Evaluation of the curative effect of medical device
QuickSeal Bandage
The medical device QuickSeal Bandage is a covering dressing made of active
carbon textile for the treatment of crural ulcers, diabetic defects,decubitus, burn
wounds, impetiginised traumatic changes, infected operation wounds, secerning
infected wounds, excreting tumour defects, respectively other problems.
The covering dressing QuickSeal Bandage is absorbent, porous and permeable,
suitable for absorption of organic matters, microorganisms. toxins and unpleasant
odour. According to the producers ´s data it is a two-layer covering, while the top
layer is made of non-woven white textile made of mixture of viscose and
polypropylene fabric and forms an inactive vehicle of a black sorbent. The sorbent is
an elastic textile with a macroscopic smooth surface made of thermally processed
cellulose hydrate fabric. The result of the special technology, i.e. carbonisation and
activation under high temperatures is a textile made of active carbon textile of high
sorption capacity. The sorbent which gets to a close contact with the wound actively
intercepts microorganisms and chemical agents, prevents secondary infection, has
deodorant effects and significantly promotes healing of wounds. It is not toxic,
aggressive and has no allergenic effects.
The dressing is soft, flexible, malleable to unevenness of the skin surface. It is easily
applicable and removable, it causes no traumatic effects when the dressing is
changed. Those characteristics of the product and the suitable application form allow
its wide use for infected defects where it contributes to the cleaning of the wound
bottom, creating of adequately humid environment and promoting of the healing
process in all healing phases. Depending on the secretion intensity it can be left on
the wound for several days which reduces the number of necessary bandages and
the risk of nosocomical infection in hospitals. Thanks to the above mentioned
characteristics, especially thanks to the easy application, it can be used for
ambulatory treatment of chronic wounds.
At the dermatovenereological clinic of the teaching hospital in Brno-Bohunice, where
the Centre for Healing of Chronic Wounds is operated, we had a chance to verify the
presented effects of the presented effects of this covering dressing in the previous
years. The covering foil was used for varicose ulcers of venous origin, especially
post-thrombosis ulcers which did not heal in case of traditional ointment and
compress therapy. Varicose ulcers of venous origin show excessive exudate and
therefore the sorption effect of the dressing forms a condition for creating of
adequately humid environment. In those indications the use of the type Bandage
proved to be extraordinarily advantageous, almost all patients stated reduced pain,
elimination of odour that often prevented patients from normal social life was obvious.
After application of the dressing very fast cleaning of the defect bottom with start of
granulation was observed.
Conclusion:
Based on our experience and the relatively high number of patients we find the use
of device QuickSeal Bandage very good. Doctors, hospital staff and patients
appreciate mainly the easy application, elimination of the often unpleasant odour and
significant reduction of pain which contributes to a better quality of the patient ´s life.
The covering product contributes to cleaning of the wound and overall acceleration of
the healing process which is definitely also financially appraisable.
Brno, March 24, 2003
doc.MUDr. Pospíšilová Alena CSc
Head of dermatoveneorological clinic of FN Brno
Prof. dr. Ereckaja E.V., dr. Sachno L.A., dr.Vovjanko S.I., dr. Ulčenko
V.3.
Institute for oncological problems R.E. Kaveckého
Academy of Science of Ukraine, Kijev
Experimental justification of a timely use of applicable sorption
products from the active carbon during the healing of wounds.
The aim of this thesis was to prove the purpose and effectiveness of use of materials
from the active carbon textile in the initial phase of processes after the wound origin.
The use of applicable new absorption products during the healing of small-area
lesions which don ´t have to be treated operatively, just like some mechanisms of
sorption therapy of lesion.
The experimental determination was performed on the rabbit males chinchilla
weighing 1,5 – 2,5 kg. After a ten-day quarantine and laboratory examination under
the aseptic conditions and in narcosis (thiopental natrium 50 mg/kg intramuscularily)
two lesions on the surface of postlateral thighs were done to the animals, each with
the size of 11,57 +- 0,95 cm2. After the excision of skin lobe together with the
subcuticular base and femoral fascia and the diagonal interruption of sciatic muscle
by a wound deep 0,5 – 07cm, the wounds were covered up by the covering from
carbon absorbent
(subject of examination) or standard cotton gauze. After the
detection of time duration of bleeding and blood loss the covering were fixed by the
dressing. As an applicable sorption product the material from the active carbon textile
was used with the animals of test group. The wounds of control animals were
treated with the usual, standard gauze dressing.
The dressings were changed
during the first 5 days after the operation daily, afterward on 10 th, 14th, 17th and 21st
day. At the same time the animals were examined. The impact of applicable
absorption products was assessed according to the results of clinic observation of the
wound ´ s healing process and total condition of the animal, measurement of the
wound, biochemical and cytological examination and autopsy. The reliability of
examination results was verified by t- test.
Picture 1- Water contents in the lesion tissue during the lesion process
85
-
%
80
Test animals
Control animals
75
70
0
5
10
15
20
Days
When using the compression from active carbon fabrics the stopping of bleeding took
place after 72+-15 sec., during the treatment of wound by the classic gauze bandage
the bleeding took 390 +- 85 sec. The blood loss calculated as per the weight
increase of covering was with the test animals twice lower than with the control
animals: 2,1 +-0,2 g against 5,2 +- 0,3 g. After the correction of these values due
to higher hygroscopic properties of the material of active carbon fabrics the real blood
loss is still slighter.
Pic. 2 - Contents of malondialdehyde in the tissue of wound and blood serum
in the course of wound ´s healing.
a) in the tissue of wound
%
1500
1000
Control animals
Test animals
500
0
0
5
10
15
20
Days
b) in blood serum
nmol.g-1
600
400
Test animals
Control animals
200
0
Days
0
5
10
15
20
Malodialdehyd – one of the most important final products of peroxidation of lipides
(1)gathers in the tissue of wound of control animals in a considerably higher amount
than in tissue of wound of test animals . (pic. 2a). In the blood serum of both the
groups the changes of malodialdehyde contensts were not so significant (pic. 2b) but
the differences between both the groups, which were observed during 3 – 7 days,
were very big.
The property of material of active carbon fabrics to absorb a fluid quantity which is 512times higher than its own weight (according to activity and structure of material) is
an evident reason for the fact that there is practically no noticeable swelling of the
wound, covered up by the dressing of active carbon fabrics, as opposed to the
gauze dressing when the promotion of swelling came about already during the first
hours after the injury and it persisted for more than 5 days. The contents of water in
lesion ´s tissue was evaluated as per the difference of weight of tissue sample from
the wound and after its drying up at 105+-2 ° C in the course of 24 hours. It can be
admitted that the antiedemic effect of compressions from the active carbon fabrics
during the contact with the injured tissue is not conditioned by only and not so much
absorption of free fluid from the intercellular room but rather by a quick and
irreversible absorption of substances by which it increases the capillary permeability
and elevates the local osmotic pressure.
Due to the material of active carbon fabrics the elimination of mediators of the
inflammation should contribute to the weakening of inflammatory reaction, especially
significantly then in the first days after the injury. In the first three days of the lesion
´s course big differences were really detected with the animals of control and test
group. The body weight of control animals decreased after 24 hours by 14 +-3 %
and it adjusted again on 21.day. The rectal temperature of these animals decreased
by 1,0 – 1,2° C and normalized after 7 – 10 days. The animals of the control group
experienced a short-term lowering of rectal temperature after 24 hours not exceeding
0,5 – 0,6 ° C. The body weight of test animals remained unchanged during the whole
observation time period.
Pic. 3 - Contents of proteins in tissue of wound and blood serum in the course
of healing of the wound.
a) in tissue of wound
30
%
10
-10
0
5
10
-30
-50
Days
b) in blood serum
15
20
Test animals
Control animals
10
%
5
0
-5
0
5
10
15
20
Control animals
Test animals
-10
-15
-20
days
In the course of duration of the whole observation the protein content in the wound ´s
tissue of control animals decreased permanently which is proved by a clearly more
marked form of the disintegration process (pic. 3). With the control animals the
decrease of protein contents in the injured tissue in the first section of the injury
process was considerably lower than that of control animals, in the second section
this value became normal.
The index K, defined as the relation of optical density of proteinless filtrate of blood
serum at the wave lengths of 280 and 254 nm varies with the resoption of septical
substrates. Pic. 4 shows the change of index K depending on the condition of
wound healing of the test and control animals. The detected differences were
confirmed with the autopsy when the metastatic abscesses in liver and lungs were
proved with the most animals of control group. No evident symptoms of infection
were detected with the test animals.
Pic. 4 – Index K during the injury
0,6
K
0,5
Test animals
Control animals
0,4
0,3
0,2
0
5
10
15
20
days
The wounds treated by compression from the active carbon fabrics healed under the
developed scabs, as opposed against the control group where the secondary healing
of wound was observed. Under the artificial scab from the compressions from active
carbon fabrics the epitelisation was terminated without any complications after 18-21
days and under the similar course of local processes with all the control animals.
The velocity with which the injury area diminished on average with the test animals
was twice as large as that of control animals (pic. 5). The polymorphic course of
disease was observed with the control animals: from the complete healing of the
wound up to the development of suppuratively septic complications and lethal
termination (comp. Table).
Peculiarities of the injury course of rabbits
Frequency %
Test group
Control group
Values
Complete epitelisation of
wound after 21 days
Uncomplicated process of
injury
100
22,0
98,5
0
Complicated process of injury
1,5
100
Phlegmona of wound
0
33,8
Ulcers
0
67,7
1,5
40
Abscesses on liver and lungs
0
20,6
Lethality
0
33,8
Contractions
Pic. 5 - Results of wound measurement
14
cm2
12
10
8
Test animals
Control animals
6
4
2
0
1
6
11
16
21
days
An early usage of materials of the active carbon fabrics as the application on the
freshly operated, by extension on traumatic wounds supports a lowered intensity and
accelerated termination of inflammatory reactions. The application of absorptive
materials can be designated as a healing process with a small-area extent of lesion
and as a prophylaxis measure during the development and symptoms of wound
infection with the arbitrarily significant injuries.
May 2003
Prof. dr. Ereckaja E.V., dr. Sachno L.A., dr.Vovjanko S.I., dr. Ulčenko