critical wound healing period

10

SSI Risk Factor Innovative Technology

Bacterial colonization of the suture Contamination of the incisional site

after the wound is closed Entry of bacteria from the skin during

wound closure Bacterial infiltration due to dehiscence

Antibacterial Sutures Chlorhexidine/alcohol skin prep Prevention of Dehiscence and

Exogenous Contamination with Topical Skin Adhesive or Antimicrobial Dressings

Post-op Skin Issues in OrthopedicsPost-op Skin Issues in Orthopedics

Anterior fusion with tape burns

Posterior fusion with contaminated steri-strips

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. Bash 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.

Evidence-Based Performance

ProductTotal Number

of RCTsTotal Number of Patients Treated

DERMABOND® Topical Skin Adhesive 40 4075

Histoacryl® 6 534

INDERMIL® 2 150

LiquiBand® 1 78

SurgiSeal® 0 0

derma+flex® QS™ (octylseal™) 0 0

• The largest randomized clinical trial database of any TSA– 8x the number of patients vs the leading competitor

RCTs only; reasons for exclusion were language of publication other than German or English, nonhuman studies, case series or case reports, and inappropriate indication.

No RCTs identified for any other competitors.

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

Selected Publications: DERMABOND® Topical Skin Adhesive in Orthopedic Surgery

Procedure Reference No. of Patients Key Findings

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

Lumbar and cervical spine procedures2 Hall and Bailes. 2005 200

Retrospective

• Patients followed for >5 months• Only 1 documented SSI• High patient satisfaction

Total hip arthroplasty for femoral neck fracture3

Kregor et al. 2008 Retrospective

• Surgeon preference to reduce urinary and fecal contamination of wound 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.

16

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

New, innovative, minimally invasiveDERMABOND™ PRINEO™ Skin Closure System

1. DERMABOND™ PRINEO™ IFU. PM72449C. STATUS 6/2010.2. Shapiro AJ et al. Am Surg. 2001;67(11): 1113 1115. ‐3. Data on file. Ethicon, Inc.

DERMABOND™ PRINEO™ removal

Patient is shown 2 weeks after circumferential body lift and immediately after removal of DERMABOND™ PRINEO™ Skin Closure System.