LAYERED APERTURED WOUND DRESSING, PROCESS OF MANUFACTURE AND USEFUL ARTICLES THEREOF

Abstract

This invention relates to a novel wound dressing design. Particularly, this invention relates to a wound dressing which incorporates multiple distinct layers, each providing useful features and together providing a novel method of managing a variety of wound types. Moist healing, exudate management, ease of use and patient comfort are provided. In a preferred embodiment, the new dressing comprises a thin layer of gel continuously coated onto a thin film material which is laminated to an apertured mesh. Preferably, the gel coated thin film material is fenestrated or perforated. This construction improves dressing fixation, provides a semi-occlusive wound environment while simultaneously managing copious amounts of exudate.

Claims

1. A wound dressing comprising of multiple layers, wherein a first wound contacting layer is a semi-adherent polymer, a second more distal layer is a semi-occlusive thin film membrane, and a third more distal layer is a non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh.

2. The wound dressing of claim 1, wherein the apertured mesh is a woven or knitted textile material.

3. The wound dressing of claim 1, wherein the apertured mesh is a nonwoven material.

4. The wound dressing of claim 1, wherein the apertured mesh is an extruded scrim.

5. The wound dressing of claim 1, wherein the first wound contacting layer and the second more distal layer are fenestrated.

6. The wound dressing of claim 1, further including an antimicrobial substance contained in the first layer.

7. The wound dressing of claim 1, further including an antimicrobial substance contained in the third more distal layer of non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh.

8. The wound dressing of claim 1, further including an antimicrobial substance contained in the first layer and an antimicrobial substance contained in the third more distal layer of non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh.

9. A method of manufacturing a multilayered wound dressing comprising the steps of (1) creating a thin film with a suitable wound contacting semi-adherent surface, (2) creating an at least partially impregnated apertured mesh by at least partially impregnating an apertured mesh with a polymer gel so that apertures of the at least partially impregnated apertured mesh remain open to passage of wound exudate, the apertured mesh having an outer surface that faces away from a wound application site, and (3) adhering the thin film and the at least partially impregnated apertured mesh together creating a multilayered wound dressing having a wound contacting surface and a distal surface, the wound contacting surface being the wound contacting semi-adherent surface of the thin film and the distal surface being the outer surface of the apertured mesh.

10. The method of claim 9, further including fenestrating said thin film to create openings for exudate passage.

11. A method of managing a variety of wound types, comprising the steps of providing the wound dressing of claim 5, and applying the wound dressing to a wound with the first wound contacting layer being against the wound, so that wound exudate passes through the wound dressing, while integration of the wound dressing into the wound and slippage and wrinkling of the wound dressing on the wound are limited.

12. The method of claim 11, further including providing an antimicrobial substance in the first layer of the wound dressing.

13. A method of managing a wound, comprising providing the wound dressing of claim 5, applying the wound dressing to a wound with the first wound contacting layer being against the wound, and, creating with the wound dressing on the wound a moist healing environment for the wound, while (a) limiting slippage and wrinkling of the wound dressing on the wound, (b) permitting wound exudate to pass through the wound dressing, and (c) limiting integration of the wound dressing into the wound.

14. A method of managing a wound, comprising providing the wound dressing of claim 1, applying the wound dressing to the wound with the first wound contacting layer being against the wound, and creating with the wound dressing on the wound a moist healing environment for the wound, while (a) limiting slippage and wrinkling of the wound dressing on the wound, and (b) limiting integration of the wound dressing into the wound.

15. A wound dressing, comprising a semi-adherent wound contacting polymeric membrane layer having a first side and a second side, and an apertured mesh layer, the apertured mesh layer having a first side and a second side, the first side of the apertured mesh layer having an outer surface, the apertured mesh layer comprising a material having a plurality of apertures extending therethrough from the first side of the apertured mesh layer to the second side of the apertured mesh layer, the apertured mesh layer being at least partially impregnated with silicone to coat at least a portion of the material comprising the apertured mesh layer forming a coating of silicone on at least a portion of the outer surface of the first side of the apertured mesh layer while keeping at least a portion of the apertures open to allow exudate to migrate through the apertured mesh layer, the silicone at least partially impregnating the apertured mesh layer to form a coating of silicone on at least a portion of the outer surface of the first side of the apertured mesh layer being bonded to the apertured mesh layer, and the coating of silicone on the outer surface of the first side of the apertured mesh layer being bonded to the second side of the polymeric membrane.

16. The wound dressing of claim 15, wherein the polymeric membrane layer is a semi-occlusive thin film membrane.

17. The wound dressing of claim 15, wherein the polymeric membrane layer is a silicone/PTFE IPN membrane.

18. The wound dressing of claim 15, wherein the polymeric membrane layer is a microporous resorbable polymeric membrane.

19. The wound dressing of claim 15, wherein the polymeric membrane layer is a microporous resorbable polymeric membrane comprising a copolymer of polylactic acid, polylactide, trimethylene carbonate, and e-caprolactone.

20. The wound dressing of claim 15, wherein the apertured mesh layer is a woven or knitted textile material.

21. The wound dressing of claim 15, wherein the apertured mesh layer is a non-woven material.

22. The wound dressing of claim 15, wherein the polymeric membrane layer is fenestrated.

23. A wound dressing, comprising a polymeric membrane layer having a first side and a second side, an apertured mesh layer, the apertured mesh layer having a first side and a second side, the first side of the apertured mesh layer having an outer surface, the apertured mesh layer comprising a material having a plurality of apertures extending therethrough from the first side of the apertured mesh layer to the second side of the apertured mesh layer, the apertured mesh layer being at least partially impregnated with silicone to coat at least a portion of the material comprising the apertured mesh layer forming a coating of silicone on at least a portion of the outer surface of the first side of the apertured mesh layer while keeping at least a portion of the apertures open to allow exudate to migrate through the apertured mesh layer, and a silicone gel coating the first side of the polymeric membrane layer, the silicone at least partially impregnating the apertured mesh layer to form a coating of silicone on at least a portion of the outer surface of the first side of the apertured mesh layer being bonded to the apertured mesh layer, the coating of silicone on the outer surface of the first side of the apertured mesh layer being bonded to the second side of the polymeric membrane, the silicone gel coating the first side of the polymeric membrane being bonded to the polymeric membrane, the wound dressing having a wound contacting layer, the silicone gel coating the first side of the polymeric membrane being the wound contacting layer, and the silicone gel coating the first side of the polymeric membrane layer being semi-adhesive such that the wound dressing stays in place on a wound but substantially does not permanently adhere to a wound and is substantially non-integrating with a wound.

24. The wound dressing of claim 23, wherein the polymeric membrane layer and the silicone gel coating the first side of the polymeric membrane layer are fenestrated.

25. The wound dressing of claim 23, further including an antimicrobial agent in the silicone gel coating the first side of the polymeric membrane layer.

26. The wound dressing of claim 24, further including an antimicrobial substance in the silicone gel coating the first side of the polymeric membrane layer.

27. A wound dressing comprising multiple layers, wherein a first wound contacting layer is a semi-adherent polymer film, and a second layer is a non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1a shows a cross-sectional view of a preferred embodiment of the invention. FIG. 1b shows a cross-sectional view of an alternative preferred embodiment of the invention.

[0022] FIG. 2a shows a plan view of a dressing (60) of this invention viewed from the wound contacting side, illustrating a preferred fenestration or perforation pattern.

[0023] FIGS. 2b, 2c, and 2d show plan views of the dressing (60) of this invention viewed from the wound contacting side, illustrating alternative fenestration or perforation patterns.

[0024] FIG. 3a shows a plan view of an apertured woven mesh material suitable for use for the apertured mesh layer (50) of the invention. FIG. 3b shows a plan view of an aperture mesh layer (50) partially coated with a silicone polymer (110).

[0025] FIG. 4 shows a photographic plan view of the inventive dressing (60) viewed from the side of the dressing (60) that faces towards the wound application site when the dressing (60) is applied to the wound application site.

[0026] FIG. 5a is a simplified schematic diagram of a preferred manufacturing process used to produce the IPN/gel web (280) of the invention. FIG. 5b is a simplified schematic diagram of a preferred manufacturing process used to produce the impregnated mesh web (340) (that is, apertured mesh layer (50) at least partially impregnated with silicone (40)) of this invention.

[0027] FIG. 6a is a simplified schematic diagram of a preferred manufacturing process for laminating the two webs (that is, the IPN/gel layer (15) and the impregnated mesh layer (45)) together, placing them onto a suitable release liner (260) thereby creating construction (370), and die cutting shapes (410) therefrom.

[0028] FIG. 6b is an enlarged view of a portion shown in the dashed circle A of FIG. 6a.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0029] FIG. 1 shows a cross-sectional view of a preferred embodiment of the invention. As shown in FIG. 1, the inventive dressing (60) comprises a semi-occlusive polymeric membrane layer (10)(such as a silicone/PTFE IPN membrane) that is coated with a tacky silicone gel (20) on one side, and that on its other side is bonded to the silicone coated surface (40) of an apertured mesh layer (50). The silicone gel (20) provides the wound dressing (60) with a gently adhesive wound contacting surface (30). The wound contacting surface (30) of the dressing (60) faces the wound application site and comes into contact with the wound when the dressing (60) is applied to the wound application site, and the surface (55) of the apertured mesh layer (50) faces away from the wound application site when the dressing (60) is applied to the wound application site. Due to the gently adhesive characteristic of the silicone gel (20), the wound dressing (60) easily peels off a wound when desired without the wound contacting surface (30) integrating with the wound.

[0030] FIG. 2a shows a plan view of a dressing (60) of this invention viewed from the wound contacting side, illustrating a preferred fenestration or perforation pattern. Fenestrations (70) are cut through the IPN/gel film but not through the apertured mesh. FIGS. 2b, 2c, and 2d show plan views of the dressing (60) of this invention viewed from the wound contacting side, illustrating alternative fenestration or perforation patterns. Many variations of the fenestration or perforation patterns other than those shown in FIGS. 2a, 2b, 2c and 2d are possible. It should be noted that the final shape and dimensions of the opening created by the fenestration tooling may not match precisely the dimensions of the tooling design, as tension applied to the film layer downstream from the fenestration process may affect the final geometry. For example, a slit fenestration may become an oblong oval hole if tension is applied perpendicular to the slit during later processing.

[0031] FIG. 3a shows a plan view of an apertured woven mesh material suitable for use for the aperture mesh layer (50) of the invention. Monofilaments (80) define an open aperture structure (90). FIG. 3b shows a plan view of the apertured woven mesh of FIG. 3a partially coated with silicone (110) leaving openings (95) in the apertured mesh.

[0032] FIG. 4 shows a photographic plan view of the inventive dressing (60) viewed from the side of the dressing (60) that faces towards the wound application site when the dressing (60) is applied to the wound application site, in which an apertured woven mesh (50) has been partially impregnated with silicone (110) in such a fashion as to maintain apertures (95) of the mesh (50) at least partially open, and in which the fenestration pattern (70) of the IPN/gel film (15) is present (not visible in image). The opening created by the fenestration pattern is defined by the edge of the IPG/gel film as defined by the circumscribed points 130 (slightly visible in the image). It should be noted that visualization of the IPN/gel (15) and openings defined by circumscribed points (130) is difficult due to the highly transparent nature of the INP/gel film (15). In this fashion the fenestration holes in the IPN/gel film (15) leave openings (140) penetrating entirely through the dressing. In other words, where a fenestration hole defined by circumscribed points (130) aligns with an aperture hole (95) a pathway (140) for exudate migration is created. Everywhere else is occluded by the surface (30) of the IPN/gel film 15.

[0033] FIG. 5a is a simplified schematic diagram of a preferred manufacturing process used to produce a web (280) of the IPN/gel film (15) on a polypropylene coated paper carrier substrate (150a) of the invention. A PTFE/silicone IPN (10) on carrier substrate (150a) web is unwound from a roll (160a) and passed over a roller (170). The IPN on carrier substrate (150a) passes through a reservoir of uncured liquid silicone (180a) and an adjustable blade knife (190) is set to meter off excess liquid silicone (180a) leaving behind the desired thickness of silicone gel (200a) on the IPN (10) on carrier substrate (150a). Preferably, but optionally, the uncured liquid silicone (180a) may contain an antimicrobial substance, such as 3% by weight of a non-leaching polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) or 3% by weight of silver oxysalts. The resultant construction (200a) of uncured gel (20) on IPN (10) with carrier substrate (150a) then is passed through a tunnel style oven (230) to apply heat and effectuate crosslinking of the silicone to form a web (280) of IPN/gel film (15) on carrier substrate (150a). The web (280) of IPN/gel film (15) on carrier substrate (150a) is wound onto a master roll (290).

[0034] FIG. 5b is a simplified schematic diagram of a preferred manufacturing process used to produce a web (340) of the at least partially impregnated apertured mesh material (45) (that is, a web of the apertured mesh material (50) at least partially impregnated with silicone (110) and having a silicone coated surface (40)) of this invention. A polypropylene coated paper carrier substrate (150b) is unwound from a roll (160b) and passed over a roller (170). The carrier substrate (150b) passes through a reservoir of uncured liquid silicone (180b) and an adjustable blade knife (190) is set to meter off excess liquid silicone (180b) (200b, 40) on the carrier substrate (150b). Preferably, but optionally, the uncured liquid silicone leaving behind the desired thickness of silicone gel (180b) may contain an antimicrobial substance, such as 3% by weight of a non-leaching polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) or 3% by weight of silver oxysalts. An apertured mesh (210, 50) is unwound from a roll (215) and passed over a lay down roller (220) to be put into contact with the uncured silicone (200b, 40) on the carrier substrate (150b). The resultant material then is passed through a tunnel style oven (230) to apply heat and effectuate crosslinking of the silicone to form a web (340) of at least partially impregnated apertured mesh material (45) on carrier substrate 150b, and the resultant web (340) is then taken-up onto (wound onto) a new master roll (355).

[0035] FIG. 6a is a simplified schematic diagram of a preferred manufacturing process for laminating the two webs (280) and (340) (that is, the web (280) of the IPN/gel film (15) and the web (340) of at least partially impregnated apertured mesh material (45) together, placing them onto a suitable release liner, and die cutting shapes therefrom. FIG. 6b is an enlarged view of a portion of FIG. 6a (the dashed circle labeled A. A release liner (240), such as polypropylene coated paper or polyester film, is passed through a splitting station (dashed box 250) that creates slit liner (260) having a butterfly fold, score or other suitable means (slit) of facilitating final removal and application of the finished dressing. The slit liner (260) is passed under an idler roller (270). A web (280) of IPN/gel film (15) positioned on the carrier substrate (150a) is unwound from a master roll (290) with the gel side facing the slit liner (260). The carrier substrate (150a) attached to the web (280) of the IPN/gel film (15) in the manufacturing process of FIG. 5a for making the web (280) is now removed from IPN/gel film (15) and rewound onto a roll (300) to be discarded or preferably recycled. The web (280) of IPN/gel film (15) is passed around idler roller (270) to meet the slit liner (260). Prior to the web (280) of IPN/gel film (15) passing around idler roller (270), optionally, but preferably, the web (280) of IPN/gel film (15) may be passed through a suitable cutting tool to create fenestrations (70) through the IPN/gel film (15). The optionally fenestrated web of the IPN/gel film (15) is thus put in contact with the slit release liner (260) so that the gel side contacts the slit release liner (260) and the IPN (10) side is facing away from the slit release liner. The IPN/gel film (15) on slit liner (260) (together identified in FIGS. 6a and 6b with the reference number (310)) is then passed under a second idler roller (320).

[0036] A web (340) of at least partially impregnated apertured mesh material (that is, the web (340) comprising a web (45) of apertured mesh material (50) at least partially impregnated with silicone (110) and having a silicone coated surface (40)) on carrier substrate (150b) (together identified in FIGS. 6a and 6b with the reference number (330)) is unwound from a master roll (355) with the mesh (50) side facing outwardly away from the roll (355) and the carrier substrate (150b) contacting idler roller (350). The backing carrier substrate (150b) is removed and rewound onto a roll (360) to be discarded or preferably recycled. The process of removing the carrier substrate (150b) from the silicone surface (40) creates holes (95) where the silicone is not supported by apertured matrix (50, 80). The free-standing web (335, 45) of at least partially impregnated apertured mesh material is passed under idler roller (350) and around idler roller (320) to meet web (310) (that is the IPN side (10) of IPN/gel film (15) on slit liner (260). Referring to FIG. 6b, the at least partially coated apertured mesh web material (that is, the free-standing web (335, 45) of at least partially impregnated apertured mesh material used to form the layers of the wound dressing (60) comprising the apertured mesh layer (50) at least partially impregnated with silicone (110) and having a silicone coated surface (40), and identified in FIGS. 1a and 1b with reference number (45) and in FIG. 6b additionally as 335 is passed around roller 320, and the coated side (that is, the side with the silicone coated surface (40)) of the coated apertured mesh web material is put in contact with the IPN side (10) of the IPN/gel film (15) of web (310) positioned on slit liner (260) resulting in construction (370). Preferably, a pressure applying nip roller is used at the lamination point to cause the two layers to firmly adhere together (not shown). It should be noted that in the described process holes (95) are created when the carrier substrate (150b) is removed from the web (340) of the at least partially impregnated apertured mesh material, as free-standing silicone (200b) that is not supported by the matrix (e.g., the monofilaments 80) of the apertured mesh 50 inherently adheres to carrier substrate (150b) resulting in the openings (95) in the at least partially impregnated apertured mesh (45, 335).

[0037] The constructed material (370) of layered apertured web (45) bound to the IPN side (10) of layer (15) on slit release liner (260) is then passed through a die cutting apparatus (380) to punch-cut the final wound dressing shapes. The remaining matrix not cut from web (370) (that is, the remaining material (390) left behind from the cutting process) is then rewound onto a roll (400) to be discarded or preferably recycled. The individual dressings (60) (identified in FIG. 6a with reference number (410)) resulting from these steps are then packaged and sterilized according to established methods.

[0038] Turning now to FIG. 1b, there is shown a preferred alternative embodiment of the invention. Here, the inventive would dressing (60) is substantially the same as wound dressing (60), except instead of having a semi-occlusive polymeric membrane layer such as an IPN thin film (10) coated with a silicone gel (20), wound dressing (60) is provided with a semi-occlusive polymeric membrane layer such as an IPN thin film (10) that is not coated with a silicone gel (20), since the thin film (10) has been formulated to be itself semi-adherent and therefore have a tacky gentle adhesive wound contacting surface (30). Accordingly, like the gently adhesive wound contacting surface (30) of the wound dressing (60), the tacky thin film (10) enables the wound dressing (60) to easily peel off a wound when desired without its wound contacting surface (30) integrating with the wound, and like the tacky wound contacting surface (30) of the wound dressing (60), the low tack wound contacting surface (30) of the wound dressing (60) helps the wound dressing stay in place on a wound but substantially does not permanently adhere to the wound and is substantially non-integrating with the wound. Preferably, the thin film (10) may be a silicone/PTFE IPN membrane formulated to be semi-adherent (that is, to have a gentle adhesive surface). Preferably, but optionally, the thin film (10) may be fenestrated. The wound dressing (60) may be made in the same manner as the wound dressing (60), except the application of silicone gel layer (20) may be omitted. Further, the wound dressing (60) may be used in the same manner as wound dressing (60), except rather than placing the wound contacting surface (30) of wound dressing (60) into contact with a wound as would be done with wound dressing (60), the wound contacting surface (30) of wound dressing (60) is placed into contact with a wound.

[0039] As with dressing (60), dressing (60) may be engineered to provide a desired flow rate (e.g., a low, medium or high) rate of exudate passage.

[0040] A preferred embodiment of this invention includes fenestrations through the wound contacting polymer film layer, however it is contemplated that the use of porous or microporous polymeric films may be utilized so that fenestrations or perforations are not necessary to achieve the same basic function of the present invention.

[0041] The following examples are not intended to be limiting, as variations on these designs, configurations and processes would be obvious to those skilled in the art. It is obvious that the relative layers of the dressing of this invention may be substantially varied. Example 1 shows an IPN/gel film of approximately 40 microns thickness, but at between 10 and 200 microns is sufficient. Example 1 also shows a woven mesh of 380 microns in thickness with a final partially impregnated apertured mesh of approximately 420 microns; however, these layers may range from 100 microns 600 microns in combination or independently.

[0042] Likewise, it is believed that other materials could be used to achieve the same dressing design. Throughout this specification the use of fenestrations of the polymer film layer is described as a preferred embodiment; however, microporous thin films, particularly those that resorb or dissolve also may be used regardless of being fenestrated or not.

[0043] Finally, in addition to the cut dressing shapes described herein, a useful alternative is to provide small rolls of the inventive material without a release liner for tape-like or circumferential wrap style application.

Example 1

[0044] A continuous web of polydimethylsiloxane and polytetrafluoroethylene IPN was manufactured according to established methods on a suitable carrier substrate, and then coated with a silicone gel using the equipment and process shown and described in connection with FIG. 5a. The IPN/gel film produced measured approximately 40 microns in thickness and was subsequently passed through a tool to create fenestrations substantially as shown in FIG. 2a.

[0045] A web of woven mesh approximately 380 microns thick was manufactured according to established methods, and then partially impregnated with silicone gel on a suitable carrier substrate using the equipment and process shown and described in connection with FIG. 5b resulting in a finished construction of approximately 420 microns in thickness.

[0046] Using the equipment and process shown and described in connection with FIGS. 6a and 6b, layered apertured dressings were created on a butterfly folded polypropylene coated paper release liner, cut into 1325 cm sheets, then packaged and sterilized for final use.

Example 2

[0047] Using bench-top analogs of the processes described in connection with FIGS. 5a, 5b, 6a and 6b, Example 1 was repeated, except a nonwoven mesh of approximately 325 microns in thickness was used instead of the woven mesh. The nonwoven mesh was spunlace polyester with apertures in an isotropic square pattern of 6 holes per linear cm. The finished construction measured approximately 365 microns in thickness.

Example 3

[0048] Examples 1 and 2 are repeated, except a silicone gel containing 3% by weight of a non-leaching, polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) is used. That is, the uncured liquid silicone (180a) in the reservoir shown in FIG. 5a contains 3% by weight of a non-leaching, polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride).

Example 4

[0049] Examples 1, 2 and 3 are repeated, except a silicone gel containing 3% by weight of silver oxysalts is used. That is, the uncured liquid silicone (180a) in the reservoir shown in FIG. 5a contains 3% by weight of silver oxysalts.

Example 5

[0050] Examples 1 through 4 are repeated except that a silicone gel containing 3% by weight of silver oxysalts is used. That is, the uncured liquid silicone (180b) in the reservoir shown in FIG. 5b contains 3% by weight of silver oxysalts.

Example 6

[0051] Examples 1 through 5 are repeated except a silicone gel containing 3% by weight of a non-leaching, polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) is used. That is, the uncured liquid silicone (180b) in the reservoir shown in FIG. 5b contains 3% by weight of a non-leaching, polyquat antimicrobial (3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride).

Example 7

[0052] Examples 1 through 6 are repeated, except a PTFE/silicone IPN (10) is formulated using a silicone gel so that wound contacting surface (30) is inherently tacky and except the step of coating the IPN with a silicone gel using the equipment and process shown and describe in connection with FIG. 5a is omitted.

Example 8

[0053] Example 7 are is repeated, except a microporous resorbable polymeric membrane made of a copolymer of polylactic acid, polylactide, trimethylene carbonate, e-caprolactone is used instead of a PTFE/silicone IPN film (10) so that the wound contacting surface (30) is semi-adherent by means of microporous capillary action and except curing is done by passing through the oven (230) at low temperature due to temperature sensitivity of the copolymer.

[0054] Preferably, in accordance with the invention, a method of managing a variety of wound types comprises the steps of providing a wound dressing of the invention, in which the wound dressing comprises multiple layers, wherein a first wound contacting layer is fenestrated or perforated semi-occlusive thin film membrane which is a semi-adhesive gel or other polymeric formulation that is inherently tacky, a second more distal layer is a non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh, and applying the wound dressing to a wound with the first wound contacting layer being against the wound, so that wound exudate passes through the wound dressing, while integration of the wound dressing into the wound and slippage and wrinkling of the wound dressing on the wound are limited. In this embodiment, the first wound contacting layer of the wound dressing, as well as the non-continuous silicone gel partially penetrating or otherwise adhering to an apertured mesh may include an antimicrobial substance, such as 3% by weight of a non-leaching polyquat antimicrobial (for example, 3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) or 3% by weight of silver oxysalts.

[0055] In accordance with the invention, a method of managing a wound comprises providing a wound dressing of the invention, in which the wound dressing comprises multiple layers, wherein a first wound contacting layer is a semi-adhesive gel or other polymeric film, a second more distal layer is an apertured mesh thus providing a moist healing environment for the wound, while (a) limiting slippage and wrinkling of the wound dressing on the wound, (b) permitting wound exudate to pass through the wound dressing, and (c) limiting integration of the wound dressing into the wound. In this embodiment, the first wound contacting layer of the wound dressing, as well as the silicone gel of the at least partially impregnated apertured mesh may include an antimicrobial substance, such as 3% by weight of a non-leaching polyquat antimicrobial (for example, 3-trihydroxysilylpropyldimethyloctadecyl ammonium chloride) or 3% by weight of silver oxysalts.

[0056] The apertured mesh may be woven or knitted textile material, or a nonwoven material, or an extruded scrim.

[0057] Preferably, in accordance with the invention, a method of manufacturing a multilayered wound dressing also comprises the steps of (1) creating a thin film with a suitable wound contacting gentle adhesive surface (that is, creating a thin film with a suitable wound contacting low tack surface), (2) creating an at least partially impregnated apertured mesh by at least partially impregnating an apertured mesh with a polymer gel so that apertures of the at least partially impregnated apertured mesh remain open to the passage of wound exudate, the apertured mesh having an outer surface that faces away from a wound application site, and (3) adhering the thin film and the at least partially impregnated apertured mesh together creating a multilayered wound dressing having a wound contacting surface and a distal surface, the wound contacting surface being the wound contacting gentle adhesive surface (that is, the wound contacting tacky surface) of the thin film and the distal surface being the outer surface of the apertured mesh. In a preferred embodiment of the method of manufacturing the multilayered wound dressing, the method may include a step of fenestrating the thin film to create openings for exudate passage. The thin film may be, for example, a semi-occlusive polymeric membrane such as a silicone/PTFE IPN membrane formulated to be inherently tacky and therefore have a gentle adhesive surface.