CA1156555A - Preparation for the treatment of wounds, sores, ulcerations and other exudative skin affections - Google Patents

Preparation for the treatment of wounds, sores, ulcerations and other exudative skin affections

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Publication number
CA1156555A
CA1156555A CA000362637A CA362637A CA1156555A CA 1156555 A CA1156555 A CA 1156555A CA 000362637 A CA000362637 A CA 000362637A CA 362637 A CA362637 A CA 362637A CA 1156555 A CA1156555 A CA 1156555A
Authority
CA
Canada
Prior art keywords
preparation
wounds
skin
sores
ulcerations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000362637A
Other languages
French (fr)
Inventor
Franco De Marchi
Gioacchino Cipriani
Vincenzo Foti
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Anic SpA
Original Assignee
Anic SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Anic SpA filed Critical Anic SpA
Application granted granted Critical
Publication of CA1156555A publication Critical patent/CA1156555A/en
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/44Medicaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2203/00Applications
    • C08L2203/12Applications used for fibers
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04Homopolymers or copolymers of ethene
    • C08L23/06Polyethene

Abstract

PREPARATION FOR THE TREATMENT OF WOUNDS, SORES, ULCERATIONS AND OTHER EXUDATIVE SKIN AFFECTIONS.

ABSTRACT OF THE DISCLOSURE . -A preparation is disclosed for the treatment of wounds, sores, ulcerations and other exudative affect-ions of the skin, which is composed by microfibrous materials, based on synthetic polymers, and having a very high specific superficial area, over 30 square metres per gram, and very tiny size, the diameter lying in the range from 2 to 10 microns and the length in the range from 1 to 5 mm: high-density polyethylene is a preferred material.

Description

This invention relates to-a novel preparatio~ for the treatment of wounds, sores, ulcerations of the skin and any other skin affection which, like the ones just named, pro-duces discharge fluids (exudates).
In particular, the present invention provides a pre-paration consisting essentially of microfibres of a synthetic polymer having a surface area of more than about 30 m ~g, a diameter of about 2 to about 10 microns and a lenyth of about 1 to 5 mm, and a carrier therefor suitable for topical treatment of wounds, sores, ulcerations and other exudayive skin affec-tions.
In accordance with the present invention the polymer may be selected from the group of polymers consisting of poly-ethylene, polypropylene, polystyrene and olefinic copolymers.
As indicated above, the novel preparation comprises micro-fibrous materials, which are obtained from synthetic polymers and have quite particular shapes. They are adapted to the absorption of the exudates from the surfaces treated there-with and to the constant maintenance of healthy, oxygen-rich and balanced constant humidity environment such as to encourage the occurrence and the persistence of the consitions which are most appropriate for reinstating the physiological skin functions.
In addition, the subject preparation does not permit that a crust may be formed directly on the skin surface which has been damaged, but, rather, at a certain distance from the skin: this circumstance prevents the formation of a barrier-layer susceptible of barring the exit, from the wound, of dust, bacteria, toxic degradation products or inflammatory agents, and so forth. Thus, the wound can be much more conveniently cleaned and its healing is thereby accelerated.

~ 1 -- .

C

1156~55 The microfibrous materials mentioned above have very reduced dimensions : the diameter is from 2 to 10 micron and the length varies from 1 to 5 millimetres ~mm): in addition they have a very wide specific sur-face area, the latter being over 30 square metres ~m2)per gram (g).
Such materials can be obtained by flash extru-sion, that is by extrusion through a no~zle from a pres-surized environment to an environment in which ambient pressure obtains, the pressure differential between the two environments being at least 30 atm. of solutions of polymers, or, better to speak, of homogeneous solutions of mixtures of polymers in appropriate proportions, such as, for example, has been disclosed in the Italian Patent Specification N 995 549 by the same Applicants.
In flashing a sudden evaporation occurs of the solvent, with the attendant formation of microfibers having a very tiny size.
In order that the healing of wounds, sores and ulcerations, especially of the purulent kind, may be achieved, it is essential to remove therefrom the exuda-tes that they discharge, as well as the pollutants which may induce infections, while concurrently maintaining a correct balance of humidity sc as to ensure a clean environment and such conditions as to encourage the ra-pid regencration of the skin cel~s.
Above all, it is vital, in suchcases, to prevent the formations of crusts due to the reticulation of ~ibrin, 115~5 - which adhere too closely to the wound surface and impede a regular exchange of moisture oetween the skin and the atmosphere, thus causing the stagnation of the exudates and the attendant formation of infectious pockets.
There is no concordance of opinions as to the possibility of accelerating the regeneration of skin tis-sues in the case of wounds, ulcerations and the like.
It is certain, however, that in the case of puru-lent or exudative affections, the removal of infected materials or of the possible infectious medium or agent capable of encouraging the formation of thick crusts encourages the regeneration of the cells and thus the healing of the inJured surface.
It has been suggested to treat wounds of exuda-tive affections of the skin with powders or dry powdered materials in minute particles, both of an inorganic or organic nature, possibly also based on polymers, but with little or no success at all.
It has also been suggested, this time with a certain success, to use macromolecular substances con-taining hydrophilic groups, in the form of a powder consisting of minute, virtually spherical, particles which absorb, presumably in a selective way, the fluids discharged from wounds or other skin alterations, as disclosed in the British Patent Specification 1 454 055.
It has now been ascertained, and this is the sub-~ect matter of the present invcntion, that the local application in the form of a dusting powder, occlusive 11~6555 pads, ointments, creams or other preparations based on microfibres of the kind referred to above has surpri-singly been conducive, both in the form of microfibres above and in combination with other medicaments, to a quick healing of the hurt skin surfaces.
In addition to absorbing and removing the noxious fluids, these microfibres seem to ensure a fully satis-factory transpiration of the underlying skin surface:
furthermore, the microfibres do not pack on the wounds and do not form any hard or sticking crusts, so that they can conveniently be withdrawn during progress of medica-tions without causing any additional damages to thc wounds, contrary to what occurs with the conventional wound dressing materials.
In order that the present invention may be better understood,a description will be given hereinafter of test runs carried out on rabbits on which purulent sores had been artificially induced, with a view to ascertain-ing the effect of the microfibres on wound healing, in com-parison with other commercial products intended for the same purposes Concurrently, tests have been conducted in compa-rison with rabbits having sores of the same kind refer-red to above, but without any application of skin wound healing products.
DESC~IPTION OF THE TESTS
Tests have been conducted on 18 white New Zealand rabbits. On all rabbits a sore of certain dimensions has artificially been induced. To this purpose, a skin strip of 8 by 8 centimetres has been removed surgically fr-om the back, with.anaesthesia. The exposed area was infected by spreading thereon an admixture of mouse and rabbit excrements, human pus and physiological solu-tion, the whole carefully homogeneized in a mortar, whereafter the wound so infected was covered with the overturned skin strip and with a moistened gauze.
After having maintained the thus treated skin portion in a moist and warm environement for four days, the wounds were infected by a mixed bacterial flora, mainly composed by Escherichia Coli, Proteus sp., Pseu-domonas Aeru~inosa, Staphylococcus Aureus and Beta-, . .
haemolytic Streptococcus.
.
Foreachrabbit the size and the exact countour of the wound was recorded on a X-ray plate, as follows:
after the four days as from the surgical removal and the application of infectous materials, the cover of skin and gauze was removed from all rabbits. All the loose dirt, crusts and pus were removed and the wounds were irrigated with 20 mls of physiological solution. An unexposed X-ray plàte was laid on the wound and the wound contour was exactly traced with a pen. An arrow was pla-ced in the direction of the head and the plate marked with the rabbit's name, so as to be able to place subsequent-ly the plate in the same position for each rabbit : thus the si~e of the wound was periodica~.ly.checked and the dateline inscri~ed.

11~6~5 6.

The marked plates, completed with all the records, served for the determination of the wound healing time.
The wounds were checked for a total time of about 23 days : as a matter of fact, this time is the period in which the maximum wound healing takes place, as had been ascertained on pilot tests on two control rabbits, even though the complete healing is experienced to re-quire 4-~ weeks.
The eighteen rabbits, the wounds of which had been cleaned as specified above, were divided into three groups of 8 rabbits each.
A first group (Group 1) was the control group.
The six control animals were left with their wounds expos-ed to air, without any medication at all. No wound dress-ings were applied in any case since this would promote,especially in rabbits, a too intensive purulence, even in aseptical conditions. The other two groups of six rab-bits each received a medication, as follows : the Group
2 was medicated with a macromolecular substance obtained by cross-linking of dextran or carboxymethyldextran with epichlorohydrin in the form of microspherical particles, the use of which for the dressing of exudative wounds is disclosed in the British Patent Specification 1 454 055 and which is marketed under the Trade Mark Debrisan. The Group 3 was treated with high-density polyethylene micro-fibres, as obtained according to the method of the Italian Patent Specification N 995 549 and having, as an average, a diameter of from 5 to 10 microns, a length of from 1.4 5~5 7, to 1.6 mm, and a specific surface area of about 40 m2lg.
The medication consisted in laying on the wounds a layer of material: every third day the wounds were checked and the debris removed and the applied mate-rial withdrawn . the wound contour was traced on the respective plates.
Each rabbit then received the medication treat-ment exactly as before.
In order to be enabled to give a numerical evalua-tion of the wound healing, the following method has been adopted.
On completion of the test period, each plate car-ried drawn thereon a set of approximately circular, con-centrical curves.
- 15 On each plate, à cross wasdrawn in such a position that the intersection of the CrQss-arms fell approximate-ly upon the centre of the circumferences. The ends of the cross-arms were oriented in the positions of 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock.
As the baseline the initial tracing of the wound at the time of surgical skin removal was taken. Also the last reading, that is the one corresponding to the healing of the wound, was recorded.
The distance in millimetres (mm) between the base-line and the ultimate tracing was measured along each cross-arm (in the order 3, 6, 9, 12). The sum of these distances, divided by four , gave the average length of healed wound for each rabbit. The wound healing velocity 11~8555 was calculated by dividing the averaye length of healed wound by the number of days requlred in total for the healing of the wounds.
- TABLE 1 records the values relative to the heal-ing of wounds of each animal of each group.
Subsequently, the average of the healing of wounds was calculated for each group of rabbits, while concurrently evaluating the average testing time for each group by summing the healing velocity of the rabbits of each group and dividing this sum by 6.
One of the rabbits which had been treated with Debrisan (Trade Mark) has given an anomalous-response -~ to the treatment because, at the end of the period of time by which all the other rabbits had their wounds hea-led, exhibits a pus pocket and itc wound did not heal.
The values of this second evaluation are tabulated in TABLE 2.
It is apparent from the mere reading of the TABLES
that the rabbits of Group 3 has exhibited an improved total (i.e. group) and average wound-healing velocity (see particularly TABLE 2).
Moreover, the following observations have been made on the behaviour of the wounds treated in different ways in thc three groups of rabbits.

For the Group 1 the formation of a thick crust, rather difficult to clean, has been noted. A portion of the crust was so sticking that it cannot be removed with-out damaying the wound and causing pains to the animal.

9.

The same problems have been experienced for the rabbits of the Group 2: in this case, furthermore, a few difficulties were experienced in trying to have the Debrisan staying on the woùnd, on account of the exceed-ingly high free-flowing property of the product, so that the wound was left partially exposed.
For Group 3 the formation of a thick~ but light crust was experienced, but the crust was not pasty on the wound surface-and could easily be peeled off so that it was easy to clean the wound quickly.
In addition, the application of the microfibrous materials to the wounds did actuàlly proved convenient since, due to its soft texture, it stayed easily on the spot but without pasting.

TABLE

~ 1~6555 10 - .
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Z ~ ~ ~ O 1`--I ~ I~ ~1 ;~ U~ 0 Ir~
H 1~ ...... ...... ......
~ O O--I ~ O .--1 _I O ~ 0 -1 LLI E
.

LL~ cn C U~ ~ U~ o U~ U~ o U~ o U~
1 E ~J 1` ~`J t`J r_ o ~ <~ o t~ o t~--I E ...... ...... ......
LL.I 1~1 ~ ~ O~ i ~ 0 r ` ~ 0 0 ~: ~ . ' o u~ ~ O ~ ~ ;~ O ~O ~ ~ U~ O
Z E~ t~ ~`J~ ~ ~ ~`I ~ rr~ ~ ;1- tr~ ~ ;i ~ Ir~
_~ .
'~O .
llJ ~
Z Etr~ ~ ~ ~ ;t ~ 0 r~ U~ 1~ 0 ~J ~ 0 0 LLI H E I
J
m ~
~1: I~J 0 o ~ ~ ~ o ~ o u~
I_ ~ EE (r~
.
_, LIJ E ~ ~ O O~ O O 1~ ~ ~ O--Z E

O ;l' ;t ;t ;t ~1 N ~ ;~' ~t N ~J ;t U~
Z

~o .-- ~ J ~ ~ N ~ ~ ~ r~

U~ LL~
~) JZ C~ ~ H
l_ hJ L~ H Z H 0::
~cC C ~ ~ mz ~n o ~ o ~ ~ H
m C) Z ~ J ~ LLI ClH H C~ O ~ z 1 tC3 E o LLJ ~ LL.I Z ZL~ J C~ Z C~ Z 1 d t~) tt ~ O ~ ~ ZL~ J O O ~ I LLJ O O ~ C LL~
_ - . .

11~6~5 GROUP_ 1 Total Group Healing velocity 6.935 mm/day (6 animals) Average Healing velocity 1.155 mmlday/animal Average number of days 23~ 35 GROUP _2 Total Group Healing velocity 6,140 mm/day (6 animals) Average Healing velocity 1.023 mm/day/animal Average number of days 23, 33 Total Group Healing velocity 8.435 mm/day (6 animals) Average Healing velocity 1.405 mm/day/animal Average number of days 23, 00

Claims (6)

The embodiments of the invention in which an exclusive property or privilege is claimed, are defined as follows:
1. A preparation consisting essentially of micro-fibres of a synthetic polymer having a surface area of more than about 30 m2/g , a diameter of about 2 to 10 microns and a length of about 1 to about 5 mm, and a carrier therefor suitable for topical treatment of wounds sores, ulcerations and other exudative skin affections.
2. A preparation as defined in claim 1 wherein said microfibres are presented in an amount sufficient to absorb and remove exudates from the skin, while neither packing on the skin affections nor forming any hard or sticky crusts.
3. A preparation as defined in claim 1, wherein the carrier is selected from the group consisting of dusting powders,occlusive pads, ointments or creams.
4. A preparation as defined in claim 1, further including a curative substance.
5. A preparation as defined in claim 1 wherein the polymer is a high density polyethylene.
6. A preparation as defined in claim 1 wherein the polymer is selected from the group of polymers consisting of polyethylene, polypropylene, polystyrene and olefinic copo-lymers.
CA000362637A 1979-10-18 1980-10-17 Preparation for the treatment of wounds, sores, ulcerations and other exudative skin affections Expired CA1156555A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT26577/79A IT1125491B (en) 1979-10-18 1979-10-18 PREPARED FOR THE TREATMENT OF WOUNDS, SORES, ULCERATIONS AND OTHER EXUDATIVE SKIN AFFECTIONS
IT26577A/79 1979-10-18

Publications (1)

Publication Number Publication Date
CA1156555A true CA1156555A (en) 1983-11-08

Family

ID=11219819

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000362637A Expired CA1156555A (en) 1979-10-18 1980-10-17 Preparation for the treatment of wounds, sores, ulcerations and other exudative skin affections

Country Status (15)

Country Link
JP (1) JPS5666261A (en)
BE (1) BE885774A (en)
BR (1) BR8006651A (en)
CA (1) CA1156555A (en)
DE (1) DE3039288C2 (en)
DK (1) DK438880A (en)
FI (1) FI803165L (en)
FR (1) FR2467600A1 (en)
GB (1) GB2060381B (en)
IE (1) IE50324B1 (en)
IT (1) IT1125491B (en)
LU (1) LU82854A1 (en)
NL (1) NL8005773A (en)
NO (1) NO150706C (en)
SE (1) SE8007283L (en)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH365830A (en) * 1960-05-30 1962-11-30 Soc D Rech Scient Et D Exploit Non-stick dressing material
US3878138A (en) * 1972-10-30 1975-04-15 Warner Lambert Co Anhydrous products having improved wettability characteristics
SE452109B (en) * 1973-01-29 1987-11-16 Pharmacia Ab SCIENTIFIC CLEANER EXTENDED SARYTOR
IT995549B (en) * 1973-10-02 1975-11-20 Anic Spa PROCEDURE FOR THE PRODUCTION OF FIBROUS STRUCTURES
CA1113005A (en) * 1977-12-06 1981-11-24 Pierluigi Vanoni Excipient composition for creams

Also Published As

Publication number Publication date
FR2467600A1 (en) 1981-04-30
GB2060381B (en) 1984-01-25
BR8006651A (en) 1981-04-22
NO150706C (en) 1984-12-05
DK438880A (en) 1981-04-19
LU82854A1 (en) 1981-06-04
NL8005773A (en) 1981-04-22
IE50324B1 (en) 1986-04-02
DE3039288C2 (en) 1984-01-19
FR2467600B1 (en) 1983-06-10
NO803093L (en) 1981-04-21
SE8007283L (en) 1981-04-19
IE802082L (en) 1981-04-18
IT1125491B (en) 1986-05-14
FI803165L (en) 1981-04-19
BE885774A (en) 1981-04-17
IT7926577A0 (en) 1979-10-18
JPS5666261A (en) 1981-06-04
DE3039288A1 (en) 1981-04-30
NO150706B (en) 1984-08-27
GB2060381A (en) 1981-05-07

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