Multifunctional-reinforced dressing

Abstract

This invention relates to a surgical or medical dressing which comprises a supporting and reinforcing layer of elastomeric material (as polyethylene homopolymer) embedded in the composition of honey/additives, to supplement the mechanical strength, which would be fabricated as a single integral piece, intended to provide multi-functional properties in the wound environment, particularly for promote or expedite the regeneration or repair deep tissue injuries or chronic wounds such as ulcers.

Several additional characteristics of this new dressing provide an advantage to any wound care product developed from it. First, the biomaterial retains many biological properties of its major constituents (honey/additives). Second, the application of this safety dressing is greatly simplified particularly for pediatric burn Care.

Claims

1. A multifunctional -reinforced dressing suitable for promote or expedite the regeneration or repair of skin tissues COMPRISING: a reinforcing layer of flexible, inert, and removable reticulated elastomeric material (as polyethylene homopolymer), connected entirely to the honey/additives composition, essential to achieve the desired mechanical and physical properties for its intended function.

2. The multifunctional -reinforced dressing according to claim 1, wherein the honey/additives composition COMPRISING highly purified substances, which include in every single dressing the products and following amounts: Honey bees: 30.66 g, aqueous extract seed from Trigonella foenum-graecum 7.34 g, Policresulen 120,478 mg and gelling agent Agar-Agar 0.522 g.

3. The multifunctional-reinforced dressing according to claim 2, COMPRISING a reinforcing layer of flexible, inert, and removable reticulated elastomeric material (as polyethylene homopolymer) embedded in the honey/additives composition during gel formation, exerting a change in the appearance and physical characteristics of the dressing.

4. A method for use in Human & Veterinary Medicine, to promote or expedite the regeneration or repair of the deficient stromal connective tissue, as well as stimulating re-epithelialization, in a variety of injuries or disorders involving the skin tissues, due to trauma, diseases, or surgery, said method consist of contacting said site with the multifunctionalreinforced dressing of claims 1 to 3.

5. The process for the preparation of the multifunctional -reinforced dressing according to claim 1, COMPRISING carrying out the following steps in the order given: A. add fenugreek extract (1 liter), purified honey bee 4,231 kg and Agar-Agar 72,000 g. B. Heating for 1 hour 30 minutes (until boiling of the mixture) and mixing at 10 minute intervals. C. remove from heat and add 40 ml. of policresuleno (C23H24012S3 (2-hydroxy-3,5- bis[(4-hydroxy-2-methyl-5-sulfophenyl) methyl]-4-methylbenzenesulfonic Acid) D. Strain the solution through fine mesh to avoid lumps E. cool and keep it at 45 C. F. fill in individual trays a weight of 38.8 grams of the solution. G. embedded in the tray the reinforcing layer of reticulated elastomeric material. H. permit the solution/reinforcement layer to dry for 12 hours at room temperature. I. placed and closed in appropriate packaging the final product for sterilization. J. End product sterilization by ethylene oxide or plasma sterilization, or with -radiation, using a standard dose of radiation (e.g., 2.5-3.5 MRad).

Description

DETAILED DESCRIPTION

[0077] In the discussions herein, several terms are used. To provide a clear and consistent understanding of the specification and claims, the following definitions are provided.

[0078] Acutesharp, severe, having rapid onset, severe symptoms and a short course, not chronic.

[0079] AngiogenesisThis occurs during the proliferative phase of healing when new blood vessels infiltrate the wound and endothelial budding forms capillaries.

[0080] Adhering dressingthe quality of clinging or being closely attached

[0081] Antimicrobial agentpreventing the development or pathogenic action of microbes, helps decrease an infection and allows healing of a wound

[0082] Bacterialunicellular microorganisms, lacking chlorophyll, many kinds of bacteria, creating an infection

[0083] Chroniclong, drawn out, applied to a disease that is not acute.

[0084] Chronic woundcovered with necrotic (dead) material and surrounded by cellulites, also is described as an infected wound.

[0085] Debridementthe process of removing dead/unhealthy and/or contaminated tissues, foreign bodies, and other debris on the wound, using mechanical, enzymatic or sharp techniques.

[0086] DressingAny of various materials utilized for covering and protecting a wound.

[0087] Epidermisthe outer layer of skin.

[0088] EpithelializationThe process of the formation of new epithelial tissue -the upper layer of the skin.

[0089] Eschara slough, especially one following a cauterization or burnany agent used to destroy dead tissue and to cause sloughing which produces an eschar (a blackened area) in the treatment of skin disease.

[0090] ExcisionIs a surgical procedure requiring incision through the deep dermis (including subcutaneous and deeper tissues) of open wounds, burn eschar, or burn scars.

[0091] Exudatesthe material that often forms over an open wound. It consists of proteinaceous material from the wound itself.

[0092] Granulation tissueNewly formed vascular tissue (fragile capillaries) normally produced in the healing of wounds of soft tissue and ultimately forming the scar; it consists of small, translucent, pink to red, nodular masses of granulations that fill in an open wound bed during the proliferative phase of healing.

[0093] InfectionThe host response to bacterial, viral or similar invasion.

[0094] InflammationA non-specific host response to invasion of foreign material.

[0095] Lesionany visible, local abnormality of the tissues of the body, as a wound, sore, rash, or a boil.

[0096] Necrosislocalized tissue death that occurs in groups of cells in response to disease or injury.

[0097] Purulentproducing or containing pus.

[0098] SterilizationA process that kills and/or removes all classes of microorganisms and spores.

[0099] StromaThe supportive framework of an organ usually composed of connective tissue.

[0100] Superficialconfined to the surface.

[0101] Tissue regenerationHealing in which lost tissue is replaced by proliferation of cells which reconstruct the normal architecture.

[0102] Tissue repairHealing in which lost tissue is replaced by a fibrous scar, which is produced from granulation tissue.

[0103] Treatment or treatingrefers to any means of control of a condition or disorder, including prevention or prophylaxis, cure and relief, or relief of development of the condition or disorder.

[0104] Ulcera circumscribed, craterlike lesion of the skin or mucous membrane resulting from necrosis that accompanies some inflammatory, infectious, or malignant processes.

[0105] Wound dressingis a material applied to a wound or a diseased part of the body, with or without medication, to protect and assist healing.

[0106] From a wound care perspective, the growing prevalence and incidence of non-healing acute and chronic wounds is a concern, and numerous resources are available to clinicians across practice settings in wound-burn care, with limited success.

[0107] Accordingly, it is a general object of this invention to provide medical surgical dressing and methods of use and manufacture, which overcome the disadvantages of the prior art, and which fulfill the need set forth above.

[0108] In a first embodiment, the use of appropriate wound care interventions, can substantially improve clinical outcomes and reduce unnecessary morbidity and mortality.

[0109] In a specific embodiment, the new technology refers to further improvements in patient care and better procedures involved in wound dressings and surgical wound care.

[0110] In a second embodiment, the present disclosure, is directed to a new multi-functional composition of honey/additives, with an internal reinforcing material to supplement the mechanical strength, and for promote or expedite the regeneration or repair of skin tissues.

[0111] In another embodiment, there is provided a method of manufacturing a dressing, said method including the steps of: a) preparing a composition including honey/additives in a preferred form; and b) combining said honey composition with a preferred elastomeric material, before gelling of the composition has initiated.

[0112] The novel features which are believed to be specific to the invention, will be better understood from the following description of preferred embodiments.

[0113] In a specific embodiment, the present disclosure is directed to a new and effective method for promote or expedite the regeneration or repair of skin tissues, with a biocompatible medical-surgical reinforced dressing, which comprises a supporting and reinforcing layer of reticulated elastomeric material (as polyethylene polymer), embedded and connected entirely in the honey/additives composition.

[0114] The invention relates, in another embodiment, for the human or veterinary use of novel multifunctional reinforced dressing, to promote or expedite the regeneration or repair of skin tissues, in a variety of injuries or disorders, due to trauma, disease, or surgery.

[0115] In the broadest aspect of this embodiment of the invention, the dressing includes a natural honey/additives composition and synthetic polymer of reticulated elastomeric material (as polyethylene polymer), which provides support to the dressing structure.

[0116] In a specific embodiment of the invention, the honey/additives composition is reinforced with a biocompatible synthetic polymer.

[0117] Continuing the embodiment, the reinforcing dressing preferably comprises a scrim made of reticulated elastomeric material, that has already been proven to be nontoxic and biologically compatible, and polyethylene homopolymer admirably fits this requirement.

[0118] In further embodiments of the invention, the inclusion of the reticulated elastomeric material (as polyethylene polymer) in the honey/additives composition, enhance the strength of the product, and thus, provide more security against disintegration of the composition, under normal handling conditions.

[0119] Continuing the embodiment, the reinforcing material is preferably in the form of a net, which correspond substantially in shape and dimensions, to those of the dressing to be coextensive therewith.

[0120] In this embodiment, the reinforcing material is perforated, to allow bond physically two or more dressings, through the perforations, to the desired shape for its desired uses.

[0121] Continuing the embodiment, the incorporation of the elastomeric reinforcing material increases the overall strength of the dressing, together with their conformability, and allows to be molded to fit the surface to be covered.

[0122] In another aspect of the invention, the supporting and reinforcing layer of elastomeric material provides structural integrity to provides a desirable combination of tensile strength and conformability, which facilitates the application or removal, or the repositioning of the dressing to the patient's skin.

[0123] In another embodiment, the malleability of the dressing improves optimum contact with an irregularly shaped surface of a wound bed, to effect preferred healing.

[0124] In various embodiments, the reinforcement elastomeric material provides strength sufficient to permit the user to place and manipulate the dressing onto tissue of a patient, in contemplated applications.

[0125] In another embodiment, the dressing of the present disclosure can be used to promote or expedite the regeneration or repair of skin tissues in any subject which require the use, including but not limited to humans, primates, and domestic, farm, pet, or sports animals, such as dogs, horses, cats, sheep, pigs, cattle, rats, mice, and the like.

[0126] In another embodiment the present invention provides a wound dressing which offers significant advantages in controlling the environment of the wound surface and which may remain on the surface of the skin over an extended period, until the wound is healed, to the extent that it no longer requires a surgical dressing.

[0127] In another embodiment, a further object of this invention is to provide medical dressing which are easy to use, can be readily manufactured, are low in cost, and effective therapeutically for the acceleration of tissue repair.

[0128] Continuing the embodiment, the dressing properties allow the use in the medical field as skin protectants, as a general cover for injured or burned skin, as a wound cavity filler, or for exudative, necrotic, dehiscing, and other types of wounds.

[0129] In another aspect of the invention, the dressings that may be used to the care of chronic wounds, including non-infected as well as infected wounds, and skin ulcers.

[0130] Continuing the embodiment, there is provided a dressing to speed up the healing process, with antimicrobial, anti-inflammatory, and debriding properties.

[0131] In certain embodiments, various actives/agents are included to address concerns, that extend beyond the ability of the performance of the honey. These include gelling agents, plant extracts and compounds from the group of phenol and acetic acid.

[0132] In a specific embodiment, in the multifunctional reinforced dressing for purposes of the pH reduction and bacterial control, are incorporated three products: raw honey, methyl-Phenol [Policresulen (Condensation product of metacresolsulfonic acid & methanal)], and acetic acid.

[0133] Continuing the embodiment, the dressing can be administered by any suitable technique, by removing loose epithelium and necrotic skin tissues at the wound site.

[0134] In another embodiment, is provide wound dressings which are easy to apply in very few steps, to fit the shape of the complex curves of a body, and for application to a plurality of wound types.

[0135] In various embodiments, the dressing can be maintained in its position on the skin over extended periods of time, which reduces the frequency of dressing changes, and leads to reduced pain, added comfort and mobility to injured children.

[0136] In another aspect of the invention, the extended permanence of the dressing over the damaged tissue surface, minimizes disturbances of the wound healing processes, which produces a striking improvement in the recovery of the tissue.

[0137] In another embodiment, is attained a reinforced dressing which is capable of being easily handled by a surgeon without the undesirable flaccidity in the prior art composition, leading to ease of application and more rapid fixation,

[0138] In one embodiment, the tissue it is cut of a size and shape that is desired for the applicable surgical procedure in which will be used, and if preferred, by interlacing one or more connected dressings by suturing, to cover greater extent of the wounds.

[0139] While the compositions and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the methods and it will be understood that various omissions, substitutions and changes in the form and details may be possible, without departing from the spirit of the present disclosure.

[0140] The following examples are included to demonstrate preferred embodiments of the disclosure. It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventor to function well in the practice of the invention, and thus can be considered to constitute preferred modes for its practice.

EXAMPLE #1

[0141] In order that this aspect of the present invention is novel and inventive over the disclosure of WO 2014041440 A1, publication date Mar. 20, 2014, for the purpose of any jurisdictions in which that application constitutes prior art against the present application, in the said aspect of the present invention, the process of preparation corresponds entirely to the first three steps of preparation of such invention and may be provided in the same way and with the same embodiments, examples and preferences.

[0142] In this process, it has added the following variation in the method of manufacturing the dressing: preparing a composition including honey/additives in a preferred form, according to the first three process of preparation; and in a fourth process: combining said honey composition with a preferred elastomeric material, before gelling of the composition has initiated.

[0143] 16

[0144] In this sense the way of preparing the dressing has the following sequences:

[0145] The method of manufacturing the dressing, comprising the steps:

[0146] A. add fenugreek extract (1 liter), purified honey bee 4,231 kg and Agar-Agar 72,000 g.

[0147] B. Heating for 1 hour 30 minutes (until boiling of the mixture) and mixing at 10 minutes intervals.

[0148] C. remove from heat and add 40 ml. of policresuleno (C23H24012S3 (2-hydroxy-3,5-bis[(4 hydroxy-2-methyl-5-sulfophenyl) methyl]-4-methylbenzenesulfonic Acid)

[0149] D. Strain the solution through fine mesh to avoid lumps

[0150] E. cool and keep it at 450 C

[0151] F. fill in individual trays a weight of 38.8 grams of the solution.

[0152] G. embedded in the tray the reinforcing layer of reticulated elastomeric material.

[0153] H. permit the solution/reinforcement layer to dry for 12 hours at room temperature.

[0154] I. placed and closed in appropriate packaging the final product for sterilization.

[0155] J. Product sterilization by ethylene oxide or plasma sterilization, or with -radiation, using a standard dose of radiation (e.g., 2.5-3.5 MRad).

[0156] Naturally, the above-mentioned steps of manufacturing devices of the present invention may further include additional steps, such as for quality control purposes. These additional steps may include visual or other types of inspections during or between the various steps, as well as final product inspection including chemical and/or physical testing and characterization steps, as well another quality control testing.

EXAMPLE #2

Methods of Use

[0157] The multifunctional reinforced dressing described herein may be used in both the human and veterinary fields, for temporary coverage of superficial and deep second-degree burn (partial thickness burn) and for autolytic debridement and stimulated angiogenesis in full thickness wounds, including necrotic or sloughy wounds, pressure ulcers, leg ulcers, surgical wounds, trauma wounds (abrasions, lacerations, erosions), donor sites and malodorous wounds.

[0158] Target patient group(s): patients with critically colonized wounds, patients with clinically infected wounds that are being treated with oral or intramuscular-intravenous antibiotic therapy.

Placement Procedure for Temporary Covering:

[0159] Prepare wounds very meticulous, to guarantee lesion is entirely excised or surgically debrided, to ensure the wound bed and edges contain viable structures, free of debris and necrotic tissue.

[0160] With normal saline solution gently irrigated the injury.

[0161] Debride blister and loose skin. Cleanse with warmed normal saline.

[0162] Avoid broad area of capillary bleeding, which can lead to devitalized tissue.

[0163] Prepare/open dressing items on table. Open the outer pocket used gloved hands.

[0164] The wound dressing of the present disclosure includes a second dressing with the same material of the reinforcement structure inside the film to enhance the effect of a wound therapy treatment.

[0165] Place the product and polyethylene mesh in a sterile field.

[0166] Translated onto the wound bed and gently remove the dressing with gloved hands. Cut to size with clean or sterile scissors and apply.

[0167] The Dressing can overlap healthy tissue by 1 to 2 mm. If the wound is larger than a single dressing, then multiple dressings may be used, and if preferred, by interlacing one or more connected dressings by suturing, to cover greater extent of the wounds.

[0168] To ensure close contact, make sure careful distribution, with no wrinkles or bubbles.

[0169] Preparing Bowl with sterile saline solution and immersing the polyethylene mesh (second dressing) for 15 seconds.

[0170] The secondary dressing is applied over the primary dressing and bandaged with elastic tubular dressing (third dressing) to preserve adherence and permit easy inspections.

[0171] Dressings Fixation and compression are of significant importance to ensure the dressing adheres to the wound without shear.

[0172] Secondary dressing also stabilizes the dressing to prevent dislodgment.

[0173] In the Day, exposed the injury site to light (goose lamp 60 Watts) five minutes every two hours, for membrane desiccation for 48 hours.

[0174] Reassess wounds after 24-48 hours and see the wound. Not touch the dressing until is advantageous to remove (seven or more-day post implant).

[0175] On inspection, at 48-72 hours, the dressing changes the yellow color to a brown aspect, similar to crust.

[0176] Opaque and dry appearance indicates burn wound has re-epithelialized.

[0177] Careful inspection of the wound site and the clinical monitoring of patients' conditions allow the clinician to prolong the interval between dressing changes. It is the authors' opinion that, at most, one week of continuous without a dressing change is acceptable if no infectious signs develop.

[0178] At seven or more days the dressing may gradually peel and may be removed with gently irrigation with saline solution or by shower. They ensured pain-free removal after complete healing of the wound. Do not forcibly remove sections of the dressing that have adhere to the wound. Later, with new irrigation, they remove completely.

[0179] In some cases, it may be possible to separate the mesh and substrate by carefully pulling them apart. However, to avoid the possibility of tearing the dressing it is preferred that separation be facilitated by the use of saline solution.

[0180] Dressings to protect the practical active dressing as follows:

[0181] High-quality white polyethylene net and a Tubular Elastic Bandage applied over polyethylene layer, to protect the site and to reduce the potential of shearing and graft dislodgement.

[0182] Both can be left in place for extended periods without detrimental effects to the underlying wound. In this sense, preparing Bowl with sterile saline solution and immersing the polyethylene mesh (second dressing) for 10 seconds.

[0183] Next the wound bed is overlaid with this material in direct contact with wound surface and then bandaged with elastic tubular dressing (third dressing) to preserve adherence and permit easy inspections.

[0184] Take care in the selection of the appropriate stretch of the tubular dressing in arterial leg ulceration because they impaired circulation in this kind of patients.

[0185] Active movement are encouraged to maintain the range of motion and to reduce the amount of edema.

[0186] The use of a wound dressing in this manner has been found to promote healing by reducing the probability of infection, stimulating the deposition of granulation tissue and other beneficial processes.

[0187] Complications: The following complications are possible with the use of any wound dressings. If any of the conditions occur, the dressing should be removed: infection, inflammation, allergic reaction, excessive redness, pain or swelling. Complications that the surgeon may encounter further than infection include seroma and/or hematoma formation, and graft contracture. Although wound infection is rare, when this is suspected, appropriate bacterial identification is obligatory and according to the cultivated microorganism's antibiotics should be prescribed.

EXAMPLE #3

Comparative Clinical Study to Assess the Efficacy and Safety of New Multifunctional Dressing

INTRODUCTION:

[0188] The therapeutic approach and intervention in the formation of granulation tissue in difficult to healing ulcers, suppose provide safe and quality care to people affected by these conditions.

[0189] This implies the need to investigate what may be the most effective possible protocols to guide and direct the actions of care for such chronic and complex lesions, to improve the quality of life of patients and incorporate in the country advanced and effective technology with the latest scientific knowledge and solution at a low cost.

[0190] OBJECTIVE: To compare the clinical results of treatment with traditional cures and advanced treatments with multifunctional dressing in hard-to-heal wound.

MATERIAL AND METHODS:

[0191] The development and evaluation of a randomized trial with two treatment groups for patients with difficult to cure ulcers, one to which with a multifunctional dressing with cures every 3 days and another with wet-to-dry with gauze dressings and saline changed daily.

[0192] The study population is composed 380 adults treated in the Outpatient Department of Surgery at Roosevelt Hospital in Guatemala City in the period from January to October of 2,014, with Protocols that had been reviewed and approved by ethics committee.

[0193] Patients must meet the eligibility criteria as: both sexes, over 18 years, presence of ulceration in the lower limbs with a maximum diameter of 150 cm.sup.2 and equal to or greater than 90 days of evolution.

[0194] We included eligible subjects, according to the criteria of inclusion and exclusion, with individual clarification to the patient and family about the goals and methods of the study and was provided informed consent form, which included reading, understanding and signature for inclusion in the investigation.

[0195] Treatments were performed with the multifunctional dressing in pairs new cases and in wet to dry no pairs cases, with Primary outcomes in relation to the formation of granulation tissue and/or epithelial tissue in the wound bed, with collection data measurement in 4 times (at baseline, four, eight and twelve weeks).

[0196] For the assessment of characteristics at baseline and evolution of treatment of injuries, a modified and reduced table the report of Houghton et al,.sup.1 which included visual evaluation and measurement of five components was developed: size, type and amount of necrotic tissue, type and amount of granulation tissue.

[0197] A number from 0 to 4 was assigned to each of them, then count the five components to get the total score of the wound, with the possible total scores range from 0 to 24, with zero representing a completely healed ulcer.

[0198] Reliability, and sensitivity was determined by the indicated visual assessments and ruler measurements (maximum and maximum width of the wound length), by a single evaluator during the study period.

[0199] For the safety, were included assessment of symptoms reported by patients and clinical signs observed by the physician.

RESULTS:

[0200] 380 patients were included in the evaluation (190 in each group studied), of which 61% were female and 39% male.

[0201] Of this number only 153 patients completed the study (81%) of the multifunctional dressing group and 98 cases (52%) of the Wet-to-dry and gauze dressings with a pronounced treatment discontinuation in the first four weeks in both groups.

[0202] The greatest treatment discontinuation was particularly due to lack of patient compliance to healing, which was most evident in the treatment group Wet-to-dry and gauze dressings.

[0203] On average 3 weekly cures for the multifunctional dressing and 10 weekly cures for the Wet-todry and gauze dressings were performed.

[0204] It was determined that in 203 patients with ulcerations were diabetic patients (54%), and ulcerations due to burns, soft tissue infections in 96 cases (25%), occupying venous insufficiency third place with 54 patients (14%) and arterial disease with 27 cases (7%).

[0205] The lesions were present in the foot in 53% of cases, in the leg in 23% of them, in the sacral region in 16% of them, and trochanteric region at 8%.

[0206] Regarding the time evolution of lesions in 52% of cases ulceration was present between three to six months and the remaining 48% of cases over six months.

[0207] At the first evaluation at four weeks, it was shown that the ulcerations that were treated with the multifunctional dressing had progressed adequately to healing with intact skin or in close proximity to, in 37% of cases compared with 11% the wet dry cures.

[0208] When making the second assessment at eight weeks, it was shown that the ulcerations that were treated with the multifunctional dressing had progressed to healing with intact or near, in 50% of cases, in contrast to the progress of 20% the wet dry cures.

[0209] When performing the third evaluation at twelve weeks (end), it was shown that the ulcerations that were treated with the multifunctional dressing had progressed to healing with intact skin or in close proximity to, at 64%% of cases, in contrast to the progress of 25% of the wet dry cures.

CONCLUSIONS

[0210] The results of a study showed that the multifunctional dressing leads to improved and accelerated tissue repair-regeneration in chronic ulcers from healing compared to healing method from the Wet-to-dry and gauze dressings.