DE10139399A1 - Wound healing composition, especially useful for post-operative wounds, comprising acidic aqueous solution containing zinc and iron ions - Google Patents

Abstract

An aqueous solution (A) contains (in addition to water): zinc (10 - 100, preferably 15 - 45 mg), iron (6.5 - 65, preferably 10 - 30 mg) and sufficient acid to give a pH of 2.5 - 3.5 (preferably 2.8). An Independent claim is also included for a dressing for healing wounds using (A), consisting of a series of successive, bonded layers comprising a first, wound-contacting perforated layer, at least one (preferably several) absorbent layer(s) and a third outer layer, where the layer structure includes at least one chamber for delivery of (A).

Description

The invention relates to a dressing material according to the preamble of claim 1 and a treatment solution according to the preamble of claim 15.

It is generally known that wounds heal through a moist environment can be improved, in particular also supporting wound healing or media containing at least one medicament, for example solutions or Gels can be used. A currently practiced method exists in that the dressing material or one made of an absorbent material existing layer of this material soaked with the solution in question and then the dressing material is applied to the wound. The handling is here cumbersome and especially when treating larger and deeper wounds and in the event of frequent dressing changes, there is specially trained staff necessary.

The object of the invention is to show a dressing material that is soft Simplified application enables an improvement in wound healing. To the solution this task is a dressing material according to claim 1 educated. A treatment medium that is used with the dressing material can be designed according to claim 15.

The dressing material according to the invention has the advantage that it is easier Apply wound healing in a moist environment using this Media promoting wound healing and / or medications, in particular Solutions allowed, and also the amount of time within which a dressing change must be done, significantly increased. For example, when using the dressing material according to the invention possible, the dressing change only three days after the first treatment of a wound, d. H. at a time  who has also closed a deep wound so far that the danger of Infections is significantly reduced. Due to this long retention period of the Dressing material on the wound also becomes necessary for quick healing Wound rest, especially within the first few days after the wound has been treated guaranteed. This is possible because the chamber for the treatment medium via at least one connection led out of the dressing material to the Refill and / or replace the treatment medium.

In a preferred embodiment, which is characterized by a particularly inexpensive and effective structure of the dressing material is the chamber of formed at least one channel, which is in several sections and / or Spreads spread over the surface of the dressing material. This channel is then preferably at least one piece of hose.

Developments of the invention are the subject of the dependent claims. The invention is explained in more detail below with reference to the figures using exemplary embodiments. It demonstrate:

Fig. 1 shows a schematic partial illustration of the layer structure of the dressing material according to the invention, the individual actually interconnected in dressing material layers of greater clarity are shown separately because of the manner of an exploded view of each other;

FIG. 2 shows a simplified plan view of the material from FIG. 1;

Fig. 3 shows a schematic partial view of the layer construction of a further dressing material according to the invention;

Fig. 4-7 different graphics regarding the time course of wound healing in animal experiments.

The dressing material, generally designated 1 in the figures, which is also particularly suitable for treating open, deep wounds, is essentially designed as a multi-layer flat material, for example with a square or rectangular cut.

In the embodiment shown, the dressing material 1 consists of a first, external sterile layer 2 , which forms the support on the wound and of a perforated flat material, for example perforated film or grid made of a suitable plastic, for. B. is made of PVC. The single-layer outer layer 2 is followed by a layer 3 , which consists of several layers of a sterile; absorbent and air-permeable and moisture-permeable material, for example formed by a coarse fabric or a non-woven material. In the embodiment shown, the layer 3 consists of several layers of sterile gauze, for example four layers. The other surface side or outside of the dressing material 1 , which in use is the outer surface of this dressing material facing away from the wound, is formed by a layer 4 , which in the embodiment shown is of a single layer, consisting of a flat material or a film, preferably one plastic film. Layer 4 has semipermeable properties, ie it is permeable to air and gases, but not permeable to liquids. On the inner side of the layer 4 facing the layer 3 , a lumen or tube piece 5 is fastened, which extends in a meandering manner almost over the entire surface of the layer 4 and thus over the entire surface of the dressing material 1 and forms two ends or connections 6 , which are led out laterally from the dressing material 1 , in the embodiment shown in such a way that these ends 6 protrude on two opposite circumferential sides 1 'and 1 "of the dressing material.

The hose section 5 . which forms a channel for receiving and distributing a treatment medium, in particular a liquid or aqueous treatment medium, is carried out on its length within the dressing material 1 , ie between the layers 3 and 4 , in such a way that a finely distributed outlet of the treatment medium present in the tube piece 5 in layer 3 is possible. For this purpose, the piece of hose 5 is, for example, finely perforated. The projecting ends 6 are preferably each formed by a tube length that does not have this perforation.

The individual layers 2 , 3 and 4 with the tube piece 5 arranged between the layers 3 and 4 are connected to one another in a suitable manner, for example along the edge of the dressing material 1 and / or point-wise also within the dressing material 1 .

In use, the dressing material 1 is placed on the wound to be treated with the layer 2 and then fixed, for example, at the edge by means of an adhesive tape 7 or in some other way. In order to achieve improved wound healing in a moist environment, a solution suitable for wound treatment is supplied via one end 6 , for example via the upper end in FIG. 2, and until such solution emerges at the other end or connection 6 and thus the entire chamber formed by the tube piece 5 is filled with this treatment solution. Then both ends 6 are closed, for example with a suitable plug. The treatment solution emerging from the tube piece 5 is finely distributed over the entire dressing material over the layer 3 and thus in particular also over the entire wound area. The solution in the hose section 5 is renewed and replaced several times a day, for example twice a day.

Due to the dressing material according to the invention, the wound is optimal kept occlusive and moist, so that wound healing is significantly improved is achieved. The particular advantage of the dressing material according to the invention is but in that a change of dressing takes several days, for example is only necessary every three days, so that the first change of dressing material usually occurs at a time when there is even a deep, open wound has already concluded that the risk of an additional infection with Change of dressing must be excluded. Due to the large time interval between applying the dressing material and changing it for the first time  Dressing material is especially necessary for the first healing process Ensured restlessness within the first few days after a wound was treated. The dressing material according to the invention thus combines the advantages of wound healing in a humid environment with the advantage of a healing process especially in the first Long, restorative days.

FIG. 3 shows as a further embodiment of the invention in a schematic representation, in section, a Lind dressing material 1 a which is in turn carried layers and also of the improved wound healing is used in a damp environment. The dressing material 1 a consists of a lower layer 10 with which this material is placed on a wound. This layer 10 , which forms the sterile pad on the wound, is made of a sterile perforated flat material, for example a perforated or lattice-like film made of a suitable plastic, e.g. B. made of PVC or silicone.

A layer 11 is provided on the layer 10 , which serves as a distribution layer for the treatment liquid and is made, for example, of a sterile, soft and absorbent material, for example of gauze or of a nonwoven material (fleece). On the side of the layer 11 facing away from the layer 10 there is a layer 12 which contains the liquid treatment medium in encapsulated form, in such a way that the treatment medium is distributed over the layer 11 by opening or breaking the layer 12 or the capsules there the underside of the dressing material and thus on the wound area is released. A cover layer 13 is provided over the layer 12 , which consists of a semi-permeable flat material, ie a flat material which is not or largely impermeable to the liquid treatment medium, but is permeable to air and gases.

As is also shown in FIG. 3, the covering layer 13 also covers the dressing material 1 a or the different layers and layers of this dressing material laterally and is skin-compatible at the edge which is at the level of the underside of the layer 10 adhesive order 14 provided. The dressing material 1 a is sterile closed with a removable cover layer 15 on the side with which it is applied to a wound. Layer 15 is subtracted in use.

In use, the dressing material, after removal of the cover or protective layer 15 with the then exposed layer 10, is placed on the wound and fixed with the adhesive layer 14 around the wound. By breaking the layer 12 , the encapsulated treatment liquid is released.

The dressing material 1 a is preferably designed such that when a dressing is changed, the layer 10 of the existing dressing is separated from the adjacent layer 11 and the layer 10 thus remains on the wound, so that the rest of the wound and thus the healing process are not impaired by a dressing change become. The fresh dressing material used when changing the dressing then corresponds to the dressing material 1 a, but without the layer 10 , ie the formation is then made such that, in addition to the protective layer 15 , the layer 10 can also be removed from the dressing material 1 a if necessary.

As a treatment medium, for example, a solution is used which contains zinc and iron in aqueous solution, in addition to distilled water and sulfuric acid per liter of solution 10-100 mg Zn and 6.5-65 mg Fe, z. B. 15-45 mg Zn and 10-30 mg Fe, the proportion of sulfuric acid being chosen so that a pH value between 2.5 to 3.5, preferably 2.8. In a preferred embodiment, a 95-97% sulfuric acid is used. The distilled water is a double distilled water according to DAB 10. Suitable raw materials are, for example, ZnCl ₂ and FeSO ₄ , namely about 20-209 mg ZnCl ₂ and 32-325 mg FeSO ₄ per liter of solution.

An example of the composition of the treatment solution is given below:
Contains one liter of solution
Aqua bidestillata DAB 10: 980 g
FeSO ₄ : 0.097 g
ZnCl ₂ : 0.063 g
Remaining sulfuric acid 95-97% in a proportion until a pH of 2.8 is reached.

Due to the low pH of the treatment medium, this does not only create one acidic and therefore optimal wound environment. The acidic environment is particularly also stimulates the metabolism that promotes the healing process. It also works Treatment medium through the acid in connection with the iron content too microbacteriostatic, d. H. this creates a milieu that Prevents growth of germs and bacteria and has a repellent effect on them, so that inflammation from entering and developing a wound Germs are effectively prevented.

The treatment medium (solution) described above is also particularly suitable in connection with the dressing material 1 or 1 a, for example for use in skin transplants to supply or cover the transplant site, but also to supply the donor side (e.g. buttocks), where the transplanted skin was removed.

The above-described treatment medium (solution) is also particularly suitable in connection with the dressing material 1 or 1 a, inter alia, for the treatment of postoperative wounds and improves the healing process decisively, as has been demonstrated by tests on pigs. For this purpose, animal experiments were carried out on pigs using the treatment medium described above and the dressing material 1 . In these experiments, compared to wound healing in ambient air, a significantly accelerated healing process (shortening the healing process by about 5 days) and a substantial reduction in scar formation were found.

The above-described treatment medium (solution) is also particularly suitable in connection with the dressing material 1 or 1 a, inter alia, for the treatment of chronic wounds and burns, as was again found in animal experiments. To prove this, animal tests were carried out on pigs using the treatment medium described above with a proportion of 30 mg zinc and 20 mg iron per liter solution (hereinafter 0.003% solution), with a comparison solution containing only 10 mg zinc and approximately Contained 7 mg iron per liter solution (hereinafter 0.001% solution), with a comparison solution containing 100 mg zinc and 66 mg iron per liter solution (hereinafter 0.01% solution). In a further comparative series of experiments, the healing process in conventional wound care was examined.

The results of these combustion tests, as is generally recognized, are also meaningful for the effectiveness in the care of chronic wounds, such as z. B. pressure ulcers, leg ulcers, wound healing disorders in diabetes mellitus etc.

The results are shown in the graphs of FIGS. 4, 5, 6 and 7, specifically in FIG. 4 for the 0.001% solution, in FIG. 5 for the 0.01% solution, in FIG. 6 for the 0.003% solution and in FIG. 7 for a wound only exposed to ambient air. The illustrations show that the best healing results are achieved with the 0.003% solution.

The invention has been described above using an exemplary embodiment. It it goes without saying that numerous changes and modifications are possible without that this leaves the inventive idea on which the invention is based.  

LIST OF REFERENCE NUMBERS

1

.

1

a dressing material

1

'

1

"Perimeter

2

Layer of a sterile, perforated flat material made of plastic, for example made of PVC as a covering on the wound

3

Protective layer made of a sterile, soft and absorbent material, for example gauze

4

Layer of a semi-permeable material

5

hose Connector

6

Hose end or connection

7

duct tape

10

.

11

layer

12

location

13

covering

14

adhesive application

15

covering

Claims (20)

1. dressing material, consisting of a plurality of adjoining and interconnected layers, namely at least a first perforated layer ( 2 , 10 ) forming a support on the wound, a preferably multilayer soft and at the same time absorbent second layer ( 3 , 11 ) and from a third layer ( 4 , 13 ) forming the outer surface of the dressing material facing away from a wound, characterized in that within the layer sequence formed by the layers at least one chamber ( 5 , 12 ) dispenses a liquid treatment medium into the second layer ( 3 , 11 ) is provided. 2. Dressing material according to claim 1, characterized in that the at least one chamber ( 5 ) has at least one on an outside of the dressing material ( 1 ) accessible connection ( 6 ) for supplying a treatment medium and on a wall for finely distributed delivery of the treatment medium in the second layer ( 3 ) is formed. 3. Dressing material according to claim 1 or 2, characterized in that the at least one chamber ( 5 ) is finely perforated on its wall. 4. Dressing material according to one of the preceding claims, characterized in that the at least one chamber ( 5 ) is channel-like and extends with a plurality of channel sections and / or turns over the surface of the dressing material ( 1 ). 5. dressing material according to claim 4, characterized in that the at least one chamber (5) forms a respective terminal (5) at two ends. 6. dressing material according to one of the preceding claims, characterized in that the at least one chamber is formed by at least one tube piece ( 5 ). 7. Dressing material according to one of the preceding claims, characterized in that the at least one chamber ( 5 , 12 ) between the third layer ( 4 , 13 ) forming the outside of the dressing material and a further layer, for example the second layer ( 3 , 11 ) is provided. 8. Dressing material according to one of the preceding claims, characterized in that the at least one chamber ( 5 , 12 ) on the side of the second layer facing away from the second layer is provided adjacent to this. 9. Dressing material according to one of the preceding claims, characterized in that the at least one chamber ( 5 , 12 ) in the preferably multi-layer second layer ( 3 , 11 ) is provided. 10. Dressing material according to one of the preceding claims, characterized in that the third layer ( 4 , 13 ) is semipermeable, ie allows gas and air to pass through, but blocks liquid. 11. Dressing material according to one of the preceding claims, characterized in that the at least one connection ( 6 ) on one side of the dressing material ( 1 ) is guided out of it. 12. Dressing material according to one of the preceding claims, characterized in that the at least one tube piece ( 5 ) on the third layer ( 4 ) is fixed. 13. Dressing material according to one of the preceding claims, characterized in that the at least one chamber of at least one capsule for receiving the treatment medium, preferably of a layer ( 12 ) is formed from several capsules. 14. Dressing material according to one of the preceding claims, characterized in that the at least one chamber ( 5 , 12 ) serves to receive a treatment solution which contains, in addition to water and acid, preferably sulfuric acid, per liter of solution:
10-100 mg zinc (Zn)
6.5-65 mg iron (Fe)
for example
15-45 mg zinc
10-30 mg iron,
the proportion of acid being chosen so that a pH of about 2.5 to 3.5, preferably 2.8, is reached. 15. Treatment solution for use with the dressing material according to one of the preceding claims, in particular for promoting the acceptance of a graft, in particular of transplanted skin through the tissue at a transplantation location, characterized by an aqueous solution, preferably per liter of solution in addition to water and acid Sulfuric acid contains:
10-100 mg zinc (Zn)
6.5-65 mg iron (Fe)
for example
15-45 mg zinc
10-30 mg iron,
the proportion of acid being chosen so that a pH of about 2.5 to 3.5, preferably 2.8, is reached. 16. Treatment solution according to claim 15, characterized by the use of 95-97% sulfuric acid. 17. Treatment solution according to one of the preceding claims, characterized by the use of ZnCl ₂ as a zinc component, preferably in an amount of
10-100 mg per liter of solution, for example
46-80 mg per liter of solution. 18. Treatment solution according to one of the preceding claims, characterized by the use of FeSO ₄ as an iron component, preferably in an amount of
32-325 mg per liter of solution, for example
80-114 mg per liter of solution. 19. Treatment solution according to one of the preceding claims, characterized in that it contains about 30 mg of zinc and 20 mg of iron per liter of solution, preferably prepared using about 63 mg of ZnCl ₂ and about
97 mg FeSO ₄ . 20. Treatment solution according to one of the preceding claims, characterized characterized in that the aqueous solution in addition to zinc and iron only contains distilled water and acid, preferably sulfuric acid.