GREEN ARTICLE FOR USE IN WOUND TREATMENT

TECHNICAL FIELD

The present invention relates to an article for use in wound treatment. The invention also relates to an apparatus for treating wound with negative pressure, said apparatus including a pump for providing said negative pressure to the wound, a wound filler and a sealing film.

BACKGROUND ART

Polymer foam has been used for decades as wound filling material. Normally one has used open-cell foam that can transport body fluids through its network but also perforated closed-cell foam has been suggested.

A highly absorbent hydrophilic polyurethane foam is known from EP 0 335669. This application was filed 1988.

From for instance EP 0620720 A, which was filed with priority from 1991, is known a substantially flat section of open cell polyester foam (Fischer Scientific, Pittsburgh, Pa. 15219) which is said to be sufficiently large to cover the wound and thus prevent wound overgrowth.

In US patent application 2008208147A, filed in 2007, is mentioned that open-cell polymer foam may be used as wound filler. The examples of polymer foam mentioned in said application are GranuFoam and WhiteFoam™ dressings marketed by Kinetic Concepts Inc, San Antonio, Tex.

Healing of wound with negative pressure is today an accepted method for treating difficult and with earlier conventional methods slow-healing wounds.

Drainage of, for example, surgical wounds or other weeping wounds with negative pressure is a standard treatment which has been used for decades. An example of a manual suction pump for this purpose is described in U.S. Pat. No. 3,742,952.

U.S. Pat. No. 3,572,340 describes a pump in the form of an elastically compressible body made of an open-celled foam material, preferably a polyurethane foam, which body also serves as a receptacle for fluid drained from the wound. The pump is said to have a capacity to maintain a negative pressure of 15-80 mmHg for more than 48 hours. A perforated drain is intended to be placed in the wound pocket and is connected to the pump by a tube. A similar device is described in U.S. Pat. No. 4,525,166, in the description of which it is specifically stated that the negative pressure not only drains wound fluid but also draws together the wound edges and stimulates tissue growth and healing of the wound. The two latter publications therefore state that vacuum treatment of wounds stimulates wound healing.

The terms vacuum treatment, treatment with reduced pressure and treatment under negative pressure are used interchangeably in the literature. It should be pointed out that, where these terms are used within this description, treatment at a pressure below normal atmospheric pressure is always meant.

Vacuum treatment of wounds is described in for instance U.S. Pat. No. 4,969,880, U.S. Pat. No. 5,645,081, U.S. Pat. No. 5,636,643, U.S. Pat. No. 6,855,135 and WO 2006/025848 A2. These publications mention the use of polymer foam as wound filling material.

Use of polymer foam in wound dressing and as wound filler in connection with negative pressure treatment of wound is thus known since decades as mentioned above.

Polymer foams that exist on the market for use as dressings and as wound filler in connection with negative pressure treatment performs well in many respects but all hitherto known foams for said uses can be improved as will be set forth below in the presentation of the present invention.

GranuFoam, marketed by Kinetic Concepts Inc, San Antonio, Tex. in connection with negative pressure treatment, is a black polyurethane foam. One advantage with black is that this colour differs from other colours in the wound care area. An essential drawback with this black foam is however that a user or a caretaker, such as a nurse, will not be able to see when blood or pus is present in the foam. It is obvious that this in certain situations can be a serious disadvantage.

WhiteFoam™ also marketed by Kinetic Concepts Inc, San Antonio, Tex. is as the name indicates a white polyurethane foam. It is true that pus and blood will be visible for a user or a caretaker but this is in fact nevertheless a serious drawback. A patient with a white foam as dressing can be scared and worried when blood and/or pus is clearly visible in the white foam. A further disadvantage with white foam is that the foam is not in sharp contrast to other material used in wound. A further more serious risk is that a white foam coloured with blood will not distinguish satisfactorily in a surrounding with blood flow and it is a risk that white foam is left behind in a wound.

The above mentioned problems with existing foam have hitherto not been fully realized or addressed.

The object with the present invention is to find a polymer foam which solves the above mentioned problems with hitherto known polymer foam in the wound care area.

Above has been mentioned the problems with foam used in connection with negative pressure treatment. The problems with hitherto used colour of polymer foam as wound filling material is of course relevant for polymer foam and for other materials that are used in wound treatment in, over, and near the wound area. Another obvious example is gauze which hitherto primarily has been white.

DISCLOSURE OF INVENTION

An article for use in wound treatment is according to the invention characterized in that the article is coloured in a chosen colour, in that the chosen colour is green, and in that the chosen colour in dry state has the following mean values

a lightness factor L* along the black-white axis of between 20-55 according to Test Method T-397,
a chromatic coordinate a* along the red-green axis of between −45 to −20 according to Test Method T-397, and
a chromatic coordinate b* along the yellow-blue axis of between −4.0 to −1.0 according to Test Method 1-397.

The inventive concept is that the colour of the article stands out in clear contrast against body tissue and body fluids, such as pus and blood, and also that the article hides the colour of body fluids, such as pus and blood, present in the article and make the presence of body fluids visible through a differentiation in the chosen colour of the article, which differentiation occur when the article in the chosen colour have taken up body fluids, such as pus and/or blood.

According to one embodiment the invention is characterized in that said article is made of cotton, such as gauze.

According to another embodiment the invention is characterized in that said article is made of a non-woven material.

According to one embodiment the invention is characterized in that that said article is made of a netting material.

According to another embodiment the invention is characterized in that said article is made of a polymer foam.

According to an embodiment the invention is characterized in that the polymer foam is an open-cell foam.

According to another embodiment the invention is characterized in that the polymer foam is a closed-cell foam with through holes.

According to a further embodiment the invention is characterized in that said polymer foam is a polyurethane foam, a polyester foam, a polyether foam or a polyvinyl alcohol foam.

According to another embodiment the invention is characterized in that the polymer foam is hydrophobic.

According to another embodiment the invention is characterized in that the polymer foam is hydrophilic or treated with an agent that makes the foam hydrophilic.

According to an embodiment the invention is characterized in that the chosen colour in the dry state has the following mean values

a lightness factor L* along the black-white axis of between 30-45 according to Test Method T-397,
a chromatic coordinate a* of between −40 to −25 according to Test Method T-397, and
a chromatic coordinate b* of between −3.5 to −1.5 according to Test Method T-397.

In an apparatus for treating wound with negative pressure, which apparatus including a pump for providing said negative pressure to the wound, a wound filler and a sealing film the invention is characterized in that said wound filler is made of a material in a chosen colour, in that said chosen colour is green and in dry state has the following mean values

a lightness factor L* along the black-white axis of between 20-55 according to Test Method T-397,
a chromatic coordinate a* along the red-green axis of between −45 to −20 according to Test Method T-397, and
a chromatic coordinate b* along the yellow-blue axis of between −4.0 to −1.0 according to Test Method T-397.

DETAILED DESCRIPTION OF THE INVENTION

The invention will in the following be described in connection with an embodiment where the article is polymer foam for use as a wound filling material. Polymer foam is often used as wound filling material in apparatus for negative pressure treatment of wounds.

When choosing colour of polymer foam for use in the wound area a lot of criteria must be fulfilled for optimal function of the polymer foam as wound filler.

The colour should preferably be in sharp contrast to other material used in the wound area and it should also distinguish from blood when used in a surrounding with heavy blood flow. That is, as mentioned above, a problem with white foam. A further drawback with white foam is that it has a tendency to become yellowish during storage and therefore get an unattractive look.

The problem with black colour of the foam is, as mentioned above, that a user or a caretaker, such as a nurse, will not be able to see when blood or pus is present in the foam. It is obvious that this in certain situations can be a serious disadvantage.

Blue foam has a tendency to fade during storage and therefore get an unattractive look. A drawback with blue foam is also that it will not give a satisfactory contrast to the wound.

We have also found that grey foam has serious drawbacks. Similar to white foam it will not distinguish from blood when wetted with blood and there is a risk that it after use will be left behind in the wound.

We have found that green colour stands out in clear contrast against body tissue and body fluids and is a colour that people feel positive to.

The foam in accordance with the described embodiment of the present invention is coloured in a chosen colour that stands out in clear contrast against body tissue and body fluids, such as pus and blood, and that hide the colour of body fluids present in the foam and make the presence of body fluids visible through a differentiation in the chosen colour of the foam, which differentiation occur when the foam in the chosen colour has taken up body fluids, such as pus and/or blood

We have further found that an optimal function of the appearance of polymer foam in dry as well as wet condition, i.e. wetted with blood or pus, is achieved when the chosen colour is green and when the green polymer foam in dry state has the following mean values

a lightness factor L* along the black-white axis of between 20-55 according to Test Method T-397,
a chromatic coordinate a* along the red-green axis of between −45 to −20 according to Test Method T-397, and
a chromatic coordinate b* along the yellow-blue axis of between −4.0 to −1.0 according to Test Method T-397.

Said method is in accordance with ASTM D 2244-07. The Test Method T-397 makes the measurements according to ASTM D 2244-07 more clear to perform. The Test Method T-397 is described in the enclosed Appendix I.

All measurements according to said method and described below have been made against a white background.

For use in negative pressure treatment of wound the foam is preferably reticulated, i.e. to make a more open cell structure. In negative pressure treatment the foam should promote granulation and allow removal of exudates through the foam. Negative pressure treatment is today a well established method for treatment of difficult and with earlier conventional methods slow-healing wounds. A description of negative pressure treatment can be found in for instance EP 0620720.

An example of a suitable material for the present invention is green polyurethane foam made of polyester polyol with physical characteristics with regards to pore size, tensile strength, hardness and density as the above mentioned GranuFoam.

The foam may be arranged in form of a body of planar form of a certain thickness, such as from 5-30 mm, which body during use is cut in accordance with the size of the wound to be treated. Other arrangement is of course possible. For instance the polymer foam may be arranged in form of small balls preferably interconnected with a common string, i.e. as a string of pearls.

Measurements have been performed to determine the absolute colour according to said method T-397 for the above mentioned material as shown in Table 1 below.

Table 1 shows the result for three different batches of green foam material and measurements were performed for two of the batches for non-sterilized and for sterilized foam.

Table 2 below shows for comparison the measurements for blue foam, white foam, black foam, grey foam and for green foam, i.e. green foam in accordance with the invention. Table 2 just shows results for non-sterilized samples in dry state.

Table 3 shows corresponding measurements as in table 2 but for wetted foams, i.e. wetted with synthetic blood and then drained and gently squeezed.

In addition to the test results we have found through visual observation that the presence of blood is clearly visible through a differentiation in the chosen green colour. The green colour darkens when the dry foam is wetted with blood. In wet condition the green foam is darker but it still glimmers in green colour. The presence of blood or pus is clearly indicated by said change in colour differentiation but at the same time the colour of blood and/or pus is hidden.

In contrast one can observe that the white foam is coloured as blood when wetted in blood. This is also the case for grey foam. Blue foam has a tendency to become reddish when wetted with blood and there is a risk that the blue foam when wetted with blood is left behind in a wound.

In contrast to the green foam in accordance with the present invention one cannot see when black foam has been wetted with blood. It is still black without a clear distinction from the dry black foam.

TABLE 1

Std.

Std.

Std.

Material
Sterile
L*
Dev
a*
Dev
b*
Dev

091808-
No
36.4
0.7
−31.0
0.5
−2.8
0.1

5B

091808-
Yes
35.1
1.1
−29.7
1.0
−2.5
0.1

5B

092626
No
35.0
1.1
−29.3
0.7
−3.0
0.1

092626
Yes
40.1
2.1
−33.5
1.2
−2.5
0.2

092759
No
32.1
1.4
−27.5
1.0
−3.0
0.1

In the column “Material” in table 1 the different batch numbers for the tested samples are mentioned for said foam material, i.e. polyurethane foam made of polyester polyol, as mentioned above.

The mean values for L*, a* and b* as well as standard deviation for the different batch are given in Table 1 above.

The absolute colour for the green foam according to the invention could be chosen within the limits of:

a lightness factor L* along the black-white axis of between 20-55 according to test method T-397,
a chromatic coordinate a* along the red-green axis between −45 to −20 according to test method T-397, and
a chromatic coordinate b* along the yellow-blue axis of between −4.0 to −1.0 according to test method T-397.

More specifically table 1 indicates that the chosen colour in the dry state has

a lightness factor L* along the black-white axis of between 30-45 according to Test Method T-397,
a chromatic coordinate a* of between −40 to −25 according to Test Method T-397, and
a chromatic coordinate b* of between −3.5 to −1.5 according to Test Method T-397.

TABLE 2

Type of foam
L*
a*
b*

Green foam
Mean
35.00
−29.30
−3.00

Std Dev
1.10
0.70
0.10

White foam
Mean
58.82
0.06
6.02

Std Dev
2.31
0.15
0.37

Black foam
Mean
20.11
0.08
−0.30

Std Dev
1.10
0.08
0.06

Blue foam
Mean
44.71
−7.74
−27.03

Std Dev
1.90
0.58
1.56

Grey foam
Mean
55.66
−0.32
1.65

Std Dev
1.09
0.07
0.40

TABLE 3

Type of foam + synthetic blood
L*
a*
b*

Green foam + synthetic blood

Mean value
17.51
−1.36
−1.17

Std dev
2.73
2.29
0.47

Black foam + synthetic blood

Mean value
17.91
4.01
1.12

Std dev
1.82
0.89
0.37

White foam + synthetic blood

Mean value
26.50
27.39
9.50

Std dev
2.36
2.64
1.52

Blue foam + synthetic blood

Mean value
26.61
5.97
−6.98

Std dev
3.05
2.32
2.64

Grey foam + synthetic blood

Mean value
31.16
22.90
5.39

Std dev
2.58
2.71
1.30

From table 2 above it is clear that only the green foam fulfils the characteristic features of the shade of colour according to the present invention.

As mentioned above only the chosen green foam works satisfactory in all respects.

In order to illustrate that it is not enough to just choose a green colour twelve different shades of green colour of green polymer foam have been tested. Said twelve different shades go from light green, shade No. 1, towards darker and darker green up to shade 12.

TABLE 4

Shade No. 1

Measurement
L*
a*
b*

Dry

1
80.05
−9.42
0.85

2
79.63
−9.48
0.68

3
78.47
−9.45
0.76

Mean value
79.38
−9.45
0.76

Std dev.
0.82
0.03
0.09

Wetted with

synthetic blood

1
30.43
34.85
11.32

2
27.52
34.30
10.37

3
31.70
35.94
12.34

Mean value
29.88
35.03
11.34

Std. dev.
2.14
0.83
0.99

Shade No. 2

Measurement
L*
a*
b*

Dry

1
76.70
−17.21
−2.37

2
76.47
−17.25
−2.33

3
76.11
−17.35
−2.52

Mean value
76.43
−17.27
−2.41

Std. dev.
0.30
0.07
0.10

Wetted with

synthetic blood

1
34.42
27.34
9.03

2
31.12
28.64
9.48

3
33.74
26.78
8.55

Mean value
33.09
27.59
9.02

Std. dev.
1.74
0.95
0.47

Shade No. 3

Measurement
L*
a*
b*

Dry

1
71.05
−25.55
−3.20

2
71.35
−25.72
−3.39

3
71.59
−25.75
−3.33

Mean value
71.33
−25.67
−3.31

Std. dev.
0.27
0.11
0.10

Wetted with

synthetic blood

1
27.49
24.04
7.69

2
23.53
23.74
6.94

3
27.08
23.30
6.92

Mean value
26.03
23.69
7.18

Std. dev.
2.18
0.37
0.44

Shade No. 4

Measurement
L*
a*
b*

Dry

1
71.27
−26.52
−2.19

2
72.02
−27.16
−2.54

3
71.09
−26.58
−2.69

Mean value
71.46
−26.75
−2.47

Std. dev.
0.49
0.35
0.26

Wetted with

synthetic blood

1
28.14
23.88
7.74

2
29.65
19.96
6.46

3
26.87
21.62
6.18

Mean value
28.22
21.82
6.79

Std. dev.
1.39
1.97
0.83

Shade No. 5

Measurement
L*
a*
b*

Dry

1
71.00
−29.21
−3.36

2
71.97
−28.80
−3.19

3
71.68
−29.71
−3.34

Mean value
71.55
−29.24
−3.30

Std. dev.
0.50
0.46
0.09

Wetted with

synthetic blood

1
30.55
20.06
6.57

2
25.14
22.77
6.81

3
28.10
19.83
5.94

Mean value
27.93
20.89
6.44

Std. dev.
2.71
1.64
0.45

Shade No. 6

Measurement
L*
a*
b*

Dry

1
67.33
−34.21
−2.93

2
67.90
−33.38
−3.47

3
67.70
−33.40
−3.51

Mean value
67.64
−33.66
−3.30

Std. dev.
0.29
0.47
0.32

Wetted with

synthetic blood

1
27.02
16.76
4.99

2
29.15
15.25
4.76

3
26.22
18.07
5.16

Mean value
27.46
16.69
4.97

Std. dev.
1.51
1.41
0.20

Shade No. 7

Measurement
L*
a*
b*

Dry

1
65.95
−35.21
−3.51

2
66.16
−35.54
−3.57

3
65.69
−35.27
−3.55

Mean value
65.93
−35.34
−3.54

Std. dev.
0.24
0.18
0.03

Wetted with

synthetic blood

1
22.87
16.23
4.85

2
22.54
16.64
4.43

3
24.08
16.09
4.59

Mean value
23.16
16.32
4.62

Std. dev.
0.81
0.29
0.21

Shade No. 8

Measurement
L*
a*
b*

Dry

1
65.35
−36.63
−3.05

2
63.83
−36.86
−3.34

3
64.37
−36.55
−3.38

Mean value
64.52
−36.68
−3.26

Std. dev.
0.77
0.16
0.18

Wetted with

synthetic blood

1
22.75
15.26
4.33

2
22.34
15.16
4.00

3
21.80
16.47
4.64

Mean value
22.30
15.63
4.32

Std. dev.
0.48
0.73
0.32

Shade No. 9

Measurement
L*
a*
b*

Dry

1
62.97
−37.99
−3.41

2
63.06
−37.64
−3.53

3
63.33
−38.79
−3.49

Mean value
63.12
−38.14
−3.48

Std. dev.
0.19
0.59
0.06

Wetted with

synthetic blood

1
22.34
12.11
2.69

2
24.20
12.76
3.55

3
24.28
12.39
3.27

Mean value
23.61
12.42
3.17

Std. dev.
1.10
0.33
0.44

Shade No. 10

Measurement
L*
a*
b*

Dry

1
62.24
−38.99
−3.24

2
61.39
−38.74
−3.50

3
60.15
−40.09
−3.54

Mean value
61.26
−39.27
−3.43

Std. dev.
1.05
0.72
0.16

Wetted with

synthetic blood

1
27.15
7.17
1.82

2
19.86
12.28
2.74

3
24.50
9.47
2.35

Mean value
23.84
9.64
2.30

Std. dev.
3.69
2.56
0.46

Shade No. 11

Measurement
L*
a*
b*

Dry

1
58.47
−40.59
−3.39

2
59.73
−41.81
−3.35

3
60.27
−40.10
−3.30

Mean value
59.49
−40.83
−3.35

Std. dev.
0.92
0.88
0.05

Wetted with

synthetic blood

1
21.88
6.20
1.35

2
20.78
7.90
1.61

3
24.23
6.86
1.53

Mean value
22.30
6.99
1.50

Std. dev.
1.76
0.86
0.13

Shade No. 12

Measurement
L*
a*
b*

Dry

1
51.51
−41.42
−3.22

2
53.68
−40.45
−3.05

3
51.10
−42.20
−3.21

Mean value
52.10
−41.36
−3.16

Std. dev.
1.39
0.88
0.10

Wetted with

synthetic blood

1
21.51
2.32
0.07

2
20.51
4.30
0.32

3
19.63
3.15
0.09

Mean value
20.55
3.26
0.16

Std. dev.
0.94
0.99
0.14

The results of the measurements shown in table 4 above have been achieved with a slightly modified version of the test method defined in Appendix 1. The only difference is that the number of samples is three instead of five as stipulated by said test method.

The results in table 4 above shows that only shade 12 fulfil the characteristic features of the present invention. It was observed that the colour of shade 12 when wetted with synthetic blood did not change to red. Instead the colour changed to a darker shade which still clearly glimmered in green. The green shade No. 12 will therefore be visible also in a bleeding wound. It was observed that the shades 1-11 when wetted with synthetic blood were coloured red. The shade of the red colour darkens more and more from shade 1 to 11.

The test results shown in table 4 above are for different shades of colour of dense (closed) polymer foam. The twelve tested samples were non-reticulated polyester based PUR foam. All samples had a size of 10×10 cm. The thickness was about 2 cm.

Further tests have been performed with different grades of green colour for open reticulated foam. Two different shades of green open reticulated foam have been tested.

One of the foam is light green, open reticulated polyether based PUR foam. Said open foam had a thickness of 3 cm.

The other foam is also open reticulated polyester based PUR foam but with a darker shade of green. The thickness of the tested sample of this open foam was also about 3 cm.

TABLE 5

Open reticulated-foam, light green

Dry

Measurement
L*
a*
b*

1
35.08
−23.85
4.55

2
35.00
−24.04
4.65

3
32.99
−22.42
6.26

4
36.08
−24.62
4.08

5
34.28
−24.08
5.47

Mean value
34.69
−23.80
5.00

Std. dev.
1.14
0.82
0.86

It is clear from the measurement results that this shade of open reticulated green foam does not fulfil the characteristic features of the present invention.

TABLE 6

Open reticulated foam, light green

Wetted with synthetic blood

Measurement
L*
a*
b*

1
14.44
5.10
1.84

2
15.92
3.13
1.55

3
16.21
2.78
2.17

4
16.18
1.99
1.06

5
15.28
3.81
1.76

Mean value
15.61
3.36
1.68

Std. dev.
0.75
1.17
0.41

It was observed that the colour of the foam when wetted with synthetic blood changed from green to red.

TABLE 7

Open reticulated foam, darker shade of green

Dry

Measurement
L*
a*
b*

1
32.94
−28.06
−2.29

2
32.89
−28.07
−2.27

3
34.72
−30.18
−2.39

4
31.84
−26.90
−2.28

5
32.35
−29.05
−2.20

Mean value
32.95
−28.45
−2.29

Std. dev.
1.09
1.23
0.07

It is clear from table 6 above that the open reticulated green foam of a darker shade of green compared with the light green foam fulfils all the characteristic features of the claimed invention.

TABLE 8

Open reticulated foam, darker shade of green

Wetted with synthetic blood

Measurement
L*
a*
b*

1
12.82
1.01
−0.74

2
14.88
−1.05
−1.68

3
13.92
0.59
−0.91

4
15.27
−0.93
−1.23

5
15.83
−1.89
−1.44

Mean value
14.54
−0.45
−1.20

Std. dev.
1.19
1.21
0.38

It was observed that the colour of the foam, which in dry state has darker shade of green, when wetted with synthetic blood did not change to red. Instead the colour changed to a darker shade which still clearly glimmered in green. The green foam with darker shade of green will therefore be visible also in a bleeding wound.

In contrast the green foam with the test result as stated in table 5 and 6 above will not when wetted with blood be visible in a bleeding wound.

The tests described above have been performed with articles made of polymer foam. The present invention is however not limited to polymer foam.

The important features are that the colour of the material is green and that the chosen colour is defined as set forth in the following claims.

The present invention covers all materials that are used in and around a wound.

Examples of materials are:

non-woven,
a netting material, for instance as defined in EP 0261167 A1 or
cotton, such as gauze.

All of said materials can be used as wound dressing or as wound filling material for instance in connection with negative pressure treatment.

On the market exists green ribbon gauze with the trade name Sorbact Ribbon Gauze. Measurements according to Test Method T-397 have been performed for dry Sorbact Ribbon Gauze. The results are shown in table 9 below.

Measurements according to Test Method T-397 have also been performed for Sorbact Ribbon Gauze after wetting the gauze in synthetic blood. The results are shown in table 10 below.

On the market exists green compress with the trade name Sorbact Compress. Measurements according to Test Method T-397 have been performed for dry Sorbact Compress. The results are shown in table 11 below.

Measurements according to Test Method T-397 have also been performed for Sorbact Compress after wetting the gauze in synthetic blood. The results are shown in table 12 below.

TABLE 9

Sorbact ribbon gauze (single layer)

Dry

Measurement
L*
a*
b*

1
73.85
−28.03
−4.40

2
72.72
−28.86
−4.48

3
71.85
−30.28
−4.54

4
71.62
−30.04
−4.58

5
70.21
−32.16
−4.32

Mean value
72.05
−29.87
−4.46

Std. dev.
1.35
1.57
0.11

It is clear from the measurement results that this green gauze does not fulfil the characteristic features of the present invention.

TABLE 10

Sorbact ribbon gauze (single layer)

Wetted with synthetic blood

Measurement
L*
a*
b*

1
41.24
18.04
4.42

2
34.79
20.98
5.86

3
34.10
21.70
6.20

4
36.76
20.94
5.92

5
38.77
20.23
5.28

Mean value
37.13
20.38
5.54

Std. dev.
2.93
1.41
0.71

It was observed that the colour of the green gauze when wetted with synthetic blood changed from green to red. The gauze when wetted with blood will not be visible in a bleeding wound.

TABLE 11

Sorbact compress (single layer)

Dry

Measurement
L*
a*
b*

1
80.32
−18.68
−2.05

2
80.34
−18.32
−2.22

3
80.12
−18.14
−2.23

4
80.44
−18.09
−2.24

5
80.95
−17.54
−2.09

Mean value
80.43
−18.15
−2.17

Std. dev.
0.31
0.41
0.09

It is clear from the measurement results that this green compress does not fulfil the characteristic features of the present invention.

TABLE 12

Sorbact compress (single layer)

Wetted with synthetic blood

Measurement
L*
a*
b*

1
47.65
15.31
4.90

2
48.98
14.28
4.34

3
56.66
10.57
2.55

4
50.48
13.40
4.09

5
54.22
11.45
3.12

Mean value
51.60
13.00
3.80

Std. dev.
3.75
1.96
0.95

It was observed that the colour of the green gauze when wetted with synthetic blood changed from green to red. The green gauze when wetted with blood will not be visible in a bleeding wound.

The test results on tables 9-12 confirm that it is not enough to choose a green colour to achieve the benefits of the present invention. One also has to choose shade of green colour as defined according to the present invention.

The article according to the invention is not limited to be used as a wound filling material. The invention covers all type of medical articles that are applied in, over and around a wound.

APPENDIX 1
Test Method T-397
Determination of Colour and Opacity
1 Reference Method

ASTM D 2244-07

2 Purpose

To determine absolute colour and/or opacity

3 Field of Application

All kind of materials

4 Definitions

The result for colour measurement reported according to L*a*b* colour system

(CIE 1976) where:

- L*=lightness factor, black-white axis (0 black/100 white)
- a*=chromatic coordinate, red-green axis (+ red/− green)
- b*=chromatic coordinate, yellow-blue axis (+ yellow/− blue)

The result for opacity is reported according to the Y-x-y colour system (CIE 1931) where:

- Y=% light reflectance
- x and y=chromaticity coordinates

5 Principle

Illumination is provided by a pulsed lamp (CIE Illuminent D 65). The light illuminates the sample to be measured and reflects on to the photocells which convert the light into chromatic and lightness data.

6 Preparation of Test Pieces

- Material required—At least 10×10 cm of sample material or 5 whole products
- Number of measurements 5
- Preparation Not applicable
- Conditioning Not applicable—but important that both the calibration and the measurements are done in the same climate condition.

7 Equipment

Minolta Chroma Meter CR 300

For opacity measurements, at least five sheets of respectively; black printing paper and white copy paper

8 Procedure

Calibrate the instrument according to Calibration Instruction and make sure you handle the instrument correctly.

Calibration Instruction:

- 1. Press Calibrate. Wait for about 5 seconds until “Set Cal data display→Measure” has changed to “CAL ch00Y-x-y” (calibrating channel 00). If the displayed colour space is not Y-x-y, press Colour Space Select repeatedly until that is the case. See that the displayed numbers for Y-x-y correspond to the listed data inside the cover of the white calibration plate. If not—see the instruction manual!
- 2. Place tip of measuring head flat at the center of the white calibration plate. Press Measure or measuring head's measuring button after ready lamp on measuring head lights. Three measurements will automatically be taken and do not move the measuring head until the measurements are ready.
- 3. After about 5 seconds “CAL” will be replaced by “END” in the display.
- Calibration is now complete.

Colour Measurement:

- 1. Press Colour Space Select repeatedly until L*a*b*-space is displayed.
- 2. Place tip of the measuring head flat to the surface of the sample and press Measure or press the button of the measuring head after ready lamp on measuring head is lit.
- 3. Carry out 5 approved measurements on each sample.
- 4. Press the Statistic button followed by Enter to receive the mean and the standard deviation.
- 5. Choose a new page for the next sample by pressing the Page button followed by Enter.
- 6. Repeat step 2-5 for the next sample.

Opacity:

- 1. Press Colour Space Select repeatedly until Y-x-y-space is displayed.
- 2. To obtain an opacity number, two different measurements will have to be conducted. One with the specimens on top of a black surface (or right in the air), to get the Y_black, and one on top of a white surface, to get the Y_white.
- 3. First, carry out 5 measurements of the sample placed on top of a black surface (five sheets of black printing paper) and then press the Statistic button followed by Enter to receive the mean and the standard deviation for Y_black.
- 4. Thereafter, carry out 5 measurements at the same spots of the sample, as before, but placed on top of a white surface (five sheets of white copy paper) and then press the Statistic button followed by Enter to receive the mean and the standard deviation for Y_white.
- Note; Make sure that the corresponding are made on Y_blackand Y_whitethe same spot of the sample.
- 5. Choose a new page for the following sample by pressing the Page button followed by Enter.
- 6. Repeat step 2-5 for the next sample.

9 Calculations

Opacity number:

O=Y
_black
/Y
_white*100

10 Reporting

Method and if any deviations

Material and origin

Sample designation

Number of measurements

Mean value and standard deviation of L*, a* and b* for colour measurements

Mean value and standard deviation of Y_blackand Y_whiteand the opacity number, O, for opacity measurements

GREEN ARTICLE FOR USE IN WOUND TREATMENT

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