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WO1999027014A1 - Pansement a base d'hydrocolloide et procede de fabrication et d'utilisation dudit pansement - Google Patents

Pansement a base d'hydrocolloide et procede de fabrication et d'utilisation dudit pansement Download PDF

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Publication number
WO1999027014A1
WO1999027014A1 PCT/IB1998/001997 IB9801997W WO9927014A1 WO 1999027014 A1 WO1999027014 A1 WO 1999027014A1 IB 9801997 W IB9801997 W IB 9801997W WO 9927014 A1 WO9927014 A1 WO 9927014A1
Authority
WO
WIPO (PCT)
Prior art keywords
hydrocolloid
group
composition
dressing
styrene
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB1998/001997
Other languages
English (en)
Inventor
Roger Lipman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien AG
Original Assignee
Sherwood Service AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sherwood Service AG filed Critical Sherwood Service AG
Priority to AU13477/99A priority Critical patent/AU1347799A/en
Publication of WO1999027014A1 publication Critical patent/WO1999027014A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052—Mixtures of macromolecular compounds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
    • C08L1/08—Cellulose derivatives
    • C08L1/26—Cellulose ethers
    • C08L1/28—Alkyl ethers
    • C08L1/286—Alkyl ethers substituted with acid radicals, e.g. carboxymethyl cellulose [CMC]
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/06—Pectin; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • C08L89/04—Products derived from waste materials, e.g. horn, hoof or hair
    • C08L89/06—Products derived from waste materials, e.g. horn, hoof or hair derived from leather or skin, e.g. gelatin

Definitions

  • the present invention relates to a hydrocolloid wound dressing and a method of making and using the same. More particularly, the present invention relates to a flexible, adhesive, hydrocolloid wound dressing which is highly absorptive, adheres to a wound site, contours to a wound site and maintains the wound in a moist state to promote healing thereof and the method of producing and using the same.
  • wound exudate absorption dressings are manufactured comprised of hydrocolloid materials.
  • a wound dressing includes the Ultec TM hydrocolloid dressing manufactured by Sherwood Medical Company, St. Louis,
  • the Ultec hydrocolloid wound dressing is a wound dressing capable of absorbing wound exudate. Disadvantages noted in manufacturing and using the Ultec hydrocolloid wound dressing include limited strength and integrity of the dressing. Upon stretching the hydrocolloid material used in the dressing and upon removal thereof from a wound following use, the hydrocolloid material if used alone tends to tear and become incapable of being removed in a unitary fashion. This limited strength and integrity of the overall hydrocolloid material therefor requires, during the manufacturing thereof, the addition of a foam backing support portion to be applied thereto.
  • Another hydrocolloid wound dressing currently marketed for use with draining wounds is the Duoderm TM hydrocolloid wound dressing manufactured by Convatec, Incorporated, Skillman, New
  • the Duoderm TM hydrocolloid wound dressing is not an ideal product as it is relatively expensive to manufacture due to the use of cross-linked carboxymethyl cellulose as a rheological agent within the dressing. Accordingly, the need exists for a relatively low cost sterile wound dressing which provides a size appropriate protective adhesive covering for a draining wound capable of absorbing exudate from the wound. It is also desirable to have a wound dressing suitable to seal and protect a wound from debris and foreign matter capable of contaminating and/or infecting the wound. It is also desirable to have a wound dressing which is economical to produce. It is also desirable to have a wound dressing which does not adhere to the new tissue forming in the wound. It is also desirable to have a wound dressing with the necessary strength and integrity to be stretched or removed in a unitary fashion from a wound following use without requiring an additional foam backing support portion to be added to the construction thereof.
  • the present invention relates to an adhesive hydrocolloid wound dressing capable of absorbing exudate from a draining wound without becoming adhered to the wound while fully adhering to the skin surrounding the wound.
  • the wound dressing of the present invention interacts with wound exudate to form a soft gel that provides continued absorbent action while maintaining the wound in a slightly moist state to promote healing of the wound.
  • the subject hydrocolloid wound dressing likewise retains its overall strength after wound contact and interaction with wound exudate to allow for removal thereof in a unitary fashion.
  • the hydrocolloid wound dressing of the present invention is a hydrocolloid adhesive material preferably comprising polyisobutylene, hydrocolloid powders, fumed silica, rubber, styrene copolymer, tackifier, mineral oil and optionally one or more stabilizers and an antimicrobial and/or a bacteriostatic agent .
  • the method of producing the hydrocolloid material of the present invention involves a specific blended formulation of the above-noted components to produce a continuous matrix of viscous hydrocarbon polymer with a hydrocolloid powder dispersed throughout as described in more detail below.
  • the resultant hydrocolloid adhesive material is blended and then extruded between a polyurethane backing sheet and a siliconized release paper.
  • the subject hydrocolloid adhesive is then die-cut, packaged and sterilized using radiation sterilization, or any other suitable sterilization technique known in the art, to produce a desirable wound dressing for commercial distribution.
  • the adhesive hydrocolloid wound dressing of the present invention is capable of absorbing moisture from a wound site until the overall composition comprises approximately 40 to 50 percent fluid.
  • the subject adhesive hydrocolloid wound dressing provides for moist wound healing, adheres to tissue surrounding a wound but does not adhere to the wound site, absorbs wound exudate, allows for fewer dressing changes, allows for easy removal with no trauma to the wound, protects the wound from contamination and minimizes odor.
  • the hydrocolloid material of the present invention is generally produced by blending a low molecular weight, i.e., 1,000 to 25,000 molecular weight but more preferably 10,000 to 14,000 molecular weight polyisobutylene, such as but not limited to Vistanex TM LMMH produced by Exxon Corporation, Irving, Texas, with one or more hydrocolloid powders such as but not limited to sodium carboxymethyl cellulose, gelatine, pectin and karaya gum but preferably a blend of equal amounts of sodium carboxymethyl cellulose, gelatine and pectin for more even blending, fumed silica, one or more block copolymer rubbers such as but not limited to styrene- isoprene copolymer, styrene-isoprene-styrene copolymer and styrene-butadiene copolymer, but preferably styrene- isoprene-styrene copolymer for improved ab
  • polymer stabilizers such as but not limited to anti-oxidants that are polyphenols or hindered phenols such as t-butyl substituted phenols examples of which are Irganox TM 565 and Irganox TM 1010 produced by Ciba-Geigy of Switzerland, or organophosphites and more particularly Cl-15 alkylated aryl phosphites such as tris (nonylphenyl) phosphate an example of which is Polygard TM HR manufactured by Uniroyal, Sarasota, Florida, or a combination of anti-oxidants and organophosphites, and optionally one or more antimicrobial and/or bacteriostatic agents.
  • polymer stabilizers such as but not limited to anti-oxidants that are polyphenols or hindered phenols such as t-butyl substituted phenols examples of which are Irganox TM 565 and Irganox TM 1010 produced by Ciba-Geigy of Switzerland
  • Suitable antimicrobial agents include silver sulfadiazine, idoxuridine, trifluorouddine, vidarabine and pyrimethamine , but most preferably silver sulfadiazine due to its proven effectiveness.
  • Suitable bacteriostatic agents include bismuth tribromophenate, bacitracin, and erythromycin, but most preferably bismuth tribromophenate due to its proven effectiveness.
  • Stabilizer, mineral oil, and tactifying resin were weighed and blended into a melted styrene- isoprene-styrene (SIS) block copolymer in a Z- blade mixer at 150°C, to make an intermediate composition similar to a hot-melt adhesive composition referred to herein as a premix.
  • This premix composition was then poured off into release coated moulds and allowed to cool.
  • the cooled premix composition was then further blended into the desired adhesive at a final processing temperature of 100°C.
  • the lower temperature of 100°C is suitable for processing the present hydrocolloid powders, which would decompose and darken unacceptably at a higher temperature of 150°C.
  • the heaters were activated and allowed to heat up again to 100°C.
  • the polyisobutylene was weighed on clean double sided release paper, using a knife lubricated with pharmacopeia grade isopropanol to facilitate cutting the material as it flowed out of its container. If necessary, the polyisobutylene may likewise be wrapped for storage in the double sided paper.
  • the butyl rubber was also weighed and kept on release paper, namely, Steralease TM 19 release paper manufactured by Sterling Chemicals, Houston, Texas, until required.
  • the three hydrocolloid powders, gelatine, pectin and sodium carboxymethyl cellulose were weighed into clean, tared plastic bags. The fumed silica was then weighed and placed into the plastic bags containing the gelatine.
  • the butyl rubber was placed in the heated mixer, together with the powdery materials.
  • the mixer blades were switched on.
  • the butyl rubber was reduced to a sticky crumb by shearing in the mixer for 10 minutes.
  • the butyl rubber generated shear by combining with the powders to make the butyl rubber more tacky.
  • the mixer blades were stopped and the contents were scraped off the blades and mixed for a further 10 minutes.
  • the mixer was again stopped, the contents scraped off the blades and mixing continued for a third 10 minute period.
  • the butyl rubber must be completely dispersed into the powders . No butyl rubber crumb should be visible. If white crumb is visible, scrape down the blades and mix for a further 10 minutes, noting this additional mixing time.
  • the resulting blend is light tan or olive in colour.
  • the mixer was stopped and the premix composition together with the polyisobutylene were added. A timer and the mixer were started simultaneously and mixing was continued for 1 minute. At this stage, the mix appeared to be of a fluffy, fibrous texture.
  • the lid of the mixer was at this point opened, with the protective grille in place. The open lid allowed the moisture given off by the mix to evaporate. (All the hydrocolloid powders contain significant amounts of moisture [up to 10%wt] ) .
  • Mixing was continued for a further 29 minutes.
  • the mixer was stopped and a small sample (5g) was removed from the mixer. The small sample was pressed out between two sheets of silicone release paper in a platen press held at 85°C. The pressed sample was examined visually to check for homogeneous blending.
  • the mixer was discharged and the hydrocolloid blend placed into a holding oven at 60°C. until used.
  • composition of the hydrocolloid formulation with bacteriostatic agent of the present invention is the same as that identified in Example 1, Part A above with the addition of 3 to 7 weight percent but preferably approximately 5 weight percent for proven effectiveness of a suitable bacteriostatic agent.
  • the method of making the hydrocolloid formulation with bacteriostatic agent of the present invention is the same as that described in Example 1, Part B above with the exception of adding 3 to 7 weight percent but preferably approximately 5 weight percent of suitable bacteriostatic agent prior to the final 29 minute mix.
  • Example 3 A. Composition of Hydrocolloid Formulation With Antimicrobial Agent :
  • composition of the hydrocolloid formulation with bacteriostatic agent of the present invention is the same as that identified in Example 1, Part A above, with the addition of 1 to 5 weight percent but preferably approximately 2 weight percent for proven effectiveness of a suitable antimicrobial agent.
  • the method of making the hydrocolloid formulation with antimicrobial agent of the present invention is the same as that described in Example 1, Part B above, with the exception of adding 1 to 5 weight percent but preferably approximately 2 weight percent of a suitable antimicrobial agent prior to the final 29 minute mix.
  • hydrocolloid composition can be converted into finished dressings by any one of a number of ways known in the art .
  • One such suitable method of converting the hydrocolloid into a finished dressing includes for example, extruding the hydrocolloid into a continuous web onto silicone release paper, and laminating a suitable film, for example polyurethane film, to the top surface thereof.
  • the complete laminate may then be die cut, packaged and sterilized with, for example, gamma radiation.
  • the hydrocolloid material is converted into finished dressings as noted above in any size or shape but is preferably cut into ropes having a length ranging from about two to twelve inches but preferably between four to eight inches for greater manageability and a width ranging from 0.1 to 2 inches but preferably about 0.25 to 0.75 inches for greater manageability or into disks having a diameter ranging between one and twelve inches but most preferably between two and six inches for ease of use.
  • the thickness of the disks and ropes may vary substantially from .01 to 1 inch in thickness but most preferably are molded to .1 inch to .5 inch in thickness for ease of use with acceptable absorption.
  • the unexpected significant advantages of the present hydrocolloid wound dressing achieved through the particular formulation of components noted above include increased absorption capabilities and increased strength and integrity.
  • the increased strength and integrity of the subject hydrocolloid material eliminates the need for backing material as described in the prior art . Additionally, the hydrocolloid material is stable, does not become brittle or crack over time, and has an extended shelf-life over other wound dressing materials and is relatively inexpensive to manufacture.
  • the subject adhesive hydrocolloid wound dressing so produced is a tan opaque color unless altered by additives such as bacteriostatic agents and the like.
  • the hydrocolloid material is blended, extruded, and die-cut, the material is packaged to undergo an appropriate sterilization technique or may be sterilized and then packaged using aseptic technique.
  • Appropriate methods of sterilization are known to those skilled in the art and include gamma radiation, electronic beam, ethylene oxide and like methods.
  • the subject hydrocolloid wound dressing is packaged and then sterilized using gamma radiation by cobalt 60 with 1 to 3 mrads but preferably 2 mrads in two independent exposure cycles.
  • Appropriate packaging for the subject hydrogel wound dressing includes metallic foil pouches such as aluminum foil pouches, polyethylene film, ethylene vinyl acetate film, polypropylene film, polyvinyl chloride film, and like packages known to those skilled in the art but preferably an ethylene vinyl acetate film liner with an aluminum foil pouch as an outer package to prevent absorption of atmospheric moisture.
  • the method of using the subject hydrocolloid wound dressing includes removing the dressing from its packaging and release paper and placing the dressing on or in the wound. The subject dressing will adhere to tissue surrounding a wound to seal the same while not adhering to the wound site. Depending on the amount of exudate draining from the wound site, the dressing should be changed approximately every 5 to 7 days.
  • the dressing in rope form can also be used for deep tunnel wounds .
  • the dressing may be cut using aseptic technique to a size appropriate for a particular wound before placing the dressing on the wound.
  • the present hydrocolloid wound dressing provides an effective moist wound dressing to maintain draining wounds in a clean protected state.
  • the wound dressing and method of making and using the same disclosed herein has specific advantages over the heretofore known means of treating draining wounds.
  • the subject wound dressing eliminates risks generally associated with the treatment of draining wounds, lessens tissue damage upon removal thereof and may be cut to the appropriate size for ease of placement and use. Hence, for these reasons as well as others, some of which hereinabove set forth, it is seen that the present hydrocolloid wound dressing represents a significant advancement in the art which has substantial commercial significance.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

Pansement adhésif à base d'hydrocolloïde qui est fortement absorbant, épouse la forme de la plaie et maintient ladite plaie dans un état d'humidité qui en favorise la cicatrisation.
PCT/IB1998/001997 1997-11-24 1998-11-20 Pansement a base d'hydrocolloide et procede de fabrication et d'utilisation dudit pansement Ceased WO1999027014A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU13477/99A AU1347799A (en) 1997-11-24 1998-11-20 Hydrocolloid wound dressing and the method of making and using the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6694597P 1997-11-24 1997-11-24
US60/066,945 1997-11-24

Publications (1)

Publication Number Publication Date
WO1999027014A1 true WO1999027014A1 (fr) 1999-06-03

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PCT/IB1998/001997 Ceased WO1999027014A1 (fr) 1997-11-24 1998-11-20 Pansement a base d'hydrocolloide et procede de fabrication et d'utilisation dudit pansement

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AU (1) AU1347799A (fr)
WO (1) WO1999027014A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001030406A1 (fr) * 1999-10-14 2001-05-03 Avery Dennison Corporation Compositions hydrocolloidales adhesives absorbant les fluides
WO2008046541A3 (fr) * 2006-10-19 2009-05-07 Beiersdorf Ag Composition de gel filmogène pour soigner la peau ou une blessure
FR2936159A1 (fr) * 2008-09-24 2010-03-26 Plasto Interface chirurgicale pour plaie, avec support
FR2936158A1 (fr) * 2008-09-24 2010-03-26 Plasto Interface chirurgicale pour plaie, sans support
FR2942234A1 (fr) * 2009-02-17 2010-08-20 Univ Picardie Procede d'obtention d'un agro materiau, notamment agro liant ou agro composite, et agro materiau obtenu par un tel procede
JP4712380B2 (ja) * 2002-07-26 2011-06-29 三笠製薬株式会社 外用剤
WO2011135255A1 (fr) * 2010-04-28 2011-11-03 Laboratoires Urgo Pansement ampoule comprenant au moins deux resines tackifiantes
WO2011135256A1 (fr) * 2010-04-28 2011-11-03 Laboratoires Urgo Pansement ampoule comprenant une masse adhesive hydrocolloide
CN108384510A (zh) * 2017-02-03 2018-08-10 贝朗医疗公司 粘合剂组合物以及用于附着人皮肤的元件
US10709807B2 (en) 2014-10-01 2020-07-14 3M Innovative Properties Company Porous devices, kits, and methods for debridement
CN116999613A (zh) * 2023-08-08 2023-11-07 江西3L医用制品集团股份有限公司 一种连续式生产医用水胶体敷料的制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0130061A1 (fr) * 1983-06-27 1985-01-02 E.R. Squibb & Sons, Inc. Composition adhésive résistant aux fluides biologiques
US4496357A (en) * 1981-06-10 1985-01-29 Hollister Incorporated Skin barrier composition
US5466724A (en) * 1993-06-01 1995-11-14 Variseal Corporation Adhesive composition for a wound dressing
US5492943A (en) * 1994-06-20 1996-02-20 Hollister Incorporated Adhesive skin barrier composition for ostomy appliance

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4496357A (en) * 1981-06-10 1985-01-29 Hollister Incorporated Skin barrier composition
EP0130061A1 (fr) * 1983-06-27 1985-01-02 E.R. Squibb & Sons, Inc. Composition adhésive résistant aux fluides biologiques
US5466724A (en) * 1993-06-01 1995-11-14 Variseal Corporation Adhesive composition for a wound dressing
US5492943A (en) * 1994-06-20 1996-02-20 Hollister Incorporated Adhesive skin barrier composition for ostomy appliance

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU772824B2 (en) * 1999-10-14 2004-05-06 Avery Dennison Corporation Fluid absorbing, adhesive hydrocolloid compositions
WO2001030406A1 (fr) * 1999-10-14 2001-05-03 Avery Dennison Corporation Compositions hydrocolloidales adhesives absorbant les fluides
JP4712380B2 (ja) * 2002-07-26 2011-06-29 三笠製薬株式会社 外用剤
WO2008046541A3 (fr) * 2006-10-19 2009-05-07 Beiersdorf Ag Composition de gel filmogène pour soigner la peau ou une blessure
CN101594891A (zh) * 2006-10-19 2009-12-02 拜尔斯道夫股份公司 用于创伤护理或皮肤护理的成膜凝胶合成物
FR2936159A1 (fr) * 2008-09-24 2010-03-26 Plasto Interface chirurgicale pour plaie, avec support
EP2168607A1 (fr) * 2008-09-24 2010-03-31 Plasto Interface chirurgicale pour plaie, sans support
FR2936158A1 (fr) * 2008-09-24 2010-03-26 Plasto Interface chirurgicale pour plaie, sans support
FR2942234A1 (fr) * 2009-02-17 2010-08-20 Univ Picardie Procede d'obtention d'un agro materiau, notamment agro liant ou agro composite, et agro materiau obtenu par un tel procede
WO2011135255A1 (fr) * 2010-04-28 2011-11-03 Laboratoires Urgo Pansement ampoule comprenant au moins deux resines tackifiantes
WO2011135256A1 (fr) * 2010-04-28 2011-11-03 Laboratoires Urgo Pansement ampoule comprenant une masse adhesive hydrocolloide
FR2959417A1 (fr) * 2010-04-28 2011-11-04 Urgo Lab Pansement ampoule comprenant au moins deux resines tackifiantes
FR2959418A1 (fr) * 2010-04-28 2011-11-04 Urgo Lab Pansement ampoule comprenant une masse adhesive hydrocolloide
US10709807B2 (en) 2014-10-01 2020-07-14 3M Innovative Properties Company Porous devices, kits, and methods for debridement
CN108384510A (zh) * 2017-02-03 2018-08-10 贝朗医疗公司 粘合剂组合物以及用于附着人皮肤的元件
CN108384510B (zh) * 2017-02-03 2021-11-30 贝朗医疗公司 粘合剂组合物以及用于附着人皮肤的元件
CN116999613A (zh) * 2023-08-08 2023-11-07 江西3L医用制品集团股份有限公司 一种连续式生产医用水胶体敷料的制备方法

Also Published As

Publication number Publication date
AU1347799A (en) 1999-06-15

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