Multifunctional high-efficiency anti-adhesion and easy-to-change wound dressing and preparation method thereof

Abstract

The application provides a multi-purpose high-efficiency anti-sticking and easy-to-change wound dressing and a preparation method thereof. The wound dressing comprises a non-woven fabric layer, an effective component layer, a netting layer and a plastic film layer. The effective component layer is prepared from the following substances: calcium sulfate, a zinc compound, iron oxide, vegetable oil, beeswax and vaseline. The wound dressing can dissolve and remove eschar and necrotic tissue, and is used for deep burn and scald without cutting eschar and skin grafting. The wound dressing can adjust the pH value of a wound to neutral, release analgesic and antibacterial functions, activate the residual dermal papilla appendages under the eschar, regenerate the deep wound in situ, and realize skin healing without or with few scars and without sticking to the wound. The wound dressing is easy to peel and change, is suitable for all types of skin wounds and ulcers in early, middle and late stages, has significant effects, has no skin irritation and no sensitization, and is high in efficiency and safety.

Description

Technical Field

[0001] This invention belongs to the field of dressing technology, and relates to wound dressings, and more particularly to a multifunctional, highly efficient, non-adhesive, and easily replaceable wound dressing and its preparation method. Background Technology

[0002] Various skin injuries (thermal injuries, mechanical injuries), bacterial infections (furuncles, carbuncles, abscesses), and vascular skin diseases (varicose veins in the lower extremities, gangrene due to arteriosclerosis obliterans, vasculitis, diabetic foot, etc.) can damage and ulcerate the skin, even leading to refractory chronic ulcers. In addition to internal medicine treatment, the protection and external application of medication directly to the wound to promote healing and repair are essential, and often the primary, treatment methods for such skin injuries and ulcers. Throughout history, medical professionals have developed a wide variety of topical medications and materials for wound care. These include ointments, powders, and oils containing various traditional Chinese medicine ingredients. There are also topical wound dressings made from materials such as petrolatum, nano-silver, chitosan, alginate, hydrocolloids, hydrophilic cellulose, and polyurethane foam.

[0003] The aforementioned topical preparations and dressings vary in their permeability, moisturizing properties, heat retention, absorbency, anti-inflammatory effects, comfort, and versatility, each possessing its own advantages and disadvantages. These differences manifest in various aspects, including wound isolation and protection, heat retention, moisture retention, absorption of exudate, separation and adsorption of foreign matter adhering to the wound surface, dissolution and removal of eschar and necrotic tissue, analgesia, anti-inflammation, promotion of granulation tissue and epithelial regeneration, and ease of removal and replacement, as well as user-friendliness. To date, no topical drug preparation or dressing device possesses the vast majority of advantages while having very few disadvantages has been developed.

[0004] The open wound therapy, which involves applying various ointments, creams, medicated oils, or liquids, lacks the function of isolating and protecting the wound because it does not cover the wound with dressings. It lacks effective shielding, moisturizing, warming, and absorption properties for the wound, failing to create a buffer environment conducive to repair in skin injuries or ulcers.

[0005] Changes in external air pressure, temperature, and humidity, along with wound exudate, dirt adhesion, and invasion by insects and dust particles, can all increase wound pain, tissue necrosis, and secondary bacterial infections. As for medical wound dressings made from various fiber materials and excipients, used to cover and bandage skin wounds or ulcers, while they provide a barrier, they all share some common drawbacks due to differences in the types of fiber materials and excipients used, aside from variations in heat retention, moisture retention, and breathability.

[0006] Firstly, the pH value of various medical dressings is either too low or too high, which can irritate the wound and cause pain. Furthermore, there is a lack of products that can bidirectionally adjust the pH value of the wound to neutral.

[0007] Secondly, the moisturizing time is too short, which prevents the wound from remaining moist for an extended period to facilitate wound repair.

[0008] Third, it does not have the function of dissolving, separating, or removing necrotic tissues such as eschar and necrotic tissue from damaged wounds.

[0009] Fourth, all kinds of medical dressings tend to dry out after use and adhere to the wound. They are not easy to separate and remove when changing the dressing, and removing them will cause severe pain.

[0010] Fifth, some medical dressings containing ointments, such as "Mebo Ulcer Dressing," while having better moisturizing properties than other medical dressings made of materials like nano-silver, methyl polysaccharide, alginate, and hydrocolloids, are still oil-wax products. This results in a low oil retention capacity when soaked into the dressing, a short oil-retention period on the wound, and the dressing tends to stick to the wound tissue during replacement, making it difficult to remove. Furthermore, it tends to stick to the packaging bag during packaging, making it difficult to separate and use, thus inconvenient for both packaging and use.

[0011] Modern burn medicine and its clinical treatment techniques all require escharotomy and autologous skin grafting for deep second- and third-degree burns. Currently, there are no external medications, dressings, or other external treatment methods that can spontaneously dissolve and remove the eschar while simultaneously preserving and activating the remaining dermal tissue beneath, promoting its regeneration. This would allow patients with deep burns to avoid the pain of escharotomy and skin grafting, and prevent scarring at both the graft and donor sites.

[0012] Skin ulcers are a common and frequently occurring disease in clinical medicine, generally classified into two types. First, exogenous skin ulcers, which are ulcers formed by damage to skin tissue caused by external factors, such as burns, frostbite, cuts, contusions, and abrasions. Second, endogenous skin ulcers, which are degenerative ulcers caused by damage to the skin due to internal diseases, such as suppurative boils and abscesses, herpes tuberculosis, diabetic foot, varicose veins of the lower leg, gangrene of the foot due to arteriosclerosis obliterans, thromboangiitis obliterans foot ulcers, and necrotic skin ulcers caused by cancer. Although there are many types of skin ulcers and they vary greatly, they all share a common characteristic: the integrity of the skin surface, and even the subcutaneous tissue and muscle layer, is disrupted, resulting in varying degrees of morphological changes such as exudation, bleeding, purulent discharge, degeneration, ulceration, and necrosis. Doctors must treat skin ulcers not only internally but also externally. This requires both systemic medication (such as oral medication and injections) tailored to the specific condition to improve overall bodily functions and promote the healing of damaged skin ulcers, and localized medication for ulcers of varying sizes and depths, allowing the medication to directly target the affected area and accelerate healing. This places higher demands on the attending physician, requiring expertise in both internal and external treatments, the ability to select or prepare the best topical medications, and the use of optimal techniques for local treatment. Summary of the Invention

[0013] To address the aforementioned problems, this invention provides a multi-functional, highly efficient, non-adhesive, and easily replaceable wound dressing and its preparation method. This wound dressing can dissolve eschar and necrotic tissue from the wound, eliminating the need for eschar removal and skin grafting in deep burns. It bidirectionally regulates the wound's pH to neutral, releases analgesic and antibacterial functions, activates residual dermal papillae under the eschar, promoting in-situ regeneration and skin healing in deep wounds with minimal or no scarring. It is non-adhesive to the wound surface, easy to remove and replace, and suitable for use in all stages of various skin traumas and ulcers (early, middle, and late stages). It has significant effects, is non-irritating and non-sensitizing to the skin, and is highly effective and safe.

[0014] To achieve the above objectives, the present invention adopts the following technical solution:

[0015] A multi-functional, high-efficiency, non-adhesive, and easily replaceable wound dressing, the wound dressing comprising a non-woven fabric layer, an active ingredient layer, a mesh layer, and a plastic film layer, wherein the active ingredient layer is made from the following substances: calcium sulfate, zinc compounds, iron oxide, vegetable oil, beeswax, and petrolatum.

[0016] The inventor is dedicated to developing a topical preparation that enables deep burns to be treated without eschar removal or skin grafting. This preparation dissolves eschar and necrotic tissue, bidirectionally regulates the wound's pH to neutral, releases analgesic and antibacterial properties, activates the growth of residual dermal papillae under the eschar, promotes the regeneration of deeply damaged tissue, and facilitates healing with minimal or no scarring. It does not stick to the wound during dressing changes, is easy to remove and change, and is suitable for use in all stages of various skin traumas and ulcers (early, middle, and late stages). It is highly effective, non-irritating, non-sensitizing, and a safe and highly effective topical treatment.

[0017] Following burns and trauma, the most correct and effective treatment for skin wounds, in order of frequency, is debridement, wound protection, anti-inflammation, analgesia, dissolution of eschar and necrotic tissue, promotion of granulation tissue and epithelial growth, until wound healing. In long-term clinical trials, the inventors observed that the application of topical wound care medications and materials creates a buffer environment on the skin wound. The moisturizing, warming, breathable, absorbent, and pH-regulating effects of this environment are crucial to the treatment efficacy and prognosis of burns and other skin injuries. An effective barrier can block the influence and damage to the wound from external airflow, dust, insects, and microorganisms. Appropriate temperature and humidity can relieve pain, improve blood circulation in the wound floor and surrounding tissues, increase wound secretions, remove wound debris, and dissolve and remove eschar and necrotic tissue. Appropriate breathability can regulate and maintain the temperature and humidity of the wound, while good absorbent properties can absorb and remove exudate, inflammatory secretions, dissolved debris, blister skin, eschar, and necrotic tissue, facilitating autolysis and debridement. In particular, the pH adjustment of the wound is crucial, especially with topical preparations or wound care materials. A wound pH less than 6 (acidic) promotes the growth of Staphylococcus aureus and Escherichia coli; a pH greater than 8 (alkaline) promotes the growth of Pseudomonas aeruginosa. Only when the pH is adjusted to 7-7.5 is the bacterial count minimized, infection mildest, and healing fastest.

[0018] After years of screening and repeated clinical trials, the applicant discovered that by mixing calcium sulfate powder with zinc oxide powder (including zinc carbonate and calamine) and adding vegetable oil and beeswax to form a semi-solid paste, which can be spread onto non-woven fabric, a thin, soft medical wound dressing can be made. This dressing is superior to other topical preparations and dressings in treating burns, mechanical injuries, and various chronic ulcers.

[0019] Through over thirty years of extensive clinical trials, it has been demonstrated that the technology can dissolve eschar and necrotic tissue from wounds, eliminating the need for eschar removal and skin grafting in deep burns. It also bidirectionally regulates the pH of the wound to neutral, releases analgesic and antibacterial functions, activates residual dermal papillae and appendages under the eschar, promotes in-situ regeneration and skin healing in deep wounds, and leaves little or no scarring. The dressing is easy to remove and change, suitable for use in all stages of various skin traumas and ulcers, with significant effects, no skin irritation or sensitization, and is highly effective and safe.

[0020] As a preferred embodiment of the present invention, the zinc compound is selected from one or more combinations of zinc oxide, calamine and zinc carbonate.

[0021] As a preferred embodiment of the present invention, the vegetable oil is selected from one or more combinations of camellia seed oil, peanut oil, flaxseed oil and rice bran oil.

[0022] As a preferred embodiment of the present invention, the active ingredient is prepared by mass fraction from the following substances: 10%-25% calcium sulfate, 10%-25% zinc compound, 0.1%-0.5% iron oxide, 20%-40% vegetable oil, 10%-20% beeswax, and the balance being petrolatum.

[0023] In this invention, the combination of calcium sulfate and zinc oxide powders with vegetable oil can be formulated into a low-oil, semi-solid paste. When this paste is pressed onto non-woven fabric to make a dressing, the vegetable oil, which has excellent wound-protecting properties, is not lost within the dressing, increasing oil retention and extending its duration. Simultaneously, due to the good dispersibility of zinc compounds, the paste can penetrate evenly into the fiber gaps of the non-woven fabric during processing and coating, making it less prone to falling off. Furthermore, the good moisturizing properties of calcium sulfate microparticles enhance the moisturizing effect of the prepared medical wound dressing and prolong its moisturizing effect. This results in the dressing not sticking to the wound during dressing changes, making it easy to remove and eliminating the drawbacks of other dressings that adhere to the wound, causing pain and difficulty in removal.

[0024] The zinc compound used is insoluble in water, and the calcium sulfate is only slightly soluble in water, so it is not absorbed by the damaged wound. The resulting medical dressing is non-toxic and harmless to the human body, ensuring the safety of the product.

[0025] The resulting medical dressing has a pH value of around 7.0. It is non-irritating to acute injuries such as burns and scalds, as well as chronic ulcers, providing excellent cushioning and wound protection. When applied to the wound, it can bidirectionally regulate the pH value of inflammatory wounds caused by burns and scalds to neutral, thus exerting antibacterial and anti-inflammatory effects. Clinical observation using pH test strips has verified that using this dressing can adjust wounds that are acidic or alkaline due to bacterial infection to neutral. Clinically, infected wounds with a low pH value are often caused by Staphylococcus aureus and Escherichia coli decomposing sugars and producing acid; infected wounds with a high pH value are often caused by Pseudomonas aeruginosa decomposing amino acids and producing ammonia. Only by adjusting the pH value of the wound to neutral can the bacterial content be minimized and the infection reduced.

[0026] The trace amounts of iron oxide particles used in this invention serve a color-adjusting function, enabling the product to closely resemble skin color and providing a good comforting effect to patients.

[0027] This invention also provides a method for preparing the above-mentioned multifunctional, high-efficiency, non-adhesive, and easily replaceable wound dressing, the method comprising the following steps:

[0028] 1) Heat the vegetable oil to a boil and keep it warm;

[0029] 2) Add calcium sulfate, zinc compound, iron oxide, beeswax and petrolatum to the vegetable oil in step 1), stir well, let stand, and let it cool and solidify into a light red paste.

[0030] 3) Apply the paste obtained in step 2) evenly and press it onto the non-woven fabric to obtain a light red dressing;

[0031] 4) Cover the paste-like dressing with mesh, place the plastic film layer on the back of the dressing, put it into a composite aluminum-plastic film packaging bag, and seal the packaging to obtain a multi-functional, high-efficiency, non-stick, and easily replaceable wound dressing.

[0032] In this invention, a composite aluminum-plastic film is used for bagging and sealing, which can withstand 60°C radiation, facilitating irradiation sterilization. Simultaneously, the excellent sealing properties of the composite aluminum-plastic film bagging prevent the evaporation and oxidation of oils in this invention, ensuring stable quality and a shelf life of over 2 years.

[0033] As a preferred embodiment of the present invention, in step 1), the heat preservation time is 30-60 minutes.

[0034] As a preferred embodiment of the present invention, in step 2), the thickness of the paste is 0.5-2 mm.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] 1) This invention uses calcium sulfate and zinc oxide, which are insoluble (or slightly) in water, both with a pH of 7.0, are neutral, are not absorbed by the wound, and are non-toxic, harmless, and non-irritating to human tissue, to form the framework of the ointment. These are blended with vegetable oil to form a semi-solid paste, which increases the oil content and improves the duration of oil retention and wound protection when applied as a dressing. Calcium sulfate also has moisturizing properties, extending the moisturizing effect of the product. Zinc oxide has good dispersibility, allowing the ointment to penetrate deeply into the gaps between the nonwoven fabric fibers, making it less likely to fall off. Zinc oxide also has antibacterial and astringent properties. Removing calcium sulfate results in poor moisturizing properties in the dressing, causing it to adhere to the wound and be difficult to remove. Removing zinc oxide results in poor penetration and adhesion of the ointment to the nonwoven fabric fibers, causing the ointment to easily clump and fall off. It also reduces the antibacterial and astringent effects.

[0037] 2) This invention uses plant oil as the base because of its moisturizing and protective properties, and it can also be combined with calcium sulfate and zinc oxide to form a paste. If the plant oil is removed, or other liquid bases are used instead, a good paste texture cannot be produced.

[0038] 3) This invention uses beeswax as a shaping stabilizer, which utilizes its heat-melting and condensing properties to allow the ointment to solidify at room temperature. When applied to the wound, it is softened by body heat to exert its effect. If beeswax is removed, the ointment will separate into oil and powder, making it difficult to solidify and shape.

[0039] 4) This invention uses petroleum jelly to soften the paste without causing oil separation or seepage, thus increasing its stabilizing effect. If petroleum jelly is omitted, the paste will become unstable due to increased oil content and softening, while reduced oil content will cause cracking and reduced efficacy.

[0040] 5) The use of iron oxide in this invention enables it to be adjusted to a near-skin tone; if iron oxide is removed, it becomes difficult to adjust the color.

[0041] 6) This invention uses two powders, calcium sulfate and zinc oxide, and forms a semi-solid paste by mixing the powders with vegetable oil. This is fundamentally different from the traditional Chinese medicine ointment made simply by melting beeswax and sesame oil. (See *Yizong Jinjian*, Volume 65, *Huanglian*) First, it uses powder as a framework, blended with vegetable oil to form a paste, with an oil content far lower than traditional "oil-wax ointments" like Coptis chinensis ointment. This paste, when spread on non-woven fabric to make a dressing, can embed itself in the fiber gaps without being lost. This increases the oil retention capacity of the dressing and prolongs the oil retention and moisturizing time, which is beneficial for wound healing and eschar dissolution. Second, because the powder in the paste contains a large number of gaps, it is conducive to wound ventilation and absorbs wound exudate, dirt, and dissolved eschar and necrotic tissue. Third, the resulting dressing has good moisturizing and heat preservation, breathability and absorption, pH adjustment, antibacterial and anti-inflammatory properties, and barrier function, creating an optimal ecological environment for burn wounds and reversing and reducing the severity of the injury. While dissolving eschar, it protects and activates the regeneration of the remaining dermis and granulation tissue under the eschar, forming skin islands that connect to form patches, promoting skin growth and healing.

[0042] 7) This invention is used for deep second- and third-degree burns. After applying the dressing to the wound and securing it with gauze or bandaging, it provides optimal moisture retention (moderate moisture, preventing the wound from drying out or becoming soaked), heat retention, permeability (moderate ventilation, allowing excess exudate to drain away, which is then absorbed and carried away by the gauze and bandage), absorbency (absorbing and removing soot, dirt, blister skin, and eschar), anti-inflammatory properties (bidirectionally regulating the pH of the wound to neutral to inhibit bacteria and infection, and reduce edema), and intelligence (automatically dividing the wound into zones according to lesion depth, locking and isolating these zones, and targeting specific areas for treatment. It also locks in areas with excessive eschar exudate. This method confines the drained exudate within the affected area, creating a favorable buffer environment for the skin wound. It softens, dissolves, and removes eschar from deep burns, thus eliminating the need for painful, costly procedures like escharotomy and skin grafting. The wound dressing of this invention allows for early, layer-by-layer eschar dissolution and removal, while simultaneously protecting and activating the growth of any remaining dermal papillae. Once the eschar has completely fallen off, the remaining dermal papillae have significantly increased in number, gradually growing into small skin islands, which then enlarge and connect to form normal epidermis. This enables the repair of small to medium-sized deep second- to third-degree burns without escharotomy, skin grafting, or (micro)scarring. Attached Figure Description

[0043] Figure 1 This is a photograph of the actual wound dressing of the present invention.

[0044] Figure 2 This is a comparison chart of the effects of use on patients in Example 4.

[0045] Figure 3This is a comparison chart of the effects of use on patients in Example 5.

[0046] Figure 4 This is a comparison chart of the effects of use on patients in Example 6.

[0047] Figure 5 This is a comparison chart of the effects of use on patients in Example 7.

[0048] Figure 6 This is a comparison chart of the effects of use on patients in Example 8.

[0049] Figure 7 This is a comparison chart of the effects of use on patients in Example 9.

[0050] Figure 8 This is a comparison chart of the effects of use on patients in Example 10.

[0051] Figure 9 This is a comparison chart of the effects of use on patients in Example 11.

[0052] Figure 10 This is a comparison chart of the effects of use on patients in Example 12. Detailed Implementation

[0053] To facilitate understanding of the technical means, inventive features, objectives, and effects of this invention, the invention is further described below with reference to specific embodiments. However, the following embodiments are merely preferred embodiments of this invention and not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments described herein without creative effort are all within the scope of protection of this invention. Unless otherwise specified, the experimental methods in the following embodiments are conventional methods, and the materials and reagents used in the following embodiments are commercially available unless otherwise specified.

[0054] See Figure 1 The present invention provides a multi-functional, high-efficiency, non-adhesive, and easily replaceable wound dressing. The wound dressing includes a non-woven fabric layer, an active ingredient layer, a mesh layer, and a plastic film layer. The active ingredient layer is made from the following substances: calcium sulfate, zinc compound, iron oxide, vegetable oil, beeswax, and petrolatum.

[0055] The wound dressing of the present invention has the following characteristics:

[0056] 1. pH value: 7-7.5.

[0057] 2. Moisturizing properties (moderate moisturizing, preventing the wound from drying out or becoming macerated).

[0058] 3. Thermal insulation (moderate insulation to prevent the wound from getting cold).

[0059] 4. Adsorption (absorbs and removes soot, dirt, grime, seepage, foam, and sludge from the surface).

[0060] 5. Anti-inflammatory properties (by bidirectionally regulating the pH of the wound to neutral, inhibiting bacteria and fighting infection, and reducing edema).

[0061] 6. Intelligent features (automatic zoning based on lesion depth, zone containment, and targeted treatment. It isolates and locks in areas with excessive eschar dissolution and exudation, confining the drained exudate within that area. If there is too much exudate, it will seep through the patch and be absorbed by the outer bandage and gauze. Remarkably, no matter how much exudate or solution there is, it is only contained within the corresponding area and will not flow to surrounding areas without exudate, areas with new skin growth, or uninjured normal skin areas).

[0062] 7. Versatility (applicable to all stages of burns, scalds, chemical burns, and electrical burns, from early to late). It features wound ecology medicine characteristics. It can create an optimal physiological environment for the damaged skin to buffer damage reduction, stop injury, recover, and regenerate. Its manifestations include: ① Early stage: reversing and reducing the severity of the injury, activating and reviving residual dermal appendages under the eschar; ② Mid-stage: autolytic debridement, eschar removal and swelling reduction, activation of residual dermal papillae and appendages; ③ Late stage: hyperplasia of skin islands, epidermal regeneration, scar removal and skin replacement, restoration of shape, and functional recovery.

[0063] The inventor is dedicated to developing a topical preparation that enables deep burns to be treated without eschar removal or skin grafting. This preparation dissolves eschar and necrotic tissue, bidirectionally regulates the wound's pH to neutral, releases analgesic and antibacterial properties, activates the growth of residual dermal papillae under the eschar, promotes the regeneration of deeply damaged tissue, and facilitates healing with minimal or no scarring. It does not stick to the wound during dressing changes, is easy to remove and change, and is suitable for use in all stages of various skin traumas and ulcers (early, middle, and late stages). It is highly effective, non-irritating, non-sensitizing, and a safe and highly effective topical treatment.

[0064] After years of screening and repeated clinical trials, the inventors discovered that by using calcium sulfate powder, zinc compound powder (selected from zinc oxide, calamine, or zinc carbonate), and mixing it with vegetable oil and beeswax to form a semi-solid paste, which can be spread onto non-woven fabric, a thin, soft medical wound dressing can be made. Applied to burns, scalds, mechanical injuries, and various chronic ulcers, it exhibits unique therapeutic effects superior to other topical preparations and dressing materials.

[0065] Through over thirty years of extensive clinical trials, it has been shown that the product can dissolve eschar and necrotic tissue from wounds, eliminating the need for eschar removal and skin grafting in deep burns. It also bidirectionally regulates the pH of the wound to neutral, releases analgesic and antibacterial functions, activates residual dermal papillae under the eschar, promotes in-situ regeneration and skin healing in deep wounds, and leaves little or no scarring. It does not stick to the wound surface; dressings are easy to remove and change; it is suitable for use in the early, middle, and late stages of various skin traumas and ulcers, with significant effects, no skin irritation, no sensitization, and is highly effective and safe.

[0066] The wound dressing of the present invention includes the following methods of use:

[0067] (1) Clean the affected area according to standard surgical procedures. Tear open the outer packaging of this product, take out the dressing, cut it to the size of the wound, remove the PET mesh covering the ointment layer and the transparent film supporting the back, apply the ointment to the affected area, and then pad it with gauze and adhesive strips for fixation, or wrap it with a bandage for fixation. Change the dressing once a day in the early stage, and change it every 2-3 days in the middle and late stages. In harsh environments or emergency situations, the affected area can be simply wiped and fixed with a bandage.

[0068] (2) When cleaning the wound for the first time after treating a burn, the blisters should be cut open to relieve pressure before applying this product. For deep second-degree to third-degree burns, applying this product will soften and liquefy the eschar. When changing the dressing, the softened eschar can be gently scraped off with a spatula before applying this product. After the wound has healed, this product can be applied several more times to promote skin regeneration and scab removal.

[0069] (3) For the treatment of severe bedsores, the black necrotic tissue should be removed first, and then this product should be applied. For the treatment of diabetic foot gangrene and occlusive arteriosclerosis foot gangrene, the black necrotic tissue of the limbs and toes should be removed under anesthesia. Suturing is not necessary. This product should be applied to the cut surface and allowed to heal on its own.

[0070] (4) For the treatment of gangrene in diabetic foot and occlusive arteriosclerosis foot, the large amputation (toe) fish-mouth suture procedure can be replaced with a small amputation (toe) dressing procedure. Only the black necrotic part needs to be removed, and the wound does not need to be sutured. Applying this product will cause skin regrowth and healing. For some larger ulcers with good blood circulation, amputation can be avoided. Applying this product alone will also allow the skin to grow back naturally and heal.

[0071] (5) For treating deep burns, where the entire skin layer is completely destroyed and the dermis is no longer present, simply applying this product until granulation tissue has fully grown may lead to excessive proliferation and the formation of thick, contracted scars. To avoid scar formation, the inventors use a "scraping and scraping therapy," where, when the granulation tissue in a deep wound protrudes above the skin surface, the excessively grown granulation tissue is scraped away with a curette down to the wound floor. The product is then applied as usual, and gauze is used for fixation or bandaging. This encourages the epithelium around the periphery to grow towards the center, preventing scarring. After the first scraping and scraping, the wound will noticeably shrink and flatten. Once the granulation tissue protrudes again, it is scraped away again, and the product is applied and bandaged. This process is repeated until the entire wound has healed. Generally, small, deep wounds only require one or two scraping and scraping sessions to heal without scarring. Some large, deep wounds require multiple scrapings to allow the surrounding epithelium to creep towards the center and cover the wound, achieving the goal of skin graft-free, scarless repair and healing.

[0072] Example 1

[0073] The present invention provides a method for preparing a multi-functional, high-efficiency, non-adhesive, and easily replaceable wound dressing, comprising the following steps:

[0074] 1) Heat the vegetable oil to boiling and keep it warm for 30-60 minutes;

[0075] 2) Add calcium sulfate, zinc compound, iron oxide, beeswax and petrolatum to the vegetable oil in step 1), stir well, let stand, and let it cool and solidify into a light red paste.

[0076] 3) Apply the paste obtained in step 2) evenly and under pressure onto the non-woven fabric to a thickness of 0.5-2 mm to obtain a light red dressing.

[0077] 4) Cover the paste-like dressing with mesh, place the plastic film layer on the back of the dressing, put it into a composite aluminum-plastic film packaging bag, and seal the packaging to obtain a multi-functional, high-efficiency, non-stick, and easily replaceable wound dressing.

[0078] The composition, by weight (100%), is as follows: 10% calcium carbonate, 15% iron oxide, 0.5% iron oxide, 20% vegetable oil (including camellia seed oil, peanut oil, flaxseed oil and rice bran oil in a mass ratio of 1:1:1:1), 20% beeswax, and the remainder is petrolatum.

[0079] Example 2

[0080] The present invention provides a method for preparing a multi-functional, high-efficiency, non-adhesive, and easily replaceable wound dressing, comprising the following steps:

[0081] 1) Heat the vegetable oil to boiling and keep it warm for 30-60 minutes;

[0082] 2) Add calcium sulfate, zinc compound, iron oxide, beeswax and petrolatum to the vegetable oil in step 1), stir well, let stand, and let it cool and solidify into a light red paste.

[0083] 3) Apply the paste obtained in step 2) evenly and under pressure onto the non-woven fabric to a thickness of 0.5-2 mm to obtain a light red dressing.

[0084] 4) Cover the paste-like dressing with mesh, place the plastic film layer on the back of the dressing, put it into a composite aluminum-plastic film packaging bag, and seal the packaging to obtain a multi-functional, high-efficiency, non-stick, and easily replaceable wound dressing.

[0085] The composition, by weight (100%), is as follows: 10% calcium carbonate, 15% iron oxide, 0.5% iron oxide, 20% vegetable oil (including camellia seed oil, peanut oil, flaxseed oil and rice bran oil in a mass ratio of 1:1:1:1), 20% beeswax, and the remainder is petrolatum.

[0086] Example 3

[0087] The present invention provides a method for preparing a multi-functional, high-efficiency, non-adhesive, and easily replaceable wound dressing, comprising the following steps:

[0088] 1) Heat the vegetable oil to boiling and keep it warm for 30-60 minutes;

[0089] 2) Add calcium sulfate, zinc compound, iron oxide, beeswax and petrolatum to the vegetable oil in step 1), stir well, let stand, and let it cool and solidify into a light red paste.

[0090] 3) Apply the paste obtained in step 2) evenly and under pressure onto the non-woven fabric to a thickness of 0.5-2 mm to obtain a light red dressing.

[0091] 4) Cover the paste-like dressing with mesh, place the plastic film layer on the back of the dressing, put it into a composite aluminum-plastic film packaging bag, and seal the packaging to obtain a multi-functional, high-efficiency, non-stick, and easily replaceable wound dressing.

[0092] The composition, by weight (100%), is as follows: 10% calcium carbonate, 15% iron oxide, 0.5% iron oxide, 20% vegetable oil (including camellia seed oil, peanut oil, flaxseed oil, and rice bran oil in a mass ratio of 1:1:1:1), 20% beeswax, and the remainder is petrolatum.

[0093] Example 4

[0094] This example illustrates the treatment of burns in a patient:

[0095] Patient: Mr. Li, male, 60 years old, from Zhejiang Province. Injury grade: third-degree, with a small amount of deep second-degree burns. While repairing electrical appliances with a colleague, the patient accidentally suffered electric shocks to his hands and face. He was treated with the wound dressing of this invention for 17 days, with 17 dressing changes. Result: Healed without scarring, normal skin texture, and normal function. See [link / reference]. Figure 2 .

[0096] A follow-up visit seven months later showed that the backs of the patient's hands had completely recovered to normal, with no scars and clear skin lines. This case demonstrates that even after deep burn wounds have healed and entered the recovery period, it is still necessary to continue applying Puji Ointment. This allows for multiple skin regenerations and scar-free repair, achieving a non-surgical cosmetic effect.

[0097] Example 5

[0098] This example illustrates a patient suffering from deep burns and frostbite.

[0099] Patient: Deng, 1 year and 5 months old, from Xiajiang County. The child accidentally scalded his right hand with boiling water. After the injury, a local clinic applied "Meibao" burn ointment to the wound. Due to the coldest part of winter, the burn was compounded by frostbite, resulting in swelling, deep necrosis, and a thick, hard eschar. The child also had a high fever for several days and cried inconsolably, leading to his transfer to the inventor for treatment. The inventor's wound dressing was used in combination with conventional burn treatment for 133 days, with 42 dressing changes. Result: The wound healed without scarring, skin texture recovered, and function returned to normal. See [link / reference]. Figure 3 .

[0100] This case involved a combination of third-degree burns and frostbite, with full-thickness skin necrosis extending to the muscle layer. After 40 days of treatment with the wound dressing of this invention, including 21 dressing changes, the wound healed completely, with scab removal and new skin regeneration. However, the surface of the new skin was uneven, and the subcutaneous tissue was relatively hard, potentially leading to contracture and scarring. To smooth the skin surface, soften the subcutaneous tissue, and prevent scarring, rehabilitative treatment was continued, with the wound dressing applied every 3 to 4 days. During subsequent scar-flattening treatments, the wound underwent multiple sheddings of old skin. ， New skin grew, subcutaneous tissue gradually softened, and the skin surface gradually smoothed. After 93 days of rehabilitation treatment and 21 dressing changes, the wound healed well, without scarring, with a smooth epidermis, soft subcutaneous tissue, restored skin lines, and normal function. The therapeutic effect was remarkable. This indicates that the wound dressing cleansing and regeneration therapy for deep burns not only promotes rapid healing in the early stages by cleaning the wound, removing scabs, and promoting tissue regeneration, but also achieves skin replacement, softening, and scar prevention and removal in the later stages, demonstrating a unique non-surgical plastic and rehabilitative effect.

[0101] Example 6

[0102] This example provides a case study of a patient's treatment for acetylene burns to both ankles:

[0103] Patient: Mr. Zeng, 54 years old, from Xiajiang County, suffered deep burns to the medial and lateral malleoli of his right foot and the medial malleolus of his left foot due to a ruptured acetylene gas pipe while operating a gas welding machine. He was immediately taken to the hospital for treatment. The hospital provided routine surgical anti-inflammatory and fluid replacement treatment but did not treat the wounds, only issuing "exposed moist burn ointment" for self-treatment. Due to the lack of improvement and increased burning pain, he was transferred to the inventor's clinic for treatment. Using the wound dressing of this invention in combination with conventional burn treatment, the treatment lasted 44 days, with 19 dressing changes. Results: The wounds were basically healed, the new skin was smooth, and there were no scars. See [link / reference]. Figure 4 .

[0104] Example 7

[0105] This example illustrates a child's deep second-degree burn on the dorsum of the foot:

[0106] Patient: Liu, 1 year and 6 months old, scalded his right foot with boiling water. He received anti-inflammatory injections and topical application of "Meibao" at a local clinic. The foot quickly swelled, oozed, developed thick blisters, became painful, and he cried and became restless. Due to the rapid worsening of his condition, he was transferred to the inventor for treatment. Using the wound dressing of this invention, he was treated for 10 days with 8 dressing changes. Result: Healed without scarring. See [link to invention]. Figure 5 .

[0107] Example 8

[0108] This example provides a case study of a patient's deep burn from concentrated nitric acid on the left forearm:

[0109] Patient: Mr. Wang, 31 years old, from Sichuan Province, accidentally spilled 95% concentrated nitric acid on his left forearm in a workshop. He immediately rinsed the wound with tap water for two minutes without further treatment and was rushed to the hospital. The county hospital advised immediate transfer to the First Affiliated Hospital of Nanchang University, but fearing the long distance and delay, he was transferred instead to the Burn Department of Ji'an Central Hospital. The department applied chitosan solution gauze to the wound and bandaged it. They planned to obtain pigskin dressings from the First Affiliated Hospital of Nanchang University and schedule escharotomy and skin grafting surgery later. At 1:10 PM, on a recommendation, he was transferred to the inventor for treatment, where he used the wound dressing of this invention. The total treatment duration was 73 days, with 46 dressing changes. Result: The wound healed, the new skin was soft and smooth, and function was normal. (See also...) Figure 6 .

[0110] Example 9

[0111] This example provides a case study of a patient with a deep burn on their right lower leg:

[0112] After the wound healed, blisters appeared on the wound surface. The patient's family, believing the injury to be minor, went to a local clinic for treatment. The clinic prescribed a self-made Chinese herbal powder and ointment for external application, along with intravenous anti-inflammatory medication. After one month of treatment, the eschar on the wound failed to fall off, and the surrounding swelling worsened. Due to the poor treatment effect and the patient's critical condition, they were transferred to the inventor for treatment. Injury grade: deep third degree. The wound dressing of this invention was used for 119 days of treatment, with 73 dressing changes. Results: The wound healed, the new skin was smooth, the scar was soft and flat, and function was normal. See [link to relevant documentation]. Figure 7 .

[0113] Example 10

[0114] This example provides a case study of treating a child with a deep burn on the left thigh:

[0115] Patient: Chen, 5 years and 6 months old, accidentally scalded the inner side of his left thigh with boiling water. He was immediately admitted to the county hospital for 11 days. Due to full-thickness skin necrosis and the severity of the injury, the hospital advised his family to transfer him to the First Affiliated Hospital for escharotomy and skin grafting. Through a referral, the family came to the inventor's clinic for treatment. The injury was classified as third-degree burn. The wound dressing of this invention was used in combination with conventional burn treatment for 104 days, with 47 dressing changes. Results: The wound basically healed, the new skin was smooth, and there were no scars. See [link / reference]. Figure 8 .

[0116] Example 11

[0117] This example provides a case study of treating a child's heel abrasion caused by a bicycle wire entanglement:

[0118] Patient: Liao, 2 years and 8 months old, accidentally put his right foot into the wheel of a moving bicycle, and his right Achilles tendon was scratched by the wire. After the injury, he was sent to Xiajiang County Traditional Chinese Medicine Hospital for treatment and was given Mebo burn ointment. Due to poor efficacy, he was discharged and transferred to the inventor for treatment.

[0119] The wound dressing of this invention was used in combination with conventional surgical treatment for 22 days, with 10 dressing changes. Results: wound healed without scarring, and function returned to normal. (See [link]). Figure 9 .

[0120] Example 12

[0121] This example provides a case study of the treatment of a severe ulcer on the left lower leg after venous flexion surgery:

[0122] Patient: Mr. Bian, 72 years old. He developed varicose veins in his left calf at age 40, which worsened annually. At age 60, he developed chronic ulceration on the lower segment of his right calf, which increased in size and depth each year, remaining unhealed for 7 years. Five years ago, he underwent ligation of the great saphenous vein in his left calf at a hospital. Post-operatively, the ulcer did not improve and continued to enlarge and deepen, becoming a black gangrenous ulcer. He then came to the inventor for treatment, using the wound dressing of this invention, changing the dressing every 2-3 days, as well as outpatient treatment combining traditional Chinese and Western medicine. The treatment lasted 180 days, with 70 dressing changes. Results: the wound healed, the surrounding tissue softened, and the skin color lightened. See [link to relevant documentation]. Figure 10 .

[0123] It is evident that the novel achievements of this invention have creatively given rise to "burn ecological medicine." It first proposes that even in deep second- and third-degree burns, dermal appendages remain beneath the eschar. By creating a favorable wound environment, damage can be buffered, losses can be mitigated, and regeneration and repair can occur. This manifests as early-stage buffering and wound protection, reversing the injury grade and resuscitating residual dermal papillae beneath the eschar; mid-stage autolytic debridement, eschar removal, and swelling reduction, promoting the proliferation of new granulation tissue from the residual dermal papillae; and late-stage hyperplasia of skin islands, epidermal regeneration, scar removal and skin replacement, morphological restoration, and functional recovery, achieving an innovative concept and treatment method that eliminates the need for eschar removal surgery and skin grafting. Guided by the burn ecological medicine theory of this invention, the inventors use "burn wound ecological therapy," which includes applying the product of this invention for buffering and wound protection, reversing the injury grade, resuscitating residual dermal papillae beneath the eschar, dissolving the eschar, and promoting in-situ regeneration. After the new granulation tissue grows excessively and protrudes above the skin surface, it is scraped off with a curette. This process is repeated until the wound heals by crawling from the surrounding epithelial tissue towards the center, resulting in an innovative technique that achieves scarless (micro) healing.

[0124] Extensive clinical data from repeated trials of deep burns demonstrate that the innovative technological achievements of this invention have achieved a major breakthrough in deep burn healing and repair without escharotomy, skin grafting, or (micro)scars. Once widely adopted, this will trigger a significant transformation in modern burn medicine.

[0125] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. An adhesive-free, easily replaceable wound dressing, characterized in that The wound dressing comprises a non-woven fabric layer, an effective component layer, a mesh layer and a plastic film layer, wherein the effective component layer is prepared from calcium sulfate, a zinc compound, iron oxide, vegetable oil, beeswax and vaseline. The effective component layer is prepared from 10%-25% calcium sulfate, 10%-25% zinc compound, 0.1%-0.5% iron oxide, 20%-40% vegetable oil, 10%-20% beeswax and the rest vaseline.

2. The non-sticking and easily replaceable wound dressing according to claim 1, characterized in that, The zinc compound is selected from one or more combinations of zinc oxide, malachite and zinc carbonate.

3. The non-sticking and easily replaceable wound dressing according to claim 1, wherein, The vegetable oil is selected from one or more combinations of camellia seed oil, peanut oil, flaxseed oil and rice oil.

4. A method of preparing a non-sticking, easily exchangeable wound dressing according to any one of claims 1 to 3, characterized in that The preparation method comprises the following steps: 1) heating the vegetable oil to boiling and keeping warm; 2) adding calcium sulfate, a zinc compound, iron oxide, beeswax and vaseline into the vegetable oil of step 1), stirring uniformly, standing and condensing into a light red paste; 3) uniformly pressing and spreading the paste of step 2) on the non-woven fabric to obtain a light red dressing; 4) covering the mesh on the paste of the dressing, placing the plastic film layer on the back of the dressing, putting into a composite aluminum plastic film packaging bag, sealing the opening and packaging to obtain a non-sticking and easily changed wound dressing.

5. The method of claim 4, wherein the adhesive is applied to the backing in a pattern of lines, dots, or a combination thereof. In step 1), the keeping warm time is 30-60 min.

6. The method of claim 4, wherein the adhesive is a pressure sensitive adhesive. In step 2), the thickness of the paste is 0.5-2 mm.

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