THE IDEAL SURGICAL SUTURE

Superior Protection

DR SREEJOY PATNAIK

•Causes

•Classification

Understanding Surgical Site Infection ( SSIs)

•Risk Factor•Cost & Consequences

• 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.

What Are SSIs?What Are SSIs?

Classification of SSI - DefinitionsClassification of SSI - DefinitionsClassification of SSI - DefinitionsClassification of SSI - Definitions

Source: CDC Guidelines for Prevention of SSIs1999

Infection occurs within 30 days of

operation and infection involves only skin

or subcutaneous tissue of the incision

Skin

Hypodermis

Deep soft tissues (fascias

& muscle)

Organspace

Superficial incisional

wound

Superficial incisional

wound

Superficial Incisional SSISuperficial Incisional SSI

Characteristics of 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



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

Skin

Hypodermis


& muscle)

Organspace

Deepincisional

wound

Deepincisional

wound

Deep Incisional SSIDeep Incisional SSI

Characteristics of Deep Incisional SSICharacteristics of Deep Incisional SSI



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

Skin

Hypodermis


& muscle)

Organ space

Organ

space

Organ

space

Organ/Space SSI

Organ/Space SSI

Characteristics of Organ/Space SSICharacteristics of Organ/Space SSI

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

Pathogens associated with SSIsPathogens associated with SSIs

http://www.wvdhhr.org/IDEP/pdfs/idep/staphylococcus/resistant_staph_aureus_protocol_07.pdf

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.

Pathogens associated with SSIs –

An Indian Perspective

Pathogens associated with SSIs –

An Indian Perspective

•Causes

•Classification



CDC Surgical Wound CategoriesCDC Surgical Wound Categories

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

Source: Lizioli et al.7

Incidence of SSI in India – by wound typeIncidence of SSI in India – by wound type

•Causes

•Classification



• 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.

Factors in Bacterial Colonization

Leading to SSIs

Factors in Bacterial Colonization

Leading to SSIs

• Advanced age• Malnutrition• Obesity• Diabetes mellitus• History of smoking• Distant infection• Steroid therapy

• Chronic inflammation• Open wounds• Radiation• Immunosuppressed• Length of preoperative

stay

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.

SSI Risk Factors – Patient RelatedSSI Risk Factors – Patient Related

• Duration of operation• Duration of surgical scrub• Preoperative shaving,

skin preparation• Inadequate OR ventilation• Inadequate sterilization of

instruments• Surgical technique

• Poor hemostasis• Failure to obliterate dead

space• Tissue trauma• Skin antisepsis• Antimicrobial prophylaxis• Surgical drains

Mangram AJ et al. Am J Infect Control. 1999;27:97-134.

SSI Risk Factors – Procedures/TechniquesSSI Risk Factors – Procedures/Techniques

• 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.

SSI Risk Factors – SSI Risk Factors – Procedures/Techniques ContProcedures/Techniques Cont’’dd

• Incision care– Sterile dressing– Dressing changes (use of sterile technique,

aseptic precautions)• Discharge planning

– Home incision care


SSI Postoperative Issues

• 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


Additional Factors Affecting SSI RatesAdditional Factors Affecting SSI Rates

Dose of Bacterial Contamination VirulenceRisk of SSI=

Resistance of the Host Patient

• 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.

The Risks of BiofilmThe Risks of Biofilm

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection. Infect Control Hosp Epidemiol, 1999, 27:97-134Ward KH et al. Mechanism of persistent infection associated with peritoneaI implants. J. Med. Microbiol., vol. 36 (1992), p. 406-413Nucci 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

Contamination Colonization Biofilm formation

Implant

Implants and SSIImplants and SSI

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

•Causes

•Classification



Economic Burden of SSIs

Increased hospital stay and costs

Source Surgery typeLength of post-operative hospital stay

No SSI SSI Difference

Bhatia 2003 3 CABG 10 days

15 days (mild) 5 days

19 days

(moderate)9 days

25 days (severe) 15 days

Lilani 2005 5 Elective surgery a 6.19 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%

Consequences & Costs Associated With SSIs

Consequences & Costs Associated With SSIs

• Indirect costs– Lost productivity (patient,

family)– Temporary or permanent

impairment of physical/mental function

– Decreased patient satisfaction– Decreased referrals– Increased litigation

• 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.

Additional Costs Associated With SSIsAdditional Costs Associated With SSIs

Nichols RL. Emerg Infect Dis. 2001;7:220-224.

SummarySummary• 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

Personnel

Tool

sO

perating Room

Objective: Control Microbiologic RiskObjective: Control Microbiologic Risk

• 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

Question: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?

Answer :Answer :

ETHICON Plus SUTURES with Antibacterial Technology

® Ciba Corporation Inc

• Pharmacology

ETHICON Plus SUTURES Deliver More


• Plus SUTURES clinical studies

• Plus SUTURES product overview

• IRGACARE® MP (triclosan)

• 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.


• Pharmacology





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

IRGACAREIRGACARE®® MP (triclosan) Properties 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 methicillin-

sensitive 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

• 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

Why IRGACAREWhy IRGACARE®® MP (triclosan)? MP (triclosan)?

• 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

IRGACARE® MP (triclosan): PharmacokineticsIRGACARE® MP (triclosan): Pharmacokinetics

• 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

IRGACAREIRGACARE®® MP (triclosan) and Microbial MP (triclosan) and Microbial ResistanceResistance


• Pharmacology






• 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.

ETHICON Plus SUTURES: Proven ETHICON Plus SUTURES: Proven Antibacterial Efficacy Produces a Zone of InhibitionAntibacterial Efficacy Produces a Zone of Inhibition

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, 3:79-87Ming X, Nichols M, Rothenburger S. In vivo antibacterial efficacy of MONOCRYL* Plus Antibacterial Suture, (poliglecaprone 25 with triclosan). Surg Infect (Larchmt), 2007, 8:209-213Ming 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

Plus Antibacterial SuturesPlus Antibacterial Sutures

Proven in vitro to create a zone of inhibition around the suture against the most common surgical site pathogens

• 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

†

†Data from MONOCRYL Plus Suture package insert.Data on file. ETHICON, INC.*Trademark

Breaking Strength: MONOCRYL* Plus Antibacterial (poliglecaprone 25)

Sutures

Breaking Strength: MONOCRYL* Plus Antibacterial (poliglecaprone 25)

Sutures

• Wound support up to 4 weeks

†

†Data from Coated VICRYL Plus Suture package insert.Data on file. ETHICON, INC.*Trademark

Breaking Strength: Coated VICRYL* Plus

Antibacterial (polyglactin 910) Suture

Breaking Strength: Coated VICRYL* Plus

Antibacterial (polyglactin 910) Suture


• Pharmacology






Edmiston CE, Seabrook GR, Goheen MP, et al. J Am Coll Surg. 2006;203:481-489.

Study Results and Conclusions

• This in vitro model demonstrated a significant reduction in gram-positive and gram-negative 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)

Adherence of MRSA to noncoated polyglactin 910 braided suture, 5400x magnification

(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.

Bacterial Adherence to Surgical Sutures: Can Antibacterial-coated Sutures Reduce the Risk of Microbial Contamination?

Bacterial Adherence to Surgical Sutures: Can Antibacterial-coated Sutures Reduce the Risk of Microbial Contamination?

Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.Study Results and Conclusions

• 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)

Test Experimental System Result

Chronic toxicity and carcinogenicity Rat NegativeHamster Negative

GenotoxicityAmes bacterial assay NegativeMouse lymphoma test NegativeMouse micronucleus test Negative

Reproductive toxicity Rat NegativeRabbit Negative

Immunotoxicity Guinea pig NegativeHuman Negative

Cytotoxicity L-929 fibroblast NegativeIntracutaneous reactivity Rabbit NegativeMaterial-mediated pyrogenicity Rabbit Negative

Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.

Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial Coating on Chemistry and Safety of Triclosan, and Its Use as an Antimicrobial Coating on Coated VICRYL* Plus Antibacterial Suture (Coated Polyglactin 910 Suture With Coated VICRYL* Plus Antibacterial Suture (Coated Polyglactin 910 Suture With

Triclosan)Triclosan)

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

Suture without triclosan

Suture with triclosan

Rothenburger S et al. Surg Infect (Larchmt). 2002;3(suppl):S79-S87.

In Vitro Antimicrobial Evaluation of Coated VICRYL* Plus Antibacterial Suture (Coated Polyglactin 910 With Triclosan) Using Zone of Inhibition Assays

In Vitro Antimicrobial Evaluation of Coated VICRYL* Plus Antibacterial Suture (Coated Polyglactin 910 With Triclosan) Using Zone of Inhibition Assays

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

In Vitro Antibacterial Efficacy of MONOCRYL* Plus Antibacterial Suture (Poliglecaprone 25 With Triclosan)

In Vitro Antibacterial Efficacy of MONOCRYL* Plus Antibacterial Suture (Poliglecaprone 25 With Triclosan)

Ford HR, Jones P, Gaines B, et al. Surg Infect (Larchmt). 2005;6:313-321.

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)

Ford HR et al. Surg Infect (Larchmt). 2005;6:313-321.

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)

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)

Results

VP V

10

20

30

40

50

60

70

80

90

100

VP V VP V VP V VP V VP V VP V VP VOverall

HandlingEase ofPassage

First Throw

TieDown

Security Hand Memory Non-fraying

Perc

ent R

espo

nse

0

Good, Fair, Poor

Very Good

Excellent

Intraoperative Handling

• 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.

Study Conclusions

References1. 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.

2. 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.

3. 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.

4. 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.

5. Lilani SP, Jangale N, Chowdhary A, et al. Surgical site infection in clean and clean-contaminated cases. J Med Microbiol 2005;23(4):249-252.

6. Suchitra JB, Lakshmidevi N. Hospital-acquired infections: Are prevention strategies matching incidence rates? Healthc Infect 2009;14(1):21-25.

7. 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.

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THE IDEAL SURGICAL SUTURE

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