WO1999027014A1

WO1999027014A1 - Hydrocolloid wound dressing and the method of making and using the same

Info

Publication number: WO1999027014A1
Application number: PCT/IB1998/001997
Authority: WO
Inventors: Roger Lipman
Original assignee: Sherwood Service AG
Current assignee: Covidien AG
Priority date: 1997-11-24
Filing date: 1998-11-20
Publication date: 1999-06-03
Anticipated expiration: 2000-05-24
Also published as: AU1347799A

Abstract

An adhesive hydrocolloid wound dressing which is highly absorptive, contours to a wound site and maintains the wound in a moist state to promote healing thereof.

Description

HYDROCOLLOID WOUND DRESSING AND THE METHOD OF MAKING AND USING THE SAME

Field of the Invention

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.

Background of the Invention

The treatment of draining wounds is a problem in the medical profession. Wound exudate such as blood, serum and purulent matter from a draining wound can lead to bacterial growth and delayed healing if not treated properly. Often times it is difficult to maintain wounds free of such wound secretions to allow for healing. A concern in treating draining wounds is proper protection of the wound from bacterial contamination and infection. Another concern in treating such draining wounds is over drying since some believe that allowing a wound to heal in a slightly moist state may actually accelerate healing. Accordingly, the medical profession desires a means for forming and maintaining a seal over draining wounds to maintain the wound in a clean, moist protected state during healing. Currently in an attempt to meet such wound treatment needs, wound exudate absorption dressings are manufactured comprised of hydrocolloid materials. One example of such a wound dressing includes the Ultec^™ hydrocolloid dressing manufactured by Sherwood Medical Company, St. Louis,

Missouri. 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^™ hydrocolloid wound dressing manufactured by Convatec, Incorporated, Skillman, New

Jersey. The Duoderm^™ 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.

Summary of the Invention

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.

Detailed Description of the Invention 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^™ 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 absorption, one or more higher molecular weight, i.e., 20,000 to 60,000 molecular weight but more preferably 25,000 to 50,000 molecular weight rubbers such as but not limited to butyl rubber and polyisobutylene rubber, but preferably butyl rubber for improved strength, mineral oil, tackifying resin such as but not limited to rosin esters and more particularly esters derived from tall oil, an example of which is Bevilite^™ 62-107 manufactured by Bergvik of Sweden, or C₅ hydrocarbon resins derived from pentene or pentadiene, an example of which is Wingtak^™ Extra manufactured by B. F. Goodrich, Richfield, Ohio, or a combination of rosin esters and C₅ hydrocarbon resins, optionally one or more 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^™ 565 and Irganox^™ 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^™ HR manufactured by Uniroyal, Sarasota, Florida, or a combination of anti-oxidants and organophosphites, and optionally one or more antimicrobial and/or bacteriostatic agents. 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. The method of making the hydrocolloid wound dressing of the present invention is further described in the following examples.

EXAMPLE 1:

A. Composition of Hydrocolloid Formulation:

* Manufactured by Exxon Corporation, Irving, Texas.

** Manufactured by Hercules, Incorporated, Wilmington, Delaware.

*** Manufactured by Degussa of Germany. thod of Making Hydrocolloid Composition:

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.

After cleaning the 50 gallon Z-blade mixer, 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^™ 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. At the end of this time, 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.

Example 2 :

A. Composition of Hydrocolloid Formulation With Bacteriostatic Agent:

The 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. B. Method of Making Hydrocolloid Formulation With 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 :

The 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.

B. Method of Making Hydrocolloid Formulation With 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.

The above-described 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.

Once the hydrocolloid material is blended as described in detail in the above Examples, 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. After 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. Preferably, 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.

It is seen therefore that 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.

While there is shown and described herein certain specific embodiments of the invention, it will be manifest to those skilled in the art that various modifications may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A hydrocolloid composition comprising a styrene-based block copolymer, polyisobutylene, one or more hydrocolloid powders, fumed silica, rubber, tackifier resin, stabilizer and mineral oil .

2. The composition of claim 1 wherein said styrene-based block copolymer is selected from the group consisting of styrene-isoprene copolymer, styrene-isoprene-styrene copolymer and styrene-butadiene copolymer.

3. The composition of claim 1 wherein said styrene-based block copolymer is styrene-isoprene-styrene copolymer.

4. The composition of claim 1 wherein said one or more hydrocolloid powders are selected from the group consisting of pectin, sodium carboxymethyl cellulose, gelatine and karaya gum.

5. The composition of claim 1 wherein said one or more hydrocolloid powders include pectin, sodium carboxymethyl cellulose and gelatine.

6. The composition of claim 1 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 20,000 to 60,000.

7. The composition of claim 1 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 25,000 to 50,000.

8. The composition of claim 1 wherein said rubber is selected from the group consisting of butyl rubber and polyisobutylene rubber.

9. The composition of claim 1 wherein said rubber is butyl rubber.

10. The composition of claim 1 wherein said tackifier resin is selected from the group consisting of rosin esters, hydrocarbon resins and rosin ester and hydrocarbon resin combinations.

11. The composition of claim 1 wherein said tackifier resin is selected from the group consisting of esters derived from tall oil, resins derived from pentene or pentadiene and such ester and resin combinations.

12. The composition of claim 1 wherein said stabilizer is selected from the group consisting of anti-oxidants, organophosphites and combinations of anti-oxidants and organophosphites.

13. The composition of claim 1 wherein said stabilizer is selected from the group consisting of polyphenols, hindered phenols, alkylated aryl phosphites, and combinations of polyphenols or hindered phenols and alkylated aryl phosphites .

14. The composition of claim 1 wherein said stabilizer is selected from the group consisting of t-butyl substituted phenols, tris (nonylphenyl) phosphate and a combination of t- butyl substituted phenols and tris (nonylphenyl) phosphate.

15. The composition of claim 1 wherein a bacteriostatic agent is added to reduce wound odor and risk of infection when used as a wound dressing.

16. The composition of claim 1 wherein a bacteriostatic agent selected from the group consisting of bismuth tribromophenate, bacitracin and erythromycin is added to reduce wound odor and risk of infection when used as a wound dressing.

17. The composition of claim 1 wherein bismuth tribromophenate is added to reduce wound odor and risk of infection when used as a wound dressing.

18. The composition of claim 1 wherein an antimicrobial agent is added to reduce wound odor and risk of infection when used as a wound dressing.

19. The composition of claim 1 wherein an antimicrobial agent selected from the group consisting of silver sulfadiazine, idoxuridine, trifluorouddine, vidarabine and pyrimethamine is added to reduce wound odor and risk of infection when used as a wound dressing.

20. The composition of claim 1 wherein silver sulfadiazine is added to reduce wound odor and risk of infection when used as a wound dressing.

21. The composition of claim 1 wherein said composition is formed in the shape of a disc or rope approximately 0. 01 to 1.00 inch in thickness.

22. The composition of claim 1 wherein said composition is formed in the shape of a disc with a diameter ranging from approximately 1. 0 inches to 12.0 inches.

23. The composition of claim 1 wherein said composition is formed in the shape of a rope with length ranging from approximately 2 inches to 12 inches and width from 0. 10 to 2.00 inches.

24. The composition of claim 1 wherein said composition is capable of absorbing approximately 40 to 50 weight percent moisture.

25. A hydrocolloid wound dressing comprising a styrene- based block copolymer, polyisobutylene, hydrocolloid powders, fumed silica, rubber, tackifier resin, stabilizer and mineral oil.

26. The dressing of claim 25 wherein said styrene-based block copolymer is selected from the group consisting of styrene-isoprene copolymer, styrene-isoprene-styrene copolymer and styrene-butadiene copolymer.

27. The dressing of claim 25 wherein said styrene-based block copolymer is styrene-isoprene-styrene copolymer.

28. The dressing of claim 25 wherein said one or more hydrocolloid powders are selected from the group consisting of pectin, sodium carboxymethyl cellulose, gelatine and karaya gum.

29. The dressing of claim 25 wherein said one or more hydrocolloid powders include pectin, sodium carboxymethyl cellulose and gelatine.

30. The dressing of claim 25 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 20,000 to 60,000.

31. The dressing of claim 25 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 25,000 to 50,000.

32. The dressing of claim 25 wherein said rubber is selected from the group consisting of butyl rubber and polyisobutylene rubber.

33. The dressing of claim 25 wherein said rubber is butyl rubber.

34. The dressing of claim 25 wherein said tackifier resin is selected from the group consisting of rosin esters, hydrocarbon resins and rosin ester and hydrocarbon resin combinations .

35. The dressing of claim 25 wherein said tackifier resin is selected from the group consisting of esters derived from tall oil, resins derived from pentene or pentadiene and such ester and resin combinations.

36. The dressing of claim 25 wherein said stabilizer is selected from the group consisting of anti-oxidants, organophosphites and combinations of anti-oxidants and organophosphites .

37. The dressing of claim 25 wherein said stabilizer is selected from the group consisting of polyphenols, hindered phenols, alkylated aryl phosphites, and combinations of polyphenols or hindered phenols and alkylated aryl phosphites.

38. The dressing of claim 25 wherein said stabilizer is selected from the group consisting of t-butyl substituted phenols, tris (nonylphenyl) phosphate and a combination of t- butyl substituted phenols and tris (nonylphenyl) phosphate.

39. The dressing of claim 25 wherein a bacteriostatic agent is added to reduce wound odor and risk of infection.

40. The dressing of claim 25 wherein a bacteriostatic agent selected from the group consisting of bismuth tribromophenate, bacitracin and erythromycin is added to reduce wound odor and risk of infection.

41. The dressing of claim 25 wherein bismuth tribromophenate is added to reduce wound odor and risk of infection.

42. The dressing of claim 25 wherein an antimicrobial agent is added to reduce wound odor and risk of infection.

43. The dressing of claim 25 wherein an antimicrobial agent selected from the group consisting of silver sulfadiazine, idoxuridine, trifluorouddine, vidarabine and pyrimethamine is added to reduce wound odor and risk of infection.

44. The dressing of claim 25 wherein silver sulfadiazine is added to reduce wound odor and risk of infection.

45. The dressing of claim 25 wherein said wound dressing is formed in the shape of a disc or rope approximately 0. 01 to 1.00 inch in thickness.

46. The dressing of claim 25 wherein said wound dressing is formed in the shape of a disc with a diameter ranging from approximately 1. 0 inches to 12.0 inches .

47. The dressing of claim 25 wherein said wound dressing is formed in the shape of a rope with length ranging from approximately 2 inches to 12 inches and width from 0. 10 to 2.00 inches.

48. The dressing of claim 25 wherein said wound dressing is capable of absorbing approximately 40 to 50 weight percent moisture.

49. A method of producing a hydrocolloid composition comprising: blending styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica and rubber.

50. The method of claim 49 wherein said styrene-based block copolymer is selected from the group consisting of styrene-isoprene copolymer, styrene-isoprene-styrene copolymer and styrene-butadiene copolymer.

51. The method of claim 49 wherein said styrene-based block copolymer is styrene-isoprene-styrene copolymer.

52. The method of claim 49 wherein said one or more hydrocolloid powders are selected from the group consisting of pectin, sodium carboxymethyl cellulose, gelatine and karaya gum.

53. The method of claim 49 wherein said one or more hydrocolloid powders include pectin, sodium carboxymethyl cellulose and gelatine.

54. The method of claim 49 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 20,000 to 60,000.

55. The method of claim 49 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 25,000 to 50,000.

56. The method of claim 49 wherein said rubber is selected from the group consisting of butyl rubber and polyisobutylene rubber.

57. The method of claim 49 wherein said rubber is butyl rubber.

58. The method of claim 49 wherein said tackifier resin is selected from the group consisting of rosin esters, hydrocarbon resins and rosin ester and hydrocarbon resin combinations.

59. The method of claim 49 wherein said tackifier resin is selected from the group consisting of esters derived from tall oil, resins derived from pentene or pentadiene and such ester and resin combinations.

60. The method of claim 49 wherein said stabilizer is selected from the group consisting of anti-oxidants, organophosphites and combinations of anti-oxidants and organophosphites .

61. The method of claim 49 wherein said stabilizer is selected from the group consisting of polyphenols, hindered phenols, alkylated aryl phosphites, and combinations of polyphenols or hindered phenols and alkylated aryl phosphites .

62. The method of claim 49 wherein said stabilizer is selected from the group consisting of t-butyl substituted phenols, tris (nonylphenyl) phosphate and a combination of t- butyl substituted phenols and tris (nonylphenyl) phosphate.

63. A method of producing a hydrocolloid composition comprising: blending a styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica, rubber and a bacteriostatic agent.

64. The method of claim 63 wherein said bacteriostatic agent is selected from the group consisting of bismuth tribromophenate, bacitracin and erythromycin.

65. The method of claim 63 wherein said bacteriostatic agent is bismuth tribromophenate.

66. The method of claim 63 wherein said bacteriostatic agent is approximately 5 percent by weight bismuth tribromophenate .

67. A method of producing a hydrocolloid composition comprising: blending a styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica, rubber and an antimicrobial agent.

68. The method of claim 67 wherein said antimicrobial agent is selected from the group consisting of silver sulfadiazine, idoxuridine, trifluorouddine, vidarabine and pyrimethamine .

69. The method of claim 67 wherein said antimicrobial agent is silver sulfadiazine.

70. The method of claim 67 wherein said antimicrobial agent is approximately 2 percent by weight silver sulfadiazine.

71. A method of using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 for use as a wound dressing comprising sterilizing said hydrocolloid composition and placing said hydrocolloid composition on or in a wound.

72. A method of using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 for use as a wound dressing comprising extruding and sterilizing said hydrocolloid composition and placing said hydrocolloid composition on or in a wound.

73. A method of using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 for use as a wound dressing comprising extruding, die cutting and sterilizing said hydrocolloid composition and placing said hydrocolloid composition on or in a wound.

74. A method of using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 for use as a wound dressing comprising extruding, die cutting, packaging and sterilizing said hydrocolloid composition for storage prior to removing said packaging and placing said hydrocolloid composition on or in a wound.

75. The method of claim 49, 63 or 67 wherein said hydrocolloid composition is extruded and die-cut to form a dressing approximately 0. 01 inch 1.0 inch thick.

76. The method of claim 49, 63 or 67 wherein said hydrocolloid composition is extruded and die-cut to form a dressing in the shape of a disc with a diameter ranging from approximately 1. 0 inches to 12.0 inches .

77. The method of claim 49, 63 or 67 wherein said hydrocolloid composition is extruded and die-cut in the shape of a rope with approximately 2 to 12 inches in length and 0. 1 to 2.0 inches in width.

78. A method of making a wound dressing using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising sterilizing said hydrocolloid composition.

79. A method of making a wound dressing using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising extruding and sterilizing said hydrocolloid composition.

80. A method of making a wound dressing using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising extruding, die cutting and sterilizing said hydrocolloid composition.

81. A method of making a wound dressing using the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising extruding, die cutting, packaging and sterilizing said hydrocolloid composition.

82. A method of using a wound dressing formed from the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising placing said dressing on or in a draining wound.

83. A method of using a wound dressing formed from the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising placing said dressing on or in a draining wound and removing after 5 to 7 days .

84. A method of using a wound dressing formed from the hydrocolloid composition produced in accordance with claim 49, 63 or 67 comprising placing said dressing on or in a draining wound and replacing the same as medically necessary.

85. A method of producing a hydrocolloid wound dressing comprising: blending styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica and rubber.

86. The method of claim 85 wherein said styrene-based block copolymer is selected from the group consisting of styrene-isoprene copolymer, styrene-isoprene-styrene copolymer and styrene-butadiene copolymer.

87. The method of claim 85 wherein said styrene-based block copolymer is styrene-isoprene-styrene copolymer.

88. The method of claim 85 wherein said one or more hydrocolloid powders are selected from the group consisting of pectin, sodium carboxymethyl cellulose, gelatine and karaya gum.

89. The method of claim 85 wherein said one or more hydrocolloid powders include pectin, sodium carboxymethyl cellulose and gelatine.

90. The method of claim 85 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 20,000 to 60,000.

91. The method of claim 85 wherein said rubber is selected from the group consisting of rubbers having a molecular weight within the range of 25,000 to 50,000.

92. The method of claim 85 wherein said rubber is selected from the group consisting of butyl rubber and polyisobutylene rubber.

93. The method of claim 85 wherein said rubber is butyl rubber.

94. The method of claim 85 wherein said tackifier resin is selected from the group consisting of rosin esters, hydrocarbon resins and rosin ester and hydrocarbon resin combinations .

95. The method of claim 85 wherein said tackifier resin is selected from the group consisting of esters derived from tall oil, resins derived from pentene or pentadiene and such ester and resin combinations.

96. The method of claim 85 wherein said stabilizer is selected from the group consisting of anti-oxidants, organophosphites and combinations of anti-oxidants and organophosphites .

97. The method of claim 85 wherein said stabilizer is selected from the group consisting of polyphenols, hindered phenols, alkylated aryl phosphites, and combinations of polyphenols or hindered phenols and alkylated aryl phosphites .

98. The method of claim 85 wherein said stabilizer is selected from the group consisting of t-butyl substituted phenols, tris (nonylphenyl) phosphate and a combination of t- butyl substituted phenols and tris (nonylphenyl) phosphate.

99. A method of producing a hydrocolloid wound dressing comprising: blending a styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica, rubber and a bacteriostatic agent.

100. The method of claim 99 wherein said bacteriostatic agent is selected from the group consisting of bismuth tribromophenate, bacitracin and erythromycin.

101. The method of claim 99 wherein said bacteriostatic agent is bismuth tribromophenate.

102. The method of claim 99 wherein said bacteriostatic agent is approximately 5 percent by weight bismuth tribromophenate.

103. A method of producing a hydrocolloid wound dressing comprising: blending a styrene-based block copolymer, stabilizer, mineral oil and resin with polyisobutylene, one or more hydrocolloid powders, fumed silica, rubber and an antimicrobial agent .

104. The method of claim 103 wherein said antimicrobial agent is selected from the group consisting of silver sulfadiazine, idoxuridine, trifluorouddine, vidarabine and pyrimethamine .

105. The method of claim 103 wherein said antimicrobial agent is silver sulfadiazine.

106. The method of claim 103 wherein said antimicrobial agent is approximately 2 percent by weight silver sulfadiazine.