Transcript Evidence-Based Performance

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
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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
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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
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2.
3.
Colonization
Biofilm Formation
Ward KH et al. J Med Microbiol. 1992;36: 406-413.
Kathju S et al Surg infect. 2009;10:457-461
Mangram AJ et al. Infect Control Hosp Epidemiol.1999;27:97-134..
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Why Antimicrobial 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
Antibacterial Sutures:
Impact 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
Traditional suture
Antimicrobial suture
5 day zone of inhibition
10 day zone of inhibition
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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
– Reduction in total joint infections rate during trial
period
– Infection rate dropped from 0.44% to 0.33% with three
less infections
NAON Poster Presentation - 2010
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Spencer M, et al: Reducing the Risk of Orthopedic Infections: The Role of Innovative Suture Technology 6
Triclosan-coated sutures for the reduction of sternal
wound infection Fleck 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
wound infection Justinger 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 technologies
can address risk factors for SSIs
• Topical Skin Adhesive provides a microbial barrier during the
critical wound healing period
SSI Risk Factor
 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
Innovative Technology
 Antibacterial Sutures
 Chlorhexidine/alcohol skin prep
 Prevention of Dehiscence and
Exogenous Contamination with Topical
Skin Adhesive or Antimicrobial
Dressings
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Post-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
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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)
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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.
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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
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The largest randomized clinical trial database of any TSA
– 8x the number of patients vs the leading competitor
Product
DERMABOND®
Topical Skin Adhesive
Total Number
of RCTs
Total Number of
Patients Treated
40
4075
Histoacryl®
6
534
INDERMIL®
2
150
LiquiBand®
1
78
SurgiSeal®
0
0
derma+flex® QS™
(octylseal™)
0
0
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
Selected Publications: DERMABOND® Topical Skin
Adhesive in Orthopedic Surgery
Procedure
Primary hip
Reference
arthroplasty1
Lumbar and cervical spine
procedures2
Total hip arthroplasty for
femoral neck fracture3
Khurana et al. 2008
Hall and Bailes. 2005
Kregor et al. 2008
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.
No. of Patients
Key Findings
93
• Patients followed for >7 months
• No infections
• 1 wound dehiscence
200
Retrospective
• Patients followed for >5 months
• Only 1 documented SSI
• High patient satisfaction
Retrospective
• Surgeon preference to reduce urinary
and fecal contamination of wound
and allow patients to shower
immediately
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
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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.