Dressing device for treating chronic ulcerative lesions

Abstract

A device for dressing chronic ulcerative lesions, has a gauze (1) impregnated with an ointment, a support film (2), provided with a perimeter edge (20) free from the gauze (1), a covering film (3), and a bag container (4), provided with sealing flaps (40). The ointment with which the gauze (1) is impregnated is a 0.3% Tobramycin ointment.

Description

DescriptionTitle of Invention: DRESSING DEVICE FOR TREATING CHRONIC ULCERATIVE LESIONSField of the invention

[0001] The present invention concerns a dressing device for treating chronic ulcerative lesions.

[0002] Chronic ulcers, particularly those of the lower limbs, are a serious health problem.Prior art

[0003] Currently, there are numerous formulations of dressings on the market, but they are not able to bring about complete healing of chronic ulcerative lesions due to superinfection by bacteria resistant to antibiotics.

[0004] Identifying advanced dressings, which can control infections by resistant bacteria, represents a significant improvement in clinical practice, which, however, does not seem to have been achieved to date.

[0005] As reported in scientific literature and in antibiograms, ulcers that have been chronic for more than six months are almost always infected by the multi-resistant bacterium Pseudomonas aeruginosa. Given the multi-resistance, there are only a few antibiotics capable of effectively combating superinfection by Pseudomonas aeruginosa, and none of these antibiotics is indicated for skin applications. At present, therefore, there are no topical skin formulations suitable for the treatment of skin and vascular ulcers due to Pseudomonas aeruginosa.

[0006] The antibiotic Tobramycin is currently formulated as an eye drop or ophthalmic ointment for the treatment of infections and inflammations of the eye where the presence of Pseudomonas aeruginosa is found.

[0007] In the publication entitled “An Innovative Technique in Local Antibiotic Delivery Method in Open Infected Wounds of the Musculoskeletal System” by C. Shekhar, Apollo Hospital of Delhi, reported in Int J Low Extrem Wounds. 2019 Jun;18(2):153- 160. doi: 10.1177 / 1534734619841764. Epub May 8, 2019, the author states that he has treated difficult cases of infected wounds from road accidents, diabetic ulcerative lesions in diabetes mellitus with the application of Vitamin D3 granules impregnated with Tobramycin or Tobramycin and Vancomycin combined. The author states that all patients have responded successfully to this new method of treatment which is extremely simple, effective, low cost, without complications or side effects and has shown excellent results.

[0008] The publication “Use of antibiotic impregnated resorbable beads reduces pressure ulcer recurrence: A retrospective analysis” by Ibrahim Khansa et al states, among otherthings, that the bone culture results in many cases have shown a mixture of pathogens, the most common species being Staphylococcus, Streptococcus, Pseudomonas, Acinetobacter and Escherichia, all sensitive to Vancomycin and / or Tobramycin. The rate of recurrence of pressure ulcers one year after excision and engrafted skin coverage was significantly decreased with the use of the above-referenced antibiotic- impregnated absorbable beads.

[0009] US20090202609A1 describes a composition and method thereof for coating a surface with a bioactive agent, e.g., for coating the surface of an implantable medical device such that the surface releases the bioactive agent over time when implanted in vivo. In typical embodiments, the device allows for controlled, site-specific elution of an antimicrobial agent, such as Tobramycin, including defined elution over a period of time, such as 48 or 72 hours. The device allows for gas permeation spacing, i.e., air, under any temporary occlusive dressing, i.e., gauze, placed over the device and wounds. The beads and suture components of the device are easily and completely removable as an integrated unit prior to any surgical wound revision. Preferably, this polyamide suture material is substantially silicone free in order to provide improved bond formation between the beads and the suture material. The bead substrate and suture material are coated with a base coating containing Tobramycin and polyvinylpyrrolidone].

[0010] Based on these prior art documents and preliminary clinical observations, the inventors believe that Tobramycin eye ointment is highly effective in the treatment of chronic skin ulcers, often infected with Pseudomonas aeruginosa.

[0011] Experimental treatments have been performed using 0.3% Tobramycin but it cannot be excluded that an ointment with a lower presence of Tobramycin may be effective for the intended purpose.

[0012] The ointment used is Tobral ointment, containing 0.3% Tobramycin, that is manufactured by S.A. ALCON Couvreur N.V., 2870 Puurs (Belgium) and by ALCON CUSI S.A. C / Camil Fabra, 58, 08320 El Masnou, Barcelona (Spain).Summary of the invention

[0013] The purpose of the present invention is to provide a siliconized gauze soaked in a Tobramycin ointment containing Tobramycin in a percentage of 0,3% or less.

[0014] More specifically, the purpose of the invention is to provide a dressing device for treating chronic ulcerative lesions that can be supplied in pharmacies as a ready-to-use product for the home treatment of chronic ulcerative lesions.

[0015] The invention provides a device for dressing chronic ulcerative lesions, comprising:

[0016] - a gauze impregnated with an ointment,

[0017] - a support film provided with a perimeter edge, free from the gauze,

[0018] - a covering film, and

[0019] - a bag container, provided with sealing flaps,

[0020] the ointment with which the gauze is impregnated being a Tobramycin ointment.

[0021] Advantageously, the perimeter edge of the support film serves to keep the support film together with the covering film when the gauze impregnated with ointment is sandwiched inside the bag container, in which the gauze is packaged.

[0022] In use, after the gauze, impregnated with ointment, is removed from the bag container, the covering film is detached from the support film which is applied together with the gauze to the affected part of the patient.Brief description of the drawings

[0023] Further features and advantages of the invention will be more clearly apparent from the following description of a dressing device, illustrated by way of an indicative and non-limiting example in the attached drawing in which:Fig.l

[0024] [Fig.l] is an exploded perspective view of the component parts of the dressing device.Description of the embodiments

[0025] With reference to the figure, the device for dressing chronic ulcerative lesions according to the present invention comprises:

[0026] - a gauze 1 impregnated with an ointment,

[0027] - a support film 2, provided with a perimeter edge 20,

[0028] - a covering film 3, and

[0029] - a bag container 4, provided with sealing flaps 40..

[0030] The gauze is non-adherent, for example siliconized like Adaptic® or similar greasy gauze with a size of 7.6 x 7.6 cm or paraffinized like Cutiderm Sterile Paraffin Gauze Dressing with a size of 10 x 10 cm. However, gauzes with different dimensions can be chosen to adapt to the part of the patient on which they are intended.

[0031] According to the present invention, the ointment, with which the gauze 1 is impregnated, is a 0.3% Tobramycin ointment. The dose of Tobramycin ointment could be 500 mg or 1000 mg. Consequently, the doses for the same Adaptic® gauze or similar greasy gauze mentioned above are 8.6 mg / cm2and 17.3 mg / cm2.

[0032] Generic Tobramycin ointment is available on the market, manufactured by S.A.ALCON Couvreur N.V., 2870 Puurs (Belgium), and by ALCON CUSI S.A. C / Camil Fabra, 58, 08320 El Masnou, Barcelona (Spain).

[0033] The gauze 1 is sandwiched between a support film 2 and a cover film 3. The support film 2 and the cover film 3 have substantially the same shape and surface, possibly thecover film 3 could be slightly more extended to facilitate detachment from the support film 2.

[0034] The support film 2 has a perimeter edge 20, free from the gauze 1. The perimeter edge 20 serves to keep the support film 2 joined to the cover film 3 when the gauze 1, impregnated with the ointment, is inside the bag container 4. The bag container 4, of sterile material, has a sealing edge 40 that is torn when the sandwich of gauze 1 impregnated with ointment between the support film 2 and the cover film 3 is removed. Both films could be of sterile polyurethane. The cover film 3 is detached from the support film 2 to allow the application of the ointment-impregnated gauze 1 to the part to be treated, to which the support film 2 adheres with its peripheral edge 20.

[0035] It should be evident that only the ointment-impregnated gauze 1 is positioned over the skin with the ulcerative lesion, while the peripheral edge 20 of the support film 2 adheres by contact to the surrounding healthy skin of the patient.

[0036] Then, the support film, which supports the ointment-impregnated gauze, is applied to the affected part of the patient, causing the peripheral edge of the support film to adhere by contact to the healthy skin of the patient, adjacent to the chronic ulcerative lesion.

[0037] In this way, a caregiver does not come into contact with the ointment-impregnated gauze at the time of its application. Furthermore, the dressing does not require additional dressings.

[0038] The way of use of the dressing device according to the present invention is the following: to maintain the dressing, with replacement every 24 hours for at least 7 days; after each removal of the dressing, to wash the ulcerative lesion with physiological solution and antiseptic solution, for example Prontosan®.

[0039] It is understood that the present invention makes dressing more comfortable and easier, allowing it to be done in complete safety even in a home environment.

Claims

Claims

1. 1. A dressing device for treating chronic ulcerative lesions, characterized by comprising:- a gauze (1) impregnated with an ointment,- a support film (2), equipped with a perimeter edge (20) free from the gauze (1),- a covering film (3), and- a bag container (4), equipped with sealing flaps (40), the ointment with which the gauze (1) is impregnated being a Tobramycin ointment.

2. 2. The device according to claim 1, wherein Tobramycin is contained in the ointment in a percentage of 0.3%.

3. 3. The device according to claim 2, wherein a dose of 0,3%Tobramycin ointment on the gauze (1) is comprised between 8.6 mg / cm2e 17.3 mg / cm2.

4. 4. The device according to claim 1, wherein Tobramycin is contained in the ointment in a percentage less than 0.3%.

5. 5. The device according to claim 1, wherein the gauze (1) is a siliconized gauze

6. 6. The device according to claim 1, wherein the gauze (1) is a paraffinized gauze.

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