Film dressing for wound treatment

Abstract

The present invention relates to a transparent film dressing for wound treatment. On its underside, the film dressing has a more strongly adhesive edge region with an acrylate adhesive and a more weakly adhesive central region with a silicone gel. The film dressing according to the invention can adhere well to the wound site and has atraumatic properties. The film dressing according to the invention can also advantageously be used as a wound covering in negative-pressure wound therapy.

Description

[0001] Title: Film dressing for wound treatment

[0002] Description

[0003] The present invention relates to a film dressing for wound treatment. The present invention also relates to a kit and a system for negative pressure wound therapy using the film dressing. A method for producing the film dressing is also provided.

[0004] Film dressings for wound treatment are well known in the art. They are used for the treatment of dry or lightly exuding, primarily healing wounds, nearly healed epithelializing wounds, and for securing wound dressings, catheters, and cannulas. Furthermore, film dressings are also used as a sealing wound cover in negative pressure wound therapy in combination with at least one additional dressing layer, such as an open-cell foam as a wound filler. Film dressings in the sense intended here do not contain any absorbent dressing layers. Therefore, they are not suitable on their own for the treatment of heavily bleeding or exuding wounds.

[0005] A typical film dressing is simple in design and consists of a single-sided, liquid-impermeable, and water vapor-permeable plastic film with an adhesive coating. The film dressing may also include support and protective films as an application aid. These are removably attached to the non-adhesive top or the adhesive underside of the plastic film and can be removed by the user when the film dressing is applied to the patient's body.

[0006] The adhesive layer of the film dressing can, for example, be made of an acrylate adhesive. Acrylate adhesives can exhibit high adhesive strength. This allows the film dressing to adhere well and permanently to the patient's body and be used to hermetically seal a negative pressure wound therapy dressing. However, the high adhesive strength of the acrylate adhesive can, in some cases, lead to pain and damage to the wound surface and possibly even to intact skin in the peri-wound area when the film dressing is removed from the patient's body, for example, during a dressing change.

[0007] The object of the present invention was to provide an improved film dressing for wound treatment. The film dressing should adhere as well and permanently as possible to the patient's body and be able to be used for the airtight closure of a negative pressure wound therapy dressing. Furthermore, the film dressing should cause as little or no pain and damage to the skin and wound surface as possible when the film dressing is removed from the patient's body. These objects were achieved with a film dressing according to claim 1, a kit for negative pressure wound therapy according to claim 13, a system for negative pressure wound therapy according to claim 14, and a manufacturing method according to claim 15.

[0008] The film dressing according to the invention comprises several film layers and several adhesive layers, which are specified below: i. A first, liquid-impermeable and water vapor-permeable plastic film with a top side and a bottom side. The first plastic film forms the backing layer of the film dressing, i.e. the outermost layer of the film dressing when the film dressing is attached to the patient's body. ii. A first adhesive layer with a top side and a bottom side. The entire top side of the first adhesive layer is arranged directly on the underside of the first plastic film and consists of an acrylate adhesive. iii. A second adhesive layer with a top side and a bottom side. The entire top side of the second adhesive layer is arranged directly on the underside of the first adhesive layer and consists of an acrylate adhesive. iv. A second plastic film with a top side and a bottom side.The entire top surface of the second plastic film is positioned directly against the underside of the second adhesive layer. v. A third adhesive layer with a top surface and a bottom surface. The third adhesive layer is positioned with its entire top surface directly against the underside of the second plastic film and is made of a silicone gel.

[0009] The first plastic film forms a first composite with the first adhesive layer. The second plastic film, in turn, forms a second composite with the second and third adhesive layers. Further key features of the film assembly according to the invention are that the first composite projects beyond the second composite and the second composite is perforated. Because the first composite projects beyond the second composite, the film assembly has an adhesive edge consisting of the first plastic film and the first adhesive layer. The perforations in the second composite are continuous perforations. This means that the perforations penetrate all three layers of the second composite (second adhesive layer, second plastic film, and third adhesive layer) equally, so that liquids and gases can easily pass through the second composite.The perforations in the second composite can improve the water vapor permeability (breathability) of the film composite.

[0010] The terms film and foil are used synonymously in this document. Therefore, the film assembly in question could also be referred to as a foil assembly, or the first plastic foil could also be referred to as the first plastic film.

[0011] When used as intended, the upper side of a layer of the film dressing faces away from the skin or wound. Similarly, when used as intended, the underside of a layer of the film dressing faces the skin or wound.

[0012] For the purposes of the present invention, one side of a layer is directly attached to the side of another layer when the sides of the two layers are in direct contact with each other and thus touch each other. Consequently, the sides of the two layers must not be spaced or separated from each other by an intermediate layer.

[0013] The underside of the prior art film dressing mentioned in the introduction to the description, intended for application to the skin or wound surface, is formed exclusively from a highly adhesive acrylate adhesive. In contrast, the underside of the present film dressing features an advantageous adhesive combination of a more strongly adhesive acrylate adhesive in the edge region and an atraumatic, less strongly adhesive silicone gel in the central region. Due to the more strongly adhesive edge with the acrylate adhesive, the film dressing can adhere well and permanently to the patient's body and can be used to hermetically seal a negative pressure wound therapy dressing. Therefore, additional means for attaching or sealing the film dressing, such as the hydrogel strips, adhesive strips, spool plasters, or similar known from EP 0 782 421 B1, are generally not required.Due to the atraumatic, less adhesive central area with the silicone gel, the film dressing causes no, or at least less, pain and damage to the skin and wound surface when the film dressing is removed from the patient's body. Furthermore, the film dressing according to the invention is also comparatively easy to manufacture. Further advantages of the present film dressing emerge from the preferred embodiments described below.

[0014] Preferably, the first and second plastic films, as well as the first to third adhesive layers, are essentially transparent. This allows the skin and wound surface to be inspected without removing the film dressing from the wound site. This can, for example, prevent unnecessary dressing changes.

[0015] The first plastic film can be formed as a closed, continuous layer, with the exception of the opening in the film assembly described below. Furthermore, the first plastic film is preferably made of polyurethane. The thickness of the first plastic film can be 10 μm to 100 μm, preferably 15 μm to 35 μm, and in particular approximately 20 μm.

[0016] The first adhesive layer can also be formed as a closed, continuous layer, apart from the opening in the film assembly described below. It is typically applied as a coating, in particular as a full-surface coating, to the first plastic film. The first plastic film represents the carrier material for the first adhesive layer. It is also conceivable for the first adhesive layer to be patterned, for example, in a grid or stripe pattern (pattern coating). This can improve the water vapor permeability of the film assembly. Furthermore, the thickness of the first adhesive layer can be between 20 μm and 60 μm.

[0017] The adhesive strength of the first adhesive layer can be more than 2.8 N / 25 mm, preferably more than 3.5 N / 25 mm, and particularly preferably more than 4 N / 25 mm. To prevent the film dressing from adhering too strongly to the wound site, the adhesive strength of the first adhesive layer is preferably no more than 12 N / 25 mm. The adhesive strength of the first adhesive layer can be determined according to DIN EN ISO 29862:2019 (Method 1), although deviations from the standard are permitted in the following points: • Polypropylene sheets (PP sheets) are used as the substrate instead of steel sheets.

[0018] The PP plates can have dimensions of 150 mm x 50 mm x 4 mm and are designed as disposable test specimens, with the test side covered with film. The film is removed before the test. The PP plates can correspond to the steel plates specified in the standard in terms of their surface finish. Accordingly, the PP plates are typically completely flat and have a smooth (test) surface.

[0019] • The sample width is 25 mm instead of 24 mm.

[0020] • The waiting time is 20 min instead of < 1 min (i.e. the sample is only measured 20 min after it has been applied to the PP plate).

[0021] • If necessary, an extension tape is used if the sample is too short (for example, the tape Scotch 8959).

[0022] • If necessary, a reinforcing tape is used if the sample is elastic (for example the tape Tesa 4104).

[0023] To determine the bond strength of the first adhesive layer, a tensile testing machine according to DIN EN ISO 7500-01:2018-06, Class 1, can be used. The measurement results can be evaluated according to DIN ISO 6133:2017-04 (Method B).

[0024] The thickness of the second adhesive layer can be 30 μm to 50 μm. The adhesive strength of the second adhesive layer can be 2 N / 25 mm to 7 N / 25 mm, in particular approximately 4.5 N / 25 mm. The adhesive strength of the second adhesive layer can be determined according to FINAT No. 1 (FTM 1 Peel adhesion (90°) at 300 mm per minute), whereby deviations from the standard are permitted in the following points:

[0025] • A steel plate is used as the substrate instead of glass. The steel plate can have dimensions of 50 mm x 150 mm (width x length) and is typically completely flat and smooth.

[0026] • The control atmosphere is 20 ± 2 °C, 60 ± 5 % RH or 23 ± 2 °C, 50 ± 5 % RH.

[0027] • The measurements are carried out immediately after the preparation of the samples.

[0028] Like the first plastic film, the second plastic film is preferably made of polyurethane. As will become clear later, in the manufacturing process of the present film assembly, the second plastic film typically forms the carrier material for the second and third adhesive layers, which are applied as coatings to both sides of the second plastic film. The resulting three-layer composite is then perforated to make it permeable to liquids and gases. The thickness of the second plastic film can be 20 μm to 30 μm, for example, approximately 25 μm.

[0029] According to the invention, the third adhesive layer consists of a silicone gel. Silicone gels for wound dressings are known to those skilled in the art, as are acrylate adhesives, and are described in more detail, for example, in EP 4218698 A1. The thickness of the third adhesive layer can be 80 μm to 200 μm, preferably 100 μm to 150 μm.

[0030] The silicone gel of the third adhesive layer has a lower adhesive strength than the acrylic adhesive of the first adhesive layer. Accordingly, the adhesive strength of the third adhesive layer is preferably only 1.5 N / 25 mm to 2.7 N / 25 mm. The adhesive strength of the third adhesive layer can be determined according to FINAT No. 1 (FTM 1 Peel adhesion (180°) at 300 mm per minute), although deviations from the standard are permitted in the following points:

[0031] • Bristol paper is used as the substrate instead of glass. The Bristol paper can be, for example, Oxford, plain white paper, non-perforated, reference 237000.

[0032] • The control atmosphere is 20 ± 2 °C, 60 ± 5 % RH or 23 ± 2 °C, 50 ± 5 % RH.

[0033] • Measurements are performed within 20 minutes of sample preparation.

[0034] As already described, the first plastic film forms a first composite with the first adhesive layer, and the second plastic film forms a second composite with the second and third adhesive layers. The layers contained in the first composite, namely the first plastic film and the first adhesive layer, are usually congruent and lie exactly (flush) on top of one another. The same applies to the second composite. Thus, the layers contained in the second composite, namely the second plastic film, the second adhesive layer, and the third adhesive layer, are also usually congruent and lie exactly (flush) on top of one another.

[0035] The first composite is larger in area than the second composite and can therefore extend laterally beyond the second composite, forming the aforementioned adhesive edge of the film dressing. The adhesive edge is intended to be attached to intact skin, not to the wound surface or wound edges. The adhesive edge ensures the secure hold of the film dressing on the patient's body. The adhesive edge can, for example, have a width of 1.5 cm to 5 cm.

[0036] The second composite is normally positioned substantially centrally on the first composite and is normally dimensioned such that the adhesive edge can completely surround the second composite. The second composite is thus attached to the adhesive backing layer in a similar way to the absorbent wound pad in a classic island dressing. Furthermore, the second composite can have a basis weight of 150 g / m².2 up to 200 g / m 2 70 g / m 2 up to 130 g / m 2to the silicone gel. In addition, the second composite or the third adhesive layer of the second composite can form 30% to 90%, preferably 30% to 80%, more preferably 30% to 70% and particularly preferably 50% to 70% of an underside of the film dressing, whereby the reference is to the adhesive underside of the film dressing without an optional protective layer. In addition, the open area created by the perforations in the second composite can be disregarded. With a smaller proportion of siliconized surface, the adhesive strength of the film dressing is higher. With a larger proportion of siliconized surface, the adhesive strength of the film dressing is lower. A higher adhesive strength (and thus a larger adhesive edge area) can be advantageous if the film dressing is to be used on uneven or mobile parts of the body (e.g. elbows, knees) or for negative pressure wound therapy.A lower adhesive force (and thus a smaller adhesive edge area) can be advantageous if the film dressing is to be used on particularly sensitive skin.

[0037] The perforations in the second composite can, in particular, be substantially round. Their diameter can then be 0.5 mm to 3 mm, preferably 0.5 mm to 2 mm, more preferably 0.5 mm to 1.5 mm, and particularly preferably 0.5 mm to 1 mm. Furthermore, the perforations are preferably distributed at regular intervals over the entire surface of the second composite. The perforations can be cut or punched into the second composite.

[0038] The film dressing generally further comprises at least one protective film, preferably two protective films, each with a top side and a bottom side. The top side of each protective film is removably arranged directly on the underside of the first adhesive layer in the region of the adhesive edge and the third adhesive layer. The protective films protect the adhesive underside of the film dressing from contamination and facilitate handling of the film dressing. They are removed by the user when the film dressing is attached to the patient's body. In order to stabilize the film dressing after removal of the protective films and thus improve handling of the film dressing, the film dressing can further comprise at least one backing film, preferably two backing films, each with a top side and a bottom side. The underside of each backing film is removably arranged directly on the top side of the first plastic film.Like the aforementioned protective films, the support films are removed by the user when the film dressing is applied to the patient's body. Both the protective films and the support films can be made of a plastic material or paper, especially siliconized paper. Ultimately, the protective films and support films are peel-off films that form an application aid or application system for the film dressing.

[0039] To make it easier to distinguish the protective films from the support films, and thus also the underside from the top side of the film dressing, the protective and support films advantageously have labels and / or markings, in particular colored markings. For example, in an application system with two protective and support films each, the two protective films can be labeled with the numbers 1 and 2, and the two support films with the numbers 3 and 4. Such numbering would advantageously also indicate that the protective films should be removed from the film dressing first. In addition, the protective films and / or support films can have a marking for the position or width of the adhesive edge. This can simplify the intended attachment of the film dressing to the wound site.

[0040] The present film dressing itself, as is usual with transparent post-operative dressings, does not contain a wound pad for absorbing fluid or for distributing fluid or pressure. Typically, the present film dressing consists of the following components already described: i. the first plastic film ii. the first adhesive layer iii. the second adhesive layer iv. the second plastic film v. the third adhesive layer vi. optionally the at least one protective film vii. optionally the at least one support film Contact of the first adhesive layer with the skin or wound surface through the perforations in the second composite can impair the atraumatic properties of the film dressing and should therefore advantageously be prevented or at least minimized as far as possible.Accordingly, the film dressing is preferably designed such that only the first adhesive layer in the region of the adhesive edge and the third adhesive layer can come into contact with a patient's skin or wound surface when the film dressing is attached to the patient's body. The following preferred embodiment of the invention describes in more detail how this can be achieved.

[0041] In a preferred embodiment of the invention, the film dressing is designed such that the first adhesive layer cannot penetrate into the perforations of the second composite to the underside of the third adhesive layer when pressure is exerted on the upper side of the first plastic film. Otherwise, the first adhesive could be forced through the perforations and adhere to the skin and wound surface. As already mentioned, this could impair the advantageous and desired atraumatic properties of the film dressing. Whether the first adhesive layer can penetrate into the perforations of the second composite to the underside of the third adhesive layer will depend in particular on the extensibility and flexibility of the first plastic film, the thickness of the film layers, the thickness of the adhesive layers, and the size of the perforations.

[0042] Although the adhesive underside of the present film dressing is partially siliconized and thus less adhesive, the film dressing can nevertheless be used, similar to the highly adhesive film dressings of the prior art, without an additional, separately provided means for securing and / or sealing the film dressing. The film dressing can therefore be intended or designed to be used for wound treatment without an additional, separately provided means for securing and / or sealing the film dressing to a patient's body. If such an additional means is not required, the costs of wound care can be reduced, among other things.

[0043] The general application of film dressings has already been described above. This film dressing can be used advantageously for the treatment of dry or only slightly exuding, primary healing wounds, as well as nearly healed epithelializing wounds. The film dressing is attached to the wound site without any additional dressing materials and forms the primary wound dressing. In this application, the adhesive edge with the acrylic adhesive is brought into direct contact (only) with intact skin in the peri-wound area, and the silicone gel is brought into direct contact with the wound surface. Thus, the second composite, or rather the silicone gel of the second composite, acts as the wound contact layer of the film dressing in this application.

[0044] The film dressing according to the invention can also be advantageously used as a sealing wound covering in negative pressure wound therapy. The wound is first filled with a porous wound dressing for distributing negative pressure, for example, a gauze or an open-cell foam. The film dressing is then attached to the wound site over the (primary) wound dressing and seals the wound site. As in the previously described application, the adhesive edge of the film dressing is (only) attached to intact skin in the peri-wound area and ensures the secure hold and tightness of the negative pressure therapy dressing. The atraumatic, siliconized area of ​​the film dressing then covers at least the wound edges and the wound filling material.Although the film dressing is used as a secondary dressing material and therefore does not form the immediate wound contact layer, it can at least better protect the wound edges and the periwound skin from damage during dressing changes. This makes dressing changes more comfortable for the patient.

[0045] In order to create negative pressure in the wound space, an opening is typically made in the film dressing. A suction tube, which is connected to a negative pressure source, is connected to the opening. The opening can be cut into the film dressing by the user. The film dressing can also be provided with an opening by the manufacturer if it is specifically intended for use in negative pressure wound therapy. Accordingly, in one embodiment the film dressing has an opening for suctioning out air during negative pressure wound therapy. The opening penetrates at least the first plastic film, the first adhesive layer, the second adhesive layer, the second plastic film and the third adhesive layer. The opening can also penetrate protective and support films, if present.The opening can, for example, be essentially round and have a diameter of 0.5 cm to 2.5 cm. In any case, the handling of the film dressing in negative pressure wound therapy can be improved with the manufacturer's opening, as the user no longer has to create the opening themselves, thus saving them a step in dressing the wound.

[0046] Another object of the present invention is a dressing kit for negative pressure wound therapy. The kit comprises the following components:

[0047] - a film assembly according to the invention as described above

[0048] - a wound filling material

[0049] - a suction hose for connecting the film dressing to a vacuum source

[0050] - optionally an instruction manual

[0051] The kit makes it easy to provide the user with all the essential dressing materials needed to treat a wound using negative pressure wound therapy.

[0052] The kit is preferably sterile. Furthermore, the kit can also be provided without an additional, separately provided means for securing and / or sealing the film dressing to a patient's body.

[0053] Another object of the present invention is a system for negative pressure wound therapy. The system comprises the following components:

[0054] - a film assembly according to the invention as described above

[0055] - a wound filling material

[0056] - a negative pressure source

[0057] - a suction hose to connect the film dressing to the vacuum source.

[0058] The negative pressure source may include a replaceable container for collecting the suctioned wound exudate.

[0059] In addition, a method for producing the film dressing according to the invention is specified. The method comprises the following steps: i. Providing a first, liquid-impermeable and water vapor-permeable plastic film having a top side and a bottom side. ii. Coating, for example pattern coating or in particular full-surface coating, the bottom side of the first plastic film with an acrylate adhesive, thereby obtaining a first composite. iii. Providing a second plastic film having a top side and a bottom side. iv. Coating, in particular full-surface coating, the top side of the second plastic film with an acrylate adhesive and the bottom side of the second plastic film with a silicone gel, thereby obtaining a second composite. v. Creating perforations in the second composite, in particular by cutting or punching. vi.Bringing the acrylate adhesive of the first composite into contact with the acrylate adhesive of the second composite so that the first composite and the second composite are bonded together.

[0060] The first composite and the second composite are designed with regard to their size (area) in such a way that the first composite can project beyond the second composite and thus form an adhesive edge of the film assembly as described above.

[0061] By bringing two acrylic adhesive layers into contact with each other in process step vi, a particularly good bond between the second composite and the first composite can be achieved. This reduces the risk of delamination of the film assembly.

[0062] The film dressing can be used in all of its previously described embodiments for the kit and the system and can be manufactured using the method. The additional features of the film dressing in its specific embodiments are therefore also disclosed in connection with the kit, the system, and the method.

[0063] Figures

[0064] The following schematic figures are intended to explain and illustrate the invention in more detail by way of example. Similar structural elements may be identified by the same reference numerals in the figures.

[0065] Figure 1 shows a first embodiment of a film dressing 1 according to the invention in a side sectional view. The film dressing 1 comprises a liquid-impermeable and water vapor-permeable plastic film 2 (first plastic film). On its underside, the plastic film 2 is fully coated with an acrylate adhesive 3 (first adhesive layer). A three-layer, perforated composite (second composite) is attached to the adhesively coated plastic film 2, 3 (first composite). This consists of a plastic film 4 (second plastic film), which is coated on its upper side with an acrylate adhesive 5 (second adhesive layer) and on its underside with a silicone gel 6 (third adhesive layer). The adhesive plastic film 2, 3 projects beyond the three-layer, perforated composite 4, 5, 6, so that the film dressing has an adhesive edge 7. The film dressing 1 also comprises an application system.This comprises a two-part protective film 8 with grip tabs 9 and a two-part support film 10 with grip tabs 11. The grip tabs 9, 11 allow the user to more easily remove the application system when attaching the film dressing 1 to the wound site. After the protective and support films 8, 10 have been removed from the film dressing 1 and the film dressing 1 has been attached to the wound site as intended, the plastic film 2 forms the backing layer, i.e. the outermost layer of the film dressing 1. The composite 4, 5, 6 or its silicone gel 6 is in contact with the wound surface and thus forms a wound contact layer at least when the film dressing 1 is used as a primary wound dressing and not as a secondary wound dressing (as shown in Figure 4). Since the film dressing 1 (without the application system) is transparent, the condition of the wound and its healing process can advantageously be easily determined at any time.

[0066] Figure 2 shows the film dressing 1 from Figure 1 with a view of its adhesive underside (without protective films 8). Visible here is the central arrangement of the silicone-coated composite 4, 5, 6 with the surrounding adhesive edge 7 as well as the perforations 12, which penetrate the centrally arranged composite 4, 5, 6. The number, size, and shape of the perforations 12 are to be understood as examples. In particular, the perforations 12 can also be round and smaller. Due to the more strongly adhesive edge region in combination with the less adhesive central region, the film dressing 1 can, as already described, both adhere well to the wound site and exhibit atraumatic properties.

[0067] Figure 3 shows the underside of a film dressing 13 according to the invention in a second embodiment, which is specifically intended for use in negative pressure wound therapy. The film dressing 13 differs from the film dressing 1 only in that it additionally has an opening 14 for extracting air during negative pressure wound therapy. The opening 14 is located centrally in the film dressing 13 and is much larger than the perforations 12. Furthermore, it penetrates not only the second composite 4, 5, 6, but also the first composite 2, 3.

[0068] Finally, Figure 4 shows a system 15 for negative pressure wound therapy. The system 15 comprises a porous wound filler 16, which fills the wound. The wound filler 16, for example, an open-cell polyurethane foam, is tailored to fit the wound and represents the primary wound contact dressing. The wound filler 16 serves as a negative pressure distributor and ensures that fluids and gases can be suctioned out of the wound. The system 15 also comprises the film dressing 13 from Figure 3 as a secondary wound covering. For simplicity, some layers of the film dressing 13 have been combined in Figure 4. The film dressing 13 is attached to the wound site in such a way that it forms an airtight seal around the wound lined with the wound filler 16, except for the opening 14. The adhesive edge 7 is attached to intact skin 17 in the wound area and the siliconized central area is additionally attached to the wound edge 18 and the wound filler 16.Finally, the system 15 also includes a vacuum source 19 and a suction hose 20. The suction hose 20, connected to the vacuum source 19, is hermetically sealed to the outside of the film dressing 13 in the area of ​​the opening 14. This allows the negative pressure generated by the vacuum source 19 to be transmitted to the wound and maintained in the wound space during negative pressure wound therapy. Negative pressure wound therapy with the system 15 can, thanks to the atraumatic film dressing 13, particularly protect the wound edge 18 during dressing changes.

[0069] The film dressings shown in the figures are rectangular in shape. However, the film dressings can also have other shapes, for example round or oval. Likewise, it is envisaged that the film dressings according to the invention will be made available not only in different shapes, but also in different sizes. Dressings in different shapes and sizes are common practice in wound care so that a suitable dressing is available and can be selected for every wound, regardless of where it is located on the patient's body and regardless of its size. Cutting a film dressing according to the invention to size is theoretically possible. However, this may then result in the adhesive edge being missing and the adhesive strength at the cut edge being too low. Therefore, this film dressing should not be cut if possible.

Claims

Patent claims 1. A film dressing (1, 13) for wound treatment, comprising i. a first, liquid-impermeable and water vapor-permeable plastic film (2) with a top side and a bottom side, ii. a first adhesive layer (3) with a top side and a bottom side, wherein the first adhesive layer (3) is arranged with its entire top side directly on the bottom side of the first plastic film (2) and consists of an acrylate adhesive, iii. a second adhesive layer (5) with a top side and a bottom side, wherein the second adhesive layer (5) is arranged with its entire top side directly on the bottom side of the first adhesive layer (3) and consists of an acrylate adhesive, iv. a second plastic film (4) with a top side and a bottom side, wherein the second plastic film (4) is arranged with its entire top side directly on the bottom side of the second adhesive layer (5), and v.a third adhesive layer (6) with a top side and a bottom side, wherein the third adhesive layer (6) is arranged with its entire top side directly on the bottom side of the second plastic film (4) and consists of a silicone gel, wherein the first plastic film (2) forms a first composite (2, 3) with the first adhesive layer (3) and the second plastic film (4) forms a second composite (4, 5, 6) with the second and third adhesive layers (5, 6), wherein the first composite (2, 3) projects beyond the second composite (4, 5, 6) so that the film assembly (1, 13) has an adhesive edge (7) consisting of the first plastic film (2) and the first adhesive layer (3), and wherein the second composite (4, 5, 6) is perforated.

2. Film dressing (1, 13) according to claim 1, wherein the first and second plastic films (2, 4) and the first to third adhesive layers (3, 5, 6) are substantially transparent.

3. Film dressing (1, 13) according to claim 1 or 2, wherein the adhesive strength of the first adhesive layer (3) is more than 2.8 N / 25 mm, preferably more than 3.5 N / 25 mm, and particularly preferably more than 4 N / 25 mm.

4. Film dressing (1, 13) according to one of the preceding claims, wherein the adhesive strength of the third adhesive layer (6) is 1.5 N / 25 mm to 2.7 N / 25 mm.

5. Film dressing (1, 13) according to one of the preceding claims, wherein the second composite (4, 5, 6) forms 30% to 90%, preferably 30% to 80%, more preferably 30% to 70% and particularly preferably 50% to 70% of an underside of the film dressing (1, 13).

6. Film dressing (1, 13) according to one of the preceding claims, wherein the film dressing (1, 13) further comprises at least one protective film (8) having a top side and a bottom side, wherein the protective film (8) is detachably arranged with its top side directly on the bottom side of the first adhesive layer (3) in the region of the adhesive edge (7) and the third adhesive layer (6).

7. Film dressing (1, 13) according to one of the preceding claims, wherein the film dressing (1, 13) further comprises at least one support film (10) having a top side and a bottom side, wherein the support film (10) is detachably arranged with its bottom side directly on the top side of the first plastic film (2).

8. Film dressing (1, 13) according to one of the preceding claims, wherein the film dressing (1, 13) consists of i. the first plastic film (2), ii. the first adhesive layer (3), iii. the second adhesive layer (5), iv. the second plastic film (4), v. the third adhesive layer (6), vi. optionally the at least one protective film (8), and vii. optionally the at least one support film (10).

9. Film dressing (1, 13) according to one of the preceding claims, wherein the film dressing (1, 13) is designed such that only the first adhesive layer (3) in the region of the adhesive edge (7) and the third adhesive layer (6) can come into contact with a skin or wound surface of a patient.

10. Film dressing (1, 13) according to one of the preceding claims, wherein the film dressing (1, 13) is designed such that the first adhesive layer (3) cannot penetrate into the perforations (12) of the second composite (4, 5, 6) up to the underside of the third adhesive layer (6).

11. A film dressing (1, 13) according to any one of the preceding claims, wherein the film dressing (1, 13) is intended to be used for wound treatment without a separately provided means for securing and / or sealing the film dressing (1, 13) to the body of a patient.

12. Film dressing (13) according to one of the preceding claims, wherein the film dressing (13) has an opening (14) for suctioning out air in the context of negative pressure wound therapy.

13. Kit for negative pressure wound therapy, comprising - a film assembly (1, 13) according to one of the preceding claims, - a wound filling material, - a suction hose for connecting the film dressing to a vacuum source, and - optionally an instruction manual.

14. System (15) for negative pressure wound therapy, comprising - a film assembly (13) according to one of claims 1 to 12, - a wound filling material (16), - a vacuum source (19), and - a suction hose (20) for connecting the film dressing (13) to the vacuum source (19).

15. A method for producing a film dressing (1, 13) according to any one of claims 1 to 12, wherein the method comprises the following steps: i. Providing a first, liquid-impermeable and water vapor-permeable plastic film (2) having a top side and a bottom side, ii. Coating, for example pattern coating or in particular full-surface coating, the bottom side of the first plastic film (2) with an acrylate adhesive (3), whereby a first composite (2, 3) is obtained, iii. Providing a second plastic film (4) having a top side and a bottom side, iv. Coating, in particular full-surface coating, the top side of the second plastic film (4) with an acrylate adhesive (5) and the bottom side of the second plastic film (4) with a silicone gel (6), wherein a second Composite (4, 5, 6) is obtained, v. Creating perforations (12) in the second composite (4, 5, 6), in particular by cutting or punching, vi. Bringing the acrylate adhesive (3) of the first composite (2, 3) into contact with the acrylate adhesive (5) of the second composite (4, 5, 6), so that the first Composite (2, 3) and the second composite (4, 5, 6) are connected to one another, wherein the first composite (2, 3) and the second composite (4, 5, 6) are designed such that the first composite (2, 3) projects beyond the second composite (4, 5, 6) and can thus form an adhesive edge (7) of the film assembly (1, 13).

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