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Sutures
Briefly…
Definition of suture:
1. A strand of material that is used to approximate tissues or to ligate blood
   vessels during the wound-healing period (Ratner et al. 2004).
2. A stitch or row of stitches holding together the edges of a wound or
   surgical incision (Oxford Dictionary).

Tools:
1. Needle
2. Suture material
The Needle…
• Traditionally used stainless steel alloys 300 and 420
• Modern needle uses 455 for superior properties (Ratner et.al. 2004)

Chemical Composition           420             300          455
Fe                           Majority        Majority       73%
C                            < 0.15%         < 0.08%      < 0.05%
Cr                           12 – 14%       17.5 – 20%     11.8%
Ni                                           8 – 11%       8.5%
Cu, Nb, Ti                                               2, 2, 1.1 %
Mn                             < 1%           < 2%        < 0.5%
Si                             < 1%           < 1%        < 0.5%
P                            < 0.04%        < 0.045%     < 0.004%
S                            > 0.03%         < 0.03 %     < 0.03%
Density (kg/m3)               7750            8000         7800
Elastic Modulus (Gpa)          200             193          200
Specific Heat (J/kg.K)         460             500          N/A
Tensile Strength (Mpa)         655             205          965

                         Source: Azom.com
The Needle…




Source: Suture Technical Specifications, Demetech (http://www.demetech.us/suture-specs.php)
Classifying Suture Material…

                                           Natural
                     Origin
                                           Synthetic


                                          Absorbable
  Sutures         Absorption
                                         Nonabsorbabl
                                              e


                                         Multifilament
                    Fiber
                 construction
                                         Monofilament


            Source: Ratner et al. 2004
Classifying Suture Material…




Vicryl                    Silk
Synthetic, Absorbable     Natural, non-absorbable
Classifying Suture Material…

Fiber construction




    Source: Suture Technical Specifications, Demetech (http://www.demetech.us/suture-specs.php)
Classifying Suture Material…
Suture Types         Generic Structure               Classification                Representative
                                                                                   Product/Brand
Catgut               Collagen from animal            Natural, absorbable, twisted Surgical Gut,
                     intestines                      multifilament (mono.)        Chromic Gut
Silk                 Fibroin from silkworm           Natural, non-absorbable,      Perma-Head,
                     Bombyx mori                     braid multifilament           Softsilk
Polypropylene        Isotactic crystalline           Synthetic, non-absorbable,    Prolene, Surgipro
                     stereoisomer of PP              monofilament
Polyamide            Nylon 6 and nylon 6,6           Synthetic, non-absorbable,    Ethilon, Dermalon
                                                     monofilament
Stainless steel      316L (low carbon) stainless     Metal, non-absorbable,        Ethisteel, Flexon
                     steel alloy                     mono and multifilament
Polyglycolic acid/   90% PGA, 10% PLA                Synthetic, absorbable,        Vicryl, Vicryl
Polylactic acid                                      braided multifilament         Rapide
Polydioxanone        Polyester p-dioxanone           Synthetic, absorbable,        PDS II
                                                     monofilament
Polyglycolic acid/   Copolymer of glycolic acid      Synthetic, absorbable,        Maxon
Polytrimethylene     and trimethylene carbonate      monofilament
carbonate
                                         Source: Ratner et al. 2004
A Truly, Ideal Suture Material?


               Does Not Exist, BUT…



Sterile, highly uniform tensile strength, predictable
 performance, non-capillary, non-allergic, easy to
     handle, minimal tissue reaction, absorbed
                      completely
Properties of Suture Material…
                                Properties


     Physical                    Handling                    Biological


                            Knot-tie down, First                Tissue
  Tensile Strength,
                             throw hold, Tissue          reaction, Absorptio
 Dimension, Knot-
                               drag, Package             n, Biocompatibility,
 pull strength, Knot
                                 memory,                   Tensile strength
 security, Stiffness
                                Suppleness                       loss


• All standards, test procedures and product specifications are set by U.S.
  Pharmacopeia (U.S.P.)
Properties: Size and Dimension
• Smallest diameter possible to minimize the amount of
  material drawn on tissue
• Size ranges from #5 (largest) to #11-0 (smallest)

 USP     Synthetic:       Collagen:          USP      Synthetic:       Collagen:
         Diameter         Diameter                    Diameter         Diameter
         (mm)             (mm)                        (mm)             (mm)
 11-0    0.01 – 0.019                        3-0      0.2 – 0.249      0.3 – 0.349
 10-0    0.02 – 0.029                        2-0      0.3 – 0.349      0.35 – 0.399
 9-0     0.03 – 0.039     0.04 – 0.049       0        0.35 – 0.399     0.4 – 0.499
 8-0     0.04 – 0.049     0.05 – 0.069       1        0.4 – 0.499      0.5 – 0.599

 7-0     0.05 – 0.069     0.07 – 0.099       2        0.5 – 0.599      0.6 – 0.699

 6-0     0.07 – 0.099     0.1 – 0.149        3        0.6 – 0.699      0.7 – 0.799
                                             4                         0.8 – 0.899
 5-0     0.1 – 0.149      0.15 – 0.199
                                             5        0.70 – 0.799
 4-0     0.15 – 0.199     0.2 – 0.249
  Source: US Pharmacopeia (http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html)
Properties: Knot pull tensile strength
• Maximum tensile stress that can be applied on the ears of a
  knot (Ratner et al. 2004)
• The larger the diameter, the higher the knot pull tensile
  strentgh

 USP     Synthetic        Collagen*         USP      Synthetic        Collagen*
 11-0                                       3-0            17.4             12.2
 10-0         0.24                          2-0            26.3             19.6
 9-0          0.49                          0              38.2             27.2
 8-0          0.69             0.44         1              49.8             37.3
 7-0          1.37             0.69         2              62.3             44.2
 6-0          2.45             1.76         3              71.5             57.8
 5-0          6.67             3.73
                                            4                               68.6
 4-0          9.32             7.55
                            *Based on limit on average minimum
  Source: US Pharmacopeia (http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html)
Properties: Tensile Strength Loss…
• The loss of tensile strength as a function of time (Ratner et al.
  2004)




                        Source: Ratner et al. 2004
Properties: Absorption…
• Enzymatic and/pr hydrolytic breakdown of a strand followed
  by elimination (Ratner et al. 2004)




                       Source: Ratner et al. 2004
Properties: Strain, Stiffness
• Strain: Ratio of the change in length of a material to the initial
  unstressed reference length (Helmenstine 2012)
• Stiffness: Resistance of an elastic body to deflection or deformation by
  an applied force (Engineering Toolbox)


   PE


 PET

 PET

PGA/PLLA




                             Source: Najibi et al. 2001
Properties: In summary…
• Knot security: Force that a knot can withstand before slipping or untying
  (Ratner et al. 2004)


Suture Types      Knot pull   Knot            Handling        Tissue       In vivo strength
                  strength    security                        reactivity   loss
Catgut            Poor        Poor (plain)    Fair            High         7-10 days (plain),
                              Fair                                         21-28 days
                              (chromic)                                    (chromic)
Silk              Fair        Good            Very good       High         1 year
Polypropylene     Fair        Poor            Poor            Low          Indefinite
Polyamide         Fair        Fair            Good            Low          1.5 – 2.5% /year
Stainless steel   High        Good            Poor            Low          Indefinite
PGA/PLLA          Good        Fair -good      Good            Low          10 days – 4 weeks
Polydioxanone     Fair -good Poor-fair        Fair-good       Low          10 days – 6 weeks

                                 Source: Ratner et al. 2004
Wound Healing…
                                            Usually clean,
                    Primary Intention     uninfected, surgical
                                                wound
Wound healing
                                           Cell or tissue loss
                                         more extensive due to
                   Secondary Intention
                                         injury, malignancy or
                                                infection




                     Source: Dunn 2007
Interaction with Biological System + Host Reaction
 Tissue Reaction
 • Immune system considers all suture threads to be foreign bodies
 • Inflammatory response occurs is similar to any reaction towards
   foreign body
 • Reaction depends on the type of suture, texture, degree of tissue
   trauma and length of implantation (Braun & Aesculap t.th)

 (Postlethwait et al. 1975):
 • Catgut >> encourage formation of thin connective tissue, histiocytes
    and lymphocytes and cellular infiltrations >> complete absorption
    leaves
 • Silk >> formation of fibrous tissue capsule with variety of giant cells
    presence, with latter invasion of histiocytes and fibtoblasts
 • Nylon >> narrow fibrous tissue zone, least reaction seen
Interaction with Biological System + Host Reaction
 Grades of Tissue Reaction




                     (Source: Postlethwait et al. 1975)




GlOD, Gut 10 days,       G19D, Gut 19 days,               GIl Y, Gut 11 years,
gastroenterostomy.       subcuitaneotus.                  vaginal cuff closure.
Essentially no           Absorption beginning,            No absorption or
                         mainly by monocytes.             reaction.
reaction.
                         Serrations at edges and
                         one cleft in suture.
Interaction with Biological System + Host Reaction




 Coated Vicryl Rapid ®, 7 days,
 presence of multinucleated giant
 cells between filaments of
 suture
                SEM of Coated Vicryl Rapid ®,
                Series of absorption occurs (A)
                implantation (B) 7 days post and
                (C) 14 days post.

         Source: Andrade & Weissman 2005
Interaction with Biological System + Host Reaction

   Let’s Recap on the Biological Properties

    Suture Types      Tissue reactivity       In vivo strength loss
    Catgut            High                    7-10 days (plain), 21-28 days
                                              (chromic)
    Silk              High                    1 year
    Polypropylene     Low                     Indefinite
    Polyamide         Low                     1.5 – 2.5% /year
    Stainless steel   Low                     Indefinite
    PGA/PLLA          Low                     10 days – 4 weeks
    Polydioxanone     Low                     10 days – 6 weeks




                            Source: Ratner et al. 2004
Risks & Side Effects…

1. Suture knot slipping
   • Inability of the suture to retain until wound healing complete
   • Common in absorbable suture
2. Re-infection
   • Site for microbial growth causing re-infection
   • the need for suture with antimicrobial activity
3. Failure of wound healing
   • Improper suturing technique does not allow collagen formation
Future Development
• Limited to products that can demonstrate a
  performance benefit due to cost-
  constrained market
• Continue development of multifilament
  braid coatings to provide the best suture
  possible
• Need to have an ideal absorbable suture
  should only degrades rapidly following loss
  of tensile strength
• Development of more suture with
  antimicrobial properties:
                                                        INNOVATION
    • Vicryl Plus (contains triclosan or 5-
       chloro-2-(2,4-dichlorophenoxy)phenol)            PROSPECT
• More commercialized non-suture products                DEMAND
  like tissue sealant made of fibrin glue

                           Source: Ratner et al. 2004
References
1. Andrade, M.G.S. & Weissman, R. 2005. Tissue Reaction and Surface Morphology of
    Absorbable Sutures after In Vivo Exposure. Journal of Material Science: Material Medicine
    17:949-961.
2. Braun & Aesculap. 2006. Suture
    Glossary.http://www.themonofilamentadvantage.com/documents/Training/Glossary_Sutures
    _neu.pdf
3. Chrimax. 2001. Non-absrobable Materials: Reaction in Tissue.
    http://www.chirmax.cz/chirmax_multi/index.php?stranka_id=21&jazyk=3j
4. Dunn, D.L. 2007. Wound Closure Manual. Johnson & Johnson.
    http://surgery.uthscsa.edu/pediatric/training/woundclosuremanual.pdf
5. Engineering Toolbox. 2012. Stiffness. http://www.engineeringtoolbox.com/stiffness-
    d_1396.html
6. Helmenstine, A.M. 2012. Strain. About.com Chemistry.
    http://chemistry.about.com/od/engineeringglossary/g/strain-definition.htm
7. Najibi, S., Banglmeier, R., Matta, J.M. & Tannast, M. 2001. Material Properties of Common
    Suture Materials in Orthopaedic Surgery. The Iowa Orthopaedic Journal 30:84-88.
8. Postlethwait, R.W., Willigan, D.A. & Ulin, A.W. 1975. Human Tissue Reaction to Sutures.
    Annals of Surgery 181(2):144-150
9. Ratner, B.D., Hoffman, A.S., Schoen, F.J. & Lemons, J.E. 2004. Surface Properties and Surface
    Characterization of Materials. Biomaterial Science: An Introduction to Material in Medicine.
    2nd Edition. San Diego: Elsevier
10. Salhan, S & Dass, A. 2012. Textbook of Gynecology. New Delhi: Jaypee Brothers Medical.
11. US Pharmacopeia. http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html
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Sutures

  • 2. Briefly… Definition of suture: 1. A strand of material that is used to approximate tissues or to ligate blood vessels during the wound-healing period (Ratner et al. 2004). 2. A stitch or row of stitches holding together the edges of a wound or surgical incision (Oxford Dictionary). Tools: 1. Needle 2. Suture material
  • 3. The Needle… • Traditionally used stainless steel alloys 300 and 420 • Modern needle uses 455 for superior properties (Ratner et.al. 2004) Chemical Composition 420 300 455 Fe Majority Majority 73% C < 0.15% < 0.08% < 0.05% Cr 12 – 14% 17.5 – 20% 11.8% Ni 8 – 11% 8.5% Cu, Nb, Ti 2, 2, 1.1 % Mn < 1% < 2% < 0.5% Si < 1% < 1% < 0.5% P < 0.04% < 0.045% < 0.004% S > 0.03% < 0.03 % < 0.03% Density (kg/m3) 7750 8000 7800 Elastic Modulus (Gpa) 200 193 200 Specific Heat (J/kg.K) 460 500 N/A Tensile Strength (Mpa) 655 205 965 Source: Azom.com
  • 4. The Needle… Source: Suture Technical Specifications, Demetech (http://www.demetech.us/suture-specs.php)
  • 5. Classifying Suture Material… Natural Origin Synthetic Absorbable Sutures Absorption Nonabsorbabl e Multifilament Fiber construction Monofilament Source: Ratner et al. 2004
  • 6. Classifying Suture Material… Vicryl Silk Synthetic, Absorbable Natural, non-absorbable
  • 7. Classifying Suture Material… Fiber construction Source: Suture Technical Specifications, Demetech (http://www.demetech.us/suture-specs.php)
  • 8. Classifying Suture Material… Suture Types Generic Structure Classification Representative Product/Brand Catgut Collagen from animal Natural, absorbable, twisted Surgical Gut, intestines multifilament (mono.) Chromic Gut Silk Fibroin from silkworm Natural, non-absorbable, Perma-Head, Bombyx mori braid multifilament Softsilk Polypropylene Isotactic crystalline Synthetic, non-absorbable, Prolene, Surgipro stereoisomer of PP monofilament Polyamide Nylon 6 and nylon 6,6 Synthetic, non-absorbable, Ethilon, Dermalon monofilament Stainless steel 316L (low carbon) stainless Metal, non-absorbable, Ethisteel, Flexon steel alloy mono and multifilament Polyglycolic acid/ 90% PGA, 10% PLA Synthetic, absorbable, Vicryl, Vicryl Polylactic acid braided multifilament Rapide Polydioxanone Polyester p-dioxanone Synthetic, absorbable, PDS II monofilament Polyglycolic acid/ Copolymer of glycolic acid Synthetic, absorbable, Maxon Polytrimethylene and trimethylene carbonate monofilament carbonate Source: Ratner et al. 2004
  • 9. A Truly, Ideal Suture Material? Does Not Exist, BUT… Sterile, highly uniform tensile strength, predictable performance, non-capillary, non-allergic, easy to handle, minimal tissue reaction, absorbed completely
  • 10. Properties of Suture Material… Properties Physical Handling Biological Knot-tie down, First Tissue Tensile Strength, throw hold, Tissue reaction, Absorptio Dimension, Knot- drag, Package n, Biocompatibility, pull strength, Knot memory, Tensile strength security, Stiffness Suppleness loss • All standards, test procedures and product specifications are set by U.S. Pharmacopeia (U.S.P.)
  • 11. Properties: Size and Dimension • Smallest diameter possible to minimize the amount of material drawn on tissue • Size ranges from #5 (largest) to #11-0 (smallest) USP Synthetic: Collagen: USP Synthetic: Collagen: Diameter Diameter Diameter Diameter (mm) (mm) (mm) (mm) 11-0 0.01 – 0.019 3-0 0.2 – 0.249 0.3 – 0.349 10-0 0.02 – 0.029 2-0 0.3 – 0.349 0.35 – 0.399 9-0 0.03 – 0.039 0.04 – 0.049 0 0.35 – 0.399 0.4 – 0.499 8-0 0.04 – 0.049 0.05 – 0.069 1 0.4 – 0.499 0.5 – 0.599 7-0 0.05 – 0.069 0.07 – 0.099 2 0.5 – 0.599 0.6 – 0.699 6-0 0.07 – 0.099 0.1 – 0.149 3 0.6 – 0.699 0.7 – 0.799 4 0.8 – 0.899 5-0 0.1 – 0.149 0.15 – 0.199 5 0.70 – 0.799 4-0 0.15 – 0.199 0.2 – 0.249 Source: US Pharmacopeia (http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html)
  • 12. Properties: Knot pull tensile strength • Maximum tensile stress that can be applied on the ears of a knot (Ratner et al. 2004) • The larger the diameter, the higher the knot pull tensile strentgh USP Synthetic Collagen* USP Synthetic Collagen* 11-0 3-0 17.4 12.2 10-0 0.24 2-0 26.3 19.6 9-0 0.49 0 38.2 27.2 8-0 0.69 0.44 1 49.8 37.3 7-0 1.37 0.69 2 62.3 44.2 6-0 2.45 1.76 3 71.5 57.8 5-0 6.67 3.73 4 68.6 4-0 9.32 7.55 *Based on limit on average minimum Source: US Pharmacopeia (http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html)
  • 13. Properties: Tensile Strength Loss… • The loss of tensile strength as a function of time (Ratner et al. 2004) Source: Ratner et al. 2004
  • 14. Properties: Absorption… • Enzymatic and/pr hydrolytic breakdown of a strand followed by elimination (Ratner et al. 2004) Source: Ratner et al. 2004
  • 15. Properties: Strain, Stiffness • Strain: Ratio of the change in length of a material to the initial unstressed reference length (Helmenstine 2012) • Stiffness: Resistance of an elastic body to deflection or deformation by an applied force (Engineering Toolbox) PE PET PET PGA/PLLA Source: Najibi et al. 2001
  • 16. Properties: In summary… • Knot security: Force that a knot can withstand before slipping or untying (Ratner et al. 2004) Suture Types Knot pull Knot Handling Tissue In vivo strength strength security reactivity loss Catgut Poor Poor (plain) Fair High 7-10 days (plain), Fair 21-28 days (chromic) (chromic) Silk Fair Good Very good High 1 year Polypropylene Fair Poor Poor Low Indefinite Polyamide Fair Fair Good Low 1.5 – 2.5% /year Stainless steel High Good Poor Low Indefinite PGA/PLLA Good Fair -good Good Low 10 days – 4 weeks Polydioxanone Fair -good Poor-fair Fair-good Low 10 days – 6 weeks Source: Ratner et al. 2004
  • 17. Wound Healing… Usually clean, Primary Intention uninfected, surgical wound Wound healing Cell or tissue loss more extensive due to Secondary Intention injury, malignancy or infection Source: Dunn 2007
  • 18. Interaction with Biological System + Host Reaction Tissue Reaction • Immune system considers all suture threads to be foreign bodies • Inflammatory response occurs is similar to any reaction towards foreign body • Reaction depends on the type of suture, texture, degree of tissue trauma and length of implantation (Braun & Aesculap t.th) (Postlethwait et al. 1975): • Catgut >> encourage formation of thin connective tissue, histiocytes and lymphocytes and cellular infiltrations >> complete absorption leaves • Silk >> formation of fibrous tissue capsule with variety of giant cells presence, with latter invasion of histiocytes and fibtoblasts • Nylon >> narrow fibrous tissue zone, least reaction seen
  • 19. Interaction with Biological System + Host Reaction Grades of Tissue Reaction (Source: Postlethwait et al. 1975) GlOD, Gut 10 days, G19D, Gut 19 days, GIl Y, Gut 11 years, gastroenterostomy. subcuitaneotus. vaginal cuff closure. Essentially no Absorption beginning, No absorption or mainly by monocytes. reaction. reaction. Serrations at edges and one cleft in suture.
  • 20. Interaction with Biological System + Host Reaction Coated Vicryl Rapid ®, 7 days, presence of multinucleated giant cells between filaments of suture SEM of Coated Vicryl Rapid ®, Series of absorption occurs (A) implantation (B) 7 days post and (C) 14 days post. Source: Andrade & Weissman 2005
  • 21. Interaction with Biological System + Host Reaction Let’s Recap on the Biological Properties Suture Types Tissue reactivity In vivo strength loss Catgut High 7-10 days (plain), 21-28 days (chromic) Silk High 1 year Polypropylene Low Indefinite Polyamide Low 1.5 – 2.5% /year Stainless steel Low Indefinite PGA/PLLA Low 10 days – 4 weeks Polydioxanone Low 10 days – 6 weeks Source: Ratner et al. 2004
  • 22. Risks & Side Effects… 1. Suture knot slipping • Inability of the suture to retain until wound healing complete • Common in absorbable suture 2. Re-infection • Site for microbial growth causing re-infection • the need for suture with antimicrobial activity 3. Failure of wound healing • Improper suturing technique does not allow collagen formation
  • 23. Future Development • Limited to products that can demonstrate a performance benefit due to cost- constrained market • Continue development of multifilament braid coatings to provide the best suture possible • Need to have an ideal absorbable suture should only degrades rapidly following loss of tensile strength • Development of more suture with antimicrobial properties: INNOVATION • Vicryl Plus (contains triclosan or 5- chloro-2-(2,4-dichlorophenoxy)phenol) PROSPECT • More commercialized non-suture products DEMAND like tissue sealant made of fibrin glue Source: Ratner et al. 2004
  • 24. References 1. Andrade, M.G.S. & Weissman, R. 2005. Tissue Reaction and Surface Morphology of Absorbable Sutures after In Vivo Exposure. Journal of Material Science: Material Medicine 17:949-961. 2. Braun & Aesculap. 2006. Suture Glossary.http://www.themonofilamentadvantage.com/documents/Training/Glossary_Sutures _neu.pdf 3. Chrimax. 2001. Non-absrobable Materials: Reaction in Tissue. http://www.chirmax.cz/chirmax_multi/index.php?stranka_id=21&jazyk=3j 4. Dunn, D.L. 2007. Wound Closure Manual. Johnson & Johnson. http://surgery.uthscsa.edu/pediatric/training/woundclosuremanual.pdf 5. Engineering Toolbox. 2012. Stiffness. http://www.engineeringtoolbox.com/stiffness- d_1396.html 6. Helmenstine, A.M. 2012. Strain. About.com Chemistry. http://chemistry.about.com/od/engineeringglossary/g/strain-definition.htm 7. Najibi, S., Banglmeier, R., Matta, J.M. & Tannast, M. 2001. Material Properties of Common Suture Materials in Orthopaedic Surgery. The Iowa Orthopaedic Journal 30:84-88. 8. Postlethwait, R.W., Willigan, D.A. & Ulin, A.W. 1975. Human Tissue Reaction to Sutures. Annals of Surgery 181(2):144-150 9. Ratner, B.D., Hoffman, A.S., Schoen, F.J. & Lemons, J.E. 2004. Surface Properties and Surface Characterization of Materials. Biomaterial Science: An Introduction to Material in Medicine. 2nd Edition. San Diego: Elsevier 10. Salhan, S & Dass, A. 2012. Textbook of Gynecology. New Delhi: Jaypee Brothers Medical. 11. US Pharmacopeia. http://www.pharmacopeia.cn/v29240/usp29nf24s0_m80190.html