Surgical site infections are a major source of postoperative illness and can increase costs and mortality; Staphylococcus aureus and Staphylococcus epidermidis are the most common pathogens causing SSIs. Using ETHICON Plus antiseptic sutures, which contain triclosan and have been shown to create a zone of inhibition against bacteria, can help control wound contamination during a procedure and continue protecting the patient after leaving the operating room.

1. Superior Protection
DR SREEJOY PATNAIK

2. Understanding Surgical Site Infection
( SSIs)
•Classification
•Causes
•Risk Factor
•Cost & Consequences

3. What Are SSIs?
• SSIs are infections associated with surgical
procedures and are a major source of postoperative
illness
• These infections are responsible for approximately
one quarter of all nosocomial infections and affect
1.4 million people worldwide at any time
• SSIs result in longer hospitalization, increased patient
mortality and higher costs for healthcare providers
and payers
Nichols RL. Emerg Infect Dis. 2001;7:220-224.
World Health Organization. 2002;1-50.

4. Classification of SSI - Definitions
Skin
Hypodermis
Superficial
incisional
wound
Infection occurs within 30 days of
operation and infection involves only skin
or subcutaneous tissue of the incision
Deep soft
tissues
(fascias
& muscle)
Organ
space
Source: CDC Guidelines for Prevention of SSIs1999

5. Superficial Incisional
SSI
Characteristics of Superficial Incisional SSI
Purulent drainage, with or without laboratory confirmation,
from the superficial incision.
Organisms isolated from an aseptically obtained culture
of fluid or tissue from the superficial incision.
At least one of the following signs or symptoms of infection
Pain or tenderness, heat, Localized swelling, redness
Diagnosis of superficial incisional SSI by the surgeon
or attending physician

6. Classification of SSI - Definitions
Skin
Hypodermis
Deep soft
tissues
(fascias
& muscle)
Deep
incisional
wound
Infection occurs within 30 days after the
operation if no ‘implant’ is left in place
or within 1 year if implant is left In place
And the infection appears to be related
to the operation
Organ
space
Source: CDC Guidelines for Prevention of SSIs1999

7. Deep Incisional SSI
Characteristics of Deep Incisional SSI

8. Classification of SSI - Definitions
Skin
Hypodermis
Deep soft
tissues
(fascias
& muscle)
Organ
Organ
space
space
Infection occurs within 30 days after the operation
if no implant is left in place or within 1 year
if implant is in place, and the infection appears
to be related to the operation and infection
involves any part of the anatomy which was
opened or manipulated during the operation
Source: CDC Guidelines for Prevention of SSIs1999

9. Organ/Space
SSI
Characteristics of Organ/Space SSI

10. Pathogens associated with SSIs
http://www.wvdhhr.org/IDEP/pdfs/idep/staphylococcus/resistant_staph_aureus_protocol_07.pdf,
Infection Control and Hospital Epidemiology: SURVEILLANCE PROTOCOL Staphylococcus aureus
Infections of Public Health Significance

11. Pathogens associated with SSIs
–
An Indian Perspective
Abbreviations: MRSA, methicillin-resistant Staphalycoccus aureus; MRSE, methicillin-sensitive Staphalycoccus aureus; NS, not
stated. a Includes surgery of the hydrocele, hernia, appendix, hepatobiliary, breast lungs, thoracic cavity, thyroid, urinary and
genital, oesophageal, gastric and bowels. b Includes caesarean, tubectomy, appendisectomy, prostatectomy, hysterectomy,
orthoreduction, herniorrphy and fasciotomy.

12. Understanding Surgical Site Infection
( SSIs)
•Classification
•Causes
•Risk Factor
•Cost & Consequences

13. CDC Surgical Wound Categories
CDC=Centers for Disease Control and Prevention.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.

14. Incidence of SSI in India – by wound type
Source: Lizioli et al.7

15. Understanding Surgical Site Infection
( SSIs)
•Classification
•Causes
•Risk Factor
•Cost & Consequences

16. Factors in Bacterial Colonization
Leading to SSIs
•
•
•
•
Patient-related
Procedure/Techniques
Postoperative
Implants
Hebert CK et al. Clin Orthop. 1996;331:140-145. Fletcher N et al. J Bone Joint Surg Am. 2007;89:1605-1618.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134. Fry DE. Medscape Surgery. 2003.

17. SSI Risk Factors – Patient Related
•
•
•
•
•
•
•
Advanced age
Malnutrition
Obesity
Diabetes mellitus
History of smoking
Distant infection
Steroid therapy
Sumnicht RW. Med Bull US Army Eur. 1958;15:51-56.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
Fry DE. Medscape Surgery. 2003.
•
•
•
•
•
Chronic inflammation
Open wounds
Radiation
Immunosuppressed
Length of preoperative
stay

18. SSI Risk Factors – Procedures/Techniques
• Duration of operation
• Duration of surgical scrub
• Preoperative shaving,
skin preparation
• Inadequate OR ventilation
• Inadequate sterilization of
instruments
• Surgical technique
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
• Poor hemostasis
• Failure to obliterate dead
space
• Tissue trauma
• Skin antisepsis
• Antimicrobial prophylaxis
• Surgical drains

19. SSI Risk Factors –
Procedures/Techniques Cont’d
•
•
•
•
•
•
•
Length of preoperative hospital stay
Insufficient preoperative preparation
Personal hygiene, hair removal, skin disinfection
Insufficient antibiotic therapy
Intra-operative hypothermia
Intra-operative hypoxemia
Intra-operative hypotension
Nguyen D et al. Infect Cont Hosp Epidemiol. 2001;22:485-492.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
Fry DE. Medscape Surgery. 2003.

20. SSI Postoperative Issues
• Incision care
– Sterile dressing
– Dressing changes (use of sterile technique,
aseptic precautions)
• Discharge planning
– Home incision care
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.

21. Additional Factors Affecting SSI Rates
•
Growing problems
-Emergence of resistant organisms
-More debilitated, elderly, immunocompromised patients; comorbid
disease
-Organ transplants
-Prosthetic implants
•
The risk of SSI can be generally defined as the amount of bacterial
contamination at the site of the infection combined with the virulence, or
degree of pathogenicity, of the bacteria in relation to the immune system
resistance of the patient
Dose of Bacterial Contamination × Virulence
Resistance of the Host Patient
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
= Risk of SSI

22. The Risks of Biofilm
• Biofilm is created when microorganisms like bacteria attach
themselves to living or nonliving surfaces in internal or
external environments
• Postoperative bacteria may contaminate the tissue in a
surgical wound as well as the suture material itself
• Furthermore, the bacteria develop extracellular polymers
that promote greater adhesion and resistance to
antimicrobial treatment
Donlan RM. Emerg Infect Dis. 2001;7:277-281.
Edmiston CE et al. J Am Coll Surg. 2006;203:481-489.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.

23. Implants and SSI
Contamination
Colonization
Biofilm formation
Implant
The result of an implant
becoming contaminated:
• fewer bacteria are required for infection to develop
• implants provide nidus for attachment of the organisms
• the infection is harder to treat because of biofilm formation
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection. Infect Control Hosp Epidemiol, 1999, 27:97-134
Ward KH et al. Mechanism of persistent infection associated with peritoneaI implants. J. Med. Microbiol., vol. 36 (1992), p. 406-413
Nucci C et al. A microbiological and confocal microscopy study documenting a slime-producing Staphylococcus epidermidis isolated from a nylon corneal suture
of a patient with antibiotic-resistant endophthalmitis. Graefe’s Arch Clin Exp Ophthalmol, 2005, 243:951–954

24. Understanding Surgical Site Infection
( SSIs)
•Classification
•Causes
•Risk Factor
•Cost & Consequences

25. Consequences &
Costs Associated With SSIs
Economic Burden of SSIs
Increased hospital stay and costs
Source
Surgery type
Length of post-operative hospital stay
Bhatia 2003
CABG
10 days
SSI
Difference
15 days (mild)
3
No SSI
5 days
19 days
(moderate)
9 days
25 days (severe)
Lilani 2005 5
Elective surgery a
6.19 days
15 days
24.82 days
18.63 days
In India, it is estimated that SSIs increase post-operative hospital stay by 5–18
days and an increase in healthcare costs by upto 30%

26. Additional Costs Associated With SSIs
•
Direct costs
– Prolonged hospitalization,
re-admission
– Outpatient and emergency care
visits
– Additional surgical procedures
• Incision and drainage
• Staged reimplantation
– Prolonged antibiotic therapy
– Increased use of ancillary
services
• Home health visits
• Radiology, laboratory
– Drug costs
– Durable medical equipment
Urban JA. Surg Infect (Larchmt). 2006;7(suppl 1):S19-S22.
•
Indirect costs
– Lost productivity (patient,
family)
– Temporary or permanent
impairment
of physical/mental function
– Decreased patient satisfaction
– Decreased referrals
– Increased litigation

27. Summary
• The major pathogens that lead to SSIs are:
– Staphylococcus aureus
– Staphylococcus epidermidis
– Methicillin-resistant Staphylococcus aureus (MRSA)
– Methicillin-resistant Staphylococcus epidermidis (MRSE)
• Staphylococcus aureus is a major pathogen that leads to
surgical site infection
• SSIs are costly in terms of longer hospitalization and increased
mortality for patients, and higher costs for hospitals
Nichols RL. Emerg Infect Dis. 2001;7:220-224.

28. Objective: Control Microbiologic Risk
Tools
Operating Room
Personnel

29. • Comprehensive infection-control protocols include dozens
of pre-operative, intra-operative, and post-operative
components such as:
 Disinfection of OT
 Skin prep
 Hair removal
 Patient scrubbing
 Antibiotic prophylaxis
 Sterile instruments
 Drapes, gowns, gloves
 Dressing of wound

30. Question:
If all of these measures are employed before,
during, and after the procedure…
what one measure would help control bacterial wound
contamination of the suture during the procedure and inside
the patient?
what one measure would actively provide protection to
the patient after they leave the OR?

31. Answer :
ETHICON Plus SUTURES with Antibacterial
Technology

32. ETHICON Plus SUTURES
Deliver More
• Pharmacology
• IRGACARE® MP (triclosan)
• Plus SUTURES product overview
• Plus SUTURES clinical studies
® Ciba Corporation Inc

33. • Biocompatibility
• Effectiveness against S aureus and S epidermidis
(most common for device infections)
• Ability to withstand manufacturing process
– Heat, humidity, solvent, sterilization, etc
– Ability to mass produce
• Will not negatively alter suture properties
• Maintains antibacterial activity for a clinically relevant
duration
• Cost-effectiveness
Ming X et al. Surg Infect (Larchmt). 2007;8:209-213.

34. ETHICON Plus SUTURES
Deliver More
• Pharmacology
• IRGACARE® MP (triclosan)
• Plus SUTURES product overview
• Plus SUTURES clinical studies
® Ciba Corporation Inc

35. IRGACARE® MP (triclosan) Properties
•
IRGACARE MP
– 2,4,4′ -tri-chloro-2′ hydroxydiphenyl ether
– High-purity material that meets
USP specifications for triclosan,
with minimal residue content
•
IRGACARE MP is safe
– Biocompatible, nontoxic
– Consumer products
• IRGACARE MP is effective
– Active against methicillinsensitive
and methicillin-resistant S
aureus and
S epidermidis (most common
for
device infections)
– Active against Escherichia coli
and Klebsiella pneumoniae
• IRGACARE MP is compatible
with suture processing
– Maintains excellent suture
properties
USP=United States Pharmacopeia.
Zurita R et al. Macromol Biosci. 2006;6:58-69. Ming X et al. Surg Infect (Larchmt). 2007;8:201-207.
Ming X et al. Surg Infect (Larchmt). 2008;9:451-457. Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.
® Ciba Corporation Inc

36. Why IRGACARE® MP (triclosan)?
•
•
•
•
Able to withstand the manufacturing process
Cost-effective
Effective, safe, and compatible
Performance/function properties
– Handling
– Absorption profile, breaking-strength retention
Storch M et al. Surg Infect (Larchmt). 2002;3(suppl 1):S65-S77.
® Ciba Corporation Inc

37. IRGACARE® MP (triclosan): Pharmacokinetics
• Well absorbed after oral administration
• Well distributed in the body
• Rapidly metabolized in liver to the glucuronide/sulfate
conjugate
– T½=10 to 13 hours
• Excreted through kidneys
Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.
® Ciba Corporation Inc

38. IRGACARE® MP (triclosan) and Microbial
Resistance
•
•
•
IRGACARE MP is very effective against S aureus, S epidermidis, and E coli,
which are the 3 most important bacteria related to SSIs
There is no connection between the use of IRGACARE MP and
significant antibiotic resistance
The use of IRGACARE MP may lead to the overall reduction of the
antibiotic burden
– Decreases the risk of SSIs and the resulting application of stronger
antibiotics against SSIs
– The use of IRGACARE MP is not associated with increased bacterial
virulence that raises the antibiotic burden
Ming X et al. Surg Infect (Larchmt). 2007;8:209-213.
Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.
Ford HR et al. Surg Infect (Larchmt). 2005;6:313-321.
® Ciba Corporation Inc

39. ETHICON Plus SUTURES
Deliver More
• Pharmacology
• IRGACARE® MP (triclosan)
• Plus SUTURES product overview
• Plus SUTURES clinical studies
® Ciba Corporation Inc

40. ETHICON Plus SUTURES: Proven
Antibacterial Efficacy Produces a Zone of Inhibition
• In vitro testing (petri dish) has shown Plus Antibacterial
Sutures create a zone of inhibition around the suture in
which certain bacteria are unable to grow
• Coated VICRYL* Plus Antibacterial (polyglactin 910) Suture:
Testing has demonstrated the zone of inhibition lasts in
vitro for a minimum of 7 days for S aureus
• MONOCRYL* Plus Antibacterial (poliglecaprone 25) Suture:
Testing has demonstrated the zone of inhibition lasts in
vitro for 31 days for S aureus and 21 days for E coli
Rothenburger S et al. Surg Infect (Larchmt). 2002;3:S79-S87.
Ming X et al. Surg Infect (Larchmt). 2007;8:201-207.
Ming X et al. Surg Infect (Larchmt). 2008;9:451-457.

41. Plus Antibacterial Sutures
Proven in vitro to create a zone of inhibition around the suture
against the most common surgical site pathogens
Suture with IRGACARE* MP
Rothenburger S, Spangler D, Bhende S, Burkely D. In vitro antibacterial evaluation of coated VICRYL* Plus antibacterial
suture, (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt), 2002, 3:79-87
Ming X, Nichols M, Rothenburger S. In vivo antibacterial efficacy of MONOCRYL* Plus Antibacterial Suture,
(poliglecaprone 25 with triclosan). Surg Infect (Larchmt), 2007, 8:209-213
Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS* Plus (polidioxanone 25 with
triclosan) Suture., Surg Infect (Larchmt), 2008, 9:451-457

42. Breaking Strength: MONOCRYL* Plus
Antibacterial (poliglecaprone 25)
Sutures
†
Data from MONOCRYL Plus Suture package insert.
Data on file. ETHICON, INC.
*Trademark
†
• Wound support for
approximately 14 days
• Consistent absorption
rate with
a predictable decrease in
tensile strength over
time
• Stronger than gut suture
initially and through the
critical wound healing
period

43. Breaking Strength: Coated VICRYL*
Plus
Antibacterial (polyglactin 910)
Suture
†
Data from Coated VICRYL Plus Suture package insert.
Data on file. ETHICON, INC.
*Trademark
†
• Wound support up to
4 weeks

44. ETHICON Plus SUTURES
Deliver More
• Pharmacology
• IRGACARE® MP (triclosan)
• Plus SUTURES product overview
• Plus SUTURES clinical studies
® Ciba Corporation Inc

45. Bacterial Adherence to Surgical Sutures:
Can Antibacterial-coated Sutures Reduce the Risk of Microbial Contamination?
Edmiston CE, Seabrook GR, Goheen MP, et al. J Am Coll Surg. 2006;203:481-489.
Study Results and Conclusions
Adherence of MRSA to noncoated
polyglactin 910 braided suture,
5400x magnification
• This in vitro model demonstrated a significant reduction in gram-positive and gramnegative bacterial adherence to a triclosan-coated braided suture; this reduction was
associated with decreased microbial viability
• Antibacterial efficacy was seen against clinical isolates of MRSA, ESBL-producing E coli, and
biofilm-coated S epidermidis (organisms commonly cultured from surgical wounds)
(A) Mean microbial recovery from noncoated and triclosan-coated polyglactin 910 surgical sutures exposed to bacterial inoculum for 5 seconds, P<0.01.
(B) Mean microbial recovery from noncoated and triclosan-coated polyglactin 910 surgical sutures exposed to bacterial inoculum for 2 minutes, P<0.01.
NP=noncoated polyglactin 910; TP=triclosan-coated polyglactin 910.
Edmiston CE et al. J Am Coll Surg. 2006;203:481-489.

46. Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial Coating on
Coated VICRYL* Plus Antibacterial Suture (Coated Polyglactin 910 Suture With
Triclosan)
Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.
Study Results and Conclusions
Test
Chronic toxicity and carcinogenicity
Genotoxicity
Reproductive toxicity
Immunotoxicity
Cytotoxicity
Intracutaneous reactivity
Material-mediated pyrogenicity
•
•
•
Experimental System
Rat
Hamster
Ames bacterial assay
Mouse lymphoma test
Mouse micronucleus test
Rat
Rabbit
Guinea pig
Human
L-929 fibroblast
Rabbit
Rabbit
Result
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Extensive toxicology database supports the safety of triclosan
Amount of triclosan absorbed from the suture is considerably lower than from consumer
products, making triclosan-coated sutures well suited for their intended indications
In most reasonable estimates for triclosan absorption from consumer products, the
potential total body burden of triclosan is 29 times greater from consumer products than
for sutures (0.088 mg/kg for a 58-kg patient)
Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.

47. In Vitro Antimicrobial Evaluation of Coated VICRYL* Plus Antibacterial Suture
(Coated Polyglactin 910 With Triclosan) Using Zone of Inhibition Assays
Rothenburger S, Spangler D, Bhende S, et al. Surg Infect
(Larchmt). 2002;3(suppl):S79-S87.
•
•
•
Coated polyglactin 910 sutures with
triclosan exhibit antibacterial activity in
vitro against methicillin-sensitive and
-resistant S aureus and S epidermidis
compared with untreated controls
Antibacterial activity endures
despite extended exposure to
aqueous environment
Suture diameter, knotting, or passage
through tissues did not diminish
antibacterial activity of
triclosan-coated sutures
Rothenburger S et al. Surg Infect (Larchmt). 2002;3(suppl):S79-S87.
Suture without triclosan
Suture with triclosan

48. In Vitro Antibacterial Efficacy of
MONOCRYL* Plus Antibacterial Suture (Poliglecaprone 25 With Triclosan)
Ming X, Rothenburger S, Yang D. Surg Infect (Larchmt). 2007;8:201-207.
Study Results and Conclusions
•
Compared to controls, poliglecaprone 25
suture with triclosan [MONOCRYL* Plus
Antibacterial (poliglecaprone 25) Sutures]
provided sustained and stable in vitro
antibacterial efficacy sufficient to inhibit or
reduce in vitro colonization of the suture by:
– S aureus
– MRSA
– S epidermidis
– MRSE
– E coli
– K pneumoniae
•
MONOCRYL Plus Sutures and PDS* Plus
Antibacterial (polydioxanone) Sutures provide
protection against E coli and K pneumoniae
bacteria in addition to the S aureus, S
epidermidis, MRSA, and MRSE strains that are
inhibited by Coated VICRYL* Plus Antibacterial
(polyglactin 910) Sutures
Ming X et al. Surg Infect (Larchmt). 2007;8:201-207.
*Trademark

49. 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)
Ford HR, Jones P, Gaines B, et al. Surg Infect (Larchmt). 2005;6:313-321.
Results
While both sutures performed well—≥94% of responses rated the handling as “very good”
or “excellent”—significantly fewer patients in the triclosan-coated polyglactin 910
group reported pain on day 1 vs the control group (68% vs 89%; P=0.01)
Intraoperative Handling
100
Percent Response
90
80
Good, Fair, Poor
70
Very Good
60
50
Excellent
40
30
20
10
0
VP V
Overall
Handling
VP V
Ease of
Passage
VP V
First
Throw
Ford HR et al. Surg Infect (Larchmt). 2005;6:313-321.
VP V
Tie
Down
VP V
Security
VP V
Hand
VP V
Memory
VP V
Nonfraying

50. Study Conclusions
• In this pediatric cohort of 147 patients, scores for
intraoperative handling were favorable and not significantly
different for
Coated VICRYL* Plus Antibacterial (polyglactin 910) and
Coated VICRYL* (polyglactin 910) Sutures
• Wound healing characteristics comparable between groups
• Incidence of postoperative pain significantly less in patients
treated with Coated VICRYL Plus Sutures compared with
Coated VICRYL Sutures
Ford HR et al. Surg Infect (Larchmt). 2005;6:313-321.

51. References
1.
2.
3.
4.
5.
6.
7.
Agarwal M, Thomas P. Prevalence of post-op. nosocomial infection in neurosurgical patients
and associated risk factors--a prospective study of 2441 patients. The Nursing Journal of India
2003;94(9):197-198, 212.
Ashraf M, Biswas J, Gupta S, et al. Determinants of wound infections for breast procedures:
assessment of the risk of wound infection posed by an invasive procedure for subsequent
operation. Int J Surg 2009 Dec;7(6):543-546.
Bhatia JY, Pandey K, Rodrigues C, et al. Postoperative wound infection in patients undergoing
coronary artery bypass graft surgery: A prospective study with evaluation of risk factors. J
Med Microbiol 2003;21(4):246-251.
Kownhar H, Shankar EM, Vignesh R, et al. High isolation rate of Staphylococcus aureus from
surgical site infections in an Indian hospital [9]. J Antimicrob Chemother 2008;61(3):758-760.
Lilani SP, Jangale N, Chowdhary A, et al. Surgical site infection in clean and cleancontaminated cases. J Med Microbiol 2005;23(4):249-252.
Suchitra JB, Lakshmidevi N. Hospital-acquired infections: Are prevention strategies matching
incidence rates? Healthc Infect 2009;14(1):21-25.
Lizioli A, Privitera G, Alliata E, et al. Prevalence of nosocomial infections in Italy: result from
the Lombardy survey in 2000. J Hosp Infect 2003 Jun;54(2):141-148.