MXPA99005485A - Skin resurfacing recovery system - Google Patents

Abstract

This invention relates to methods of promoting the healing of skin wounds, products for promoting the healing of skin wounds and processes for making such products. More particularly, this invention relates to layered absorbent dressings which absorb wound exudate in conjunction with additional products for assisting the healing of wounds at each stage of wound healing, as well as methods of using these dressings and methods of making these dressings.

Description

RECOVERY SYSTEM FOR SKIN RECONSTRUCTION FIELD OF THE INVENTION This invention relates to an apparatus, compositions and methods for curing skin that has been treated with reconstruction techniques. More particularly, it refers to bandages, compositions and apparatuses that can be applied to the skin after reconstructive surgery, and which accelerate the healing process.

BACKGROUND OF THE INVENTION Cosmetic dermatology is currently experiencing explosive growth thanks to a growing population of patients and the expansion of options in procedures and practices that provide skin with a more youthful appearance. However, there is no current product or regimen that optimizes the healing environment of the skin after these advanced treatment procedures. Returning the skin to a functional barrier after laser reconstruction, deep chemical peeling and dermabrasion proceeds through three distinct phases: an initial inflammatory phase, followed by a proliferative phase and continuing through a remodeling phase. Each step evolves progressively in the subsequent step, finally leading to a daily maintenance regime.

BRIEF DESCRIPTION OF THE INVENTION The compositions, apparatus and methods of this invention provide a wound management system that meets the needs of both physicians and patients following cosmetic reconstruction procedures. This system is based on the mechanisms of wound healing. A primary and / or secondary bandage is applied to the skin that absorbs fluid and wound secretions after completing the treatment of the skin, during the initial inflammatory phase. During the next healing phase, the proliferative phase, another maintenance bandage is applied. During the remodeling phase, a barrier material is applied to preserve the barrier function of the healing skin. The benefits for doctors are: optimization of wound repair, minimization of patient confusion / anxiety, maximization of patient satisfaction. The benefits for patients are: increased comfort and control over their post-treatment management, development of their skin maintenance care program. The compositions, apparatus and methods of this invention can be used in the management of wounds, as well as in any situation where it is desirable to cover an area of the skin, particularly the facial area. Such situations may include treatments for facial skin such as laser reconstruction, facial peeling and facial tissue moistening. The compositions, apparatus and methods of this invention provide a progressive healing system that provides the optimum environment that makes it possible for the healing to proceed at a rapid rate, and meets the specific needs of the skin through each stage of healing. The products of this invention are easy to use in the patient's home and are very comfortable. According to the compositions, apparatuses and methods of this invention, the skin returns to a normal and healthy state approximately six days after having carried out the reconstruction treatment. In general, there are three main phases to return the skin to a functional barrier after the skin reconstruction procedures: (1) the initial inflammatory phase, which produces a large amount of fluid or wound secretions that must be effectively managed to maintain the optimal wound environment while providing patient comfort; (2) the proliferative phase, in which the epidermis is regenerated and the wound must be maintained at the optimum temperature and humidity to facilitate healing and minimize the discomfort of the patient and (3) restore the barrier properties of the skin. The methods and products of this invention solve all the patient's needs during each phase of the healing process.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES In accordance with this invention, a method, compositions and methods of manufacture for promoting wound healing and skin treatment are provided. The method of treating the skin comprises the following steps: (A) applying one of the following products to the skin: i) a system comprising at least the following layers: (a) a primary absorbent layer that faces the skin for the purpose of absorbing wound fluid or secretions during the initial inflammatory phase of healing to maintain the optimal wound environment and provide comfort to the patient; and (b) a secondary absorbent cover layer associated with said primary absorbent layer facing the skin, which is breathable and fixed to the face and the primary absorbent layer; said primary and secondary absorbent layers being applied for approximately 24 to 36 hours after the reconstruction surgery; or (ii) an absorbent layer having the characteristics of absorbing fluid from the wound without adhering thereto, and being sufficiently breathable to allow vapor to escape from the wound or site of the covered skin; (B) removing said cover layers and applying a maintenance layer that regulates the temperature and humidity of the wound environment during the proliferative phase of wound healing for approximately 24 to 36 hours after removing the primary and secondary absorbent layers; (C) removing said maintenance layer and applying a barrier material that minimizes the transepidermal water loss and increases the intercellular lipid fluidity of the skin during the phase in which the barrier properties of the skin are restored. One of the most important aspects of the methods and apparatus of this invention is the first bandage that can be placed over the desired area. This bandage must be highly absorbent, but breathable, allowing the secretions and / or moisture of the wounds to be extracted from the skin, but regulating the temperature and humidity of the skin. One of the preferred embodiments of the bandages of this invention may comprise two or more layers, a primary and a secondary absorbent layer. Alternatively, it may be a laminate or combination material incorporating a primary or secondary bandage. Preferably, when the bandage is composed of at least two discrete layers, the primary absorbent layer is composed of a material that is highly absorbent and foldable to conform well to the contours of the face. Most preferably, the primary absorbent layer is composed of a lyophilized alginate-collagen wound dressing. Most preferably, the primary absorbent layer is composed of Fibracol *, a lyophilized collagen-alginate wound dressing currently available from Johnson & Johnson Medical Inc. of Arlington, Texas. FibracoP is currently marketed for use in partial thickness wounds. The present inventors have found that it is extremely useful in handling the initial inflammatory stage of healing of reconstructed skin. The soft, light and collapsible matrix of lyophilized collagen and alginate provides immediate absorption of secretions after application. Since the primary bandage Fibracol absorbs secretions, it conforms to the contours of the face, creating an intimate protective layer over the naked dermis. The presence of collagen acts as a hemostat, increasing coagulation and the liberation of platelet repair enhancement peptides. By absorbing Fibracol secretions, it becomes a gel, confining the natural growth factors to the surface of the injured skin, facilitating the regeneration of the skin. The absorbent layer composed of Fibracol * absorbs up to 70% of its weight of secretions. The primary absorbent layer can also be composed of a layer of hydrogel, ointment or any other wound dressing or skin treatment composition known to those skilled in the art. Preferably, the primary absorbent layer is associated with a secondary absorbent layer that acts as a cover for the primary absorbent layer. The breathable absorbent cover is preferably a soft and flexible covering that maximizes the benefits of the primary absorbent layer. It must be ergonomically designed to conform to the face and join the primary absorbent layer.

The breathable absorbent cover assists the primary absorbent layer in fluid handling and creates an optimal wound environment that facilitates epidermal regeneration. At the end of the inflammatory phase, the bandage can be removed without pain or additional injury, and the facial skin is ready to proceed to the regeneration phase of the healing. The breathable secondary absorbent layer allows water vapor to pass therethrough, while avoiding moisture leakage, thereby substantially preventing the skin from drying out while maintaining a healthy exchange of water vapor and air. to the wound. The secondary absorbent layer also aids in the easy removal of the primary absorbent layer after completing the first stage of curing. The secondary absorbent layer which may be used in conjunction with said primary absorbent layer or as a primary absorbent layer per se is preferably a laminate composed of at least one absorbent material which may be a nonwoven fluff pulp or fibrous material and thus less a thermoplastic or thermofusable material. The secondary absorbent layer must be breathable and therefore porous. Alternatively, the secondary absorbent layer may be composed of two or more materials that have been heat sealed, embossed and perforated (hereinafter, "perf-enhanced") to provide pores and depressions in a mixed layer. The absorbent material must contain fibers that can be fused by heat during the embossing process in the thermofusable absorbent layer. It can be provided as a wadding or as a nonwoven fabric material. The perf-enhancement procedure creates "cavities" or depressions in the mixed product, as well as perforations, grooves, openings, stretches or fractures on the side walls of the cavities. The slots or openings allow the liquid to flow easily into the absorbent structure, while the closed bottom of the walls prevents the fluid from flowing back. The grooves or apertures of the enhancements of the products of this invention can be seen in Figures 5a, 5b and 5c. The primary and secondary absorbent layers must be foldable and conformable to be able to conform to the three-dimensional topography of the face, for example, without causing additional damage to the delicate tissue being cured. Preferably, the central absorbent material contains heat-fusible fibers that can be bonded when heated with films placed on a side facing the body of the core material and, optionally, on the side facing outward of the core material. The fibers can be two-component fibers, for example, composed of a polyester core with a polyethylene shell or a polypropylene core with a polyethylene shell, or similar bonding fibers known to those skilled in the art, as long as they can be fused by heat with other materials and maintain their structure. Said fibers are capable of being bonded to one another and to the surfaces of the film and maintain the integrity of the primary and secondary absorbent layers. In addition, the heat-fusible fibers allow holes to be made in the layers to provide openings that can be sealed by heat for the nose, mouth and eyes, creating a mask to apply the bandage to the face. The openings in the mixed bandage can be joined and sealed with heat and form barriers for fluids that are absorbed in the bandage, thus preventing them from flowing into the eyes, nose and mouth, and providing a comfortable bandage for the patient. The absorbent core layer of the secondary absorbent layer of the products of this invention preferably contains lint pulp and a bond fiber. Preferably, the absorbent laminate layer should contain from about 5 to about 40% heat-fusible bond fiber, most preferably from about 20 to about 25%. The basis weight of the absorbent laminate layer should be approximately 50 to approximately 200 grams per square meter, most preferably about 100 to 150 and more preferably about 110 to about 125. The density should be from about 0.03 to about 0.2 g / cc, most preferably about 0.07 to about 0.10 and more preferably about 0.07 to about 0.09. g / cc, preferably, Concert 120.899, available from the Concert Company of Thurso, Canada. The side facing the body of the secondary absorbent mixed layer should preferably be laminated on its side facing the body to an acquisition surface. This acquisition surface is preferably a relatively non-stretchable film that can be easily perforated. Preferably, the film should have perforations in a pattern containing a straight edge, although they may be in the form of ellipses or arcs, as long as they provide grooves instead of macropores. The acquisition surface provides a means through which fluid and wound secretions can be acquired by the central absorbent layer and removed from the immediate vicinity of the skin. This helps and speeds up the healing process without adhering to the healing skin and without causing injury after removal, as would a fibrous absorbent wadding or non-woven material. Preferably, a mixed film containing polyethylene and ethylene vinyl acetate from about 25.9 to about 38.1 microns thick prior to embossing can be used. The film may have a thickness of about 76.2 to 101.6 microns, preferably 88.9 microns as supplied, since the thickness increases after enhancement by the manufacturer. Preferably, the acquisition surface that gives the body is a co-extruded polymer film, most preferably polyethylene / ethylene vinyl acetate, such as XP-1167B, commercially available from Edison Plastics of Edison, New Jersey. Elongation at film break in the machine direction = 425 +/- 225 and in the transverse direction 685 +/- 155 according to ASTM D882. The resistance to tension @ 25% is: DM 640 +/- 152, DT 470 +/- 85. These numbers are for a movie of 25.4 microns. Other materials that can be used on the mixed absorbent product are: Reticulon * perforated film of 33.90 g / m2 of PGI and Enka nonwoven fabric containing heat-fusible fibers and having a weight of about 16.95 to about 67.81 g / m2, commercially available from PGI of Dayton, New Jersey. The side facing away from the secondary absorbent mixed layer must be associated with a layer of barrier film. This layer is preferably laminated to the absorbent material. It must be porous, so that moisture can escape through it away from the skin. Preferably, the barrier film layer should be monolithic (e.g., polyurethane or polyester or the like) or microporous, so that the layer is breathable. The mixed absorbent layer can be laminated to the barrier film layer using heat, if both the film layer and the components of the absorbent layer are thermofusable. Alternatively, they can be laminated with a hot melt adhesive sprayer. Most preferably, a microporous and breathable film should be used. The film should have a weight of about 20 to about 40 gmc, most preferably about 25 to about 30 gmc. The Moisture Vapor Transmission Rate (MVTR) should be in the range of about 500 to about 7500 g / m2 / day, most preferably about 750 to about 4000 g / m2 / day and more preferably about 1000 to about 3000 g / m2 / day, tested using the test method ASTM E96-90 or E96-E of Clopay of Cincinnati, Ohio. Polyurethane and other breathable films having the appropriate MVTR can also be used in the mixed product of this invention. Most preferably, the film must be a microporous polyethylene film. The products of the invention currently tested used a microporous polyethylene film known and available as Br-200 or Br-300 from Clopay of Cincinnati, Ohio. Most preferably, the mixed layers of the secondary mixed layer should be laminated using a heat-laminated adhesive, in an amount of about 0.5 mg / 6.54 cm2 to about 3.5 mg / 6.54 cm2. Most preferably, it should be used in an amount of about 1.75 to about 2.25 mg / 6.54 cm2. Any heat fusion adhesive known to those skilled in the art should be effective in adhering the layers. The thickness of the complete mixed absorbent product should be from about 1.9 mm to about 2.54 mm to 0.00703 kg / cm2. The MVTR of the complete absorbent mixed product should be approximately 500 to 3000 g / m2 / day. Most preferably, it should be from about 1000 to about 2000 g / m2 / day using the ASTM E96-E test method from Clopay of Cincinnati, Ohio. The mixed absorbent product of this invention can be used either as a secondary bandage in conjunction with a primary bandage such as a hydrogel, ointment or other similar type of bandage material. As an alternative, it can be used by itself as a primary bandage alone, since it incorporates the handling characteristics of the wound environment and the transpiration capacity characteristics required by the products of this invention. In addition, it can function as a cover for any skin treatment based on solvents, promoting the penetration of the treatment to achieve the desired effect. Treatments for the skin may include peels, moistening using alpha hydroxy acids, humectants and botanical rejuvenants and the like to improve skin penetration and protection of clothing and the environment from the skin treatment compositions. The mixed laminate product of this invention can also be used in many types of absorbent products, including wound dressings, panty liners, sanitary napkins, incontinence products, diapers and the like. The absorbent blended product of this invention can be obtained when two or more materials are fed through a pair of heated cylindrical lifting rollers having projections or knuckles (e.g., diamond or hexagonal) in engaged arrangements. The mixed product has at least one material that is thermoplastic and at least one layer is a nonwoven / absorbent material. The resulting mixed product is a highly flexible, soft and conformable three-dimensional laminate with elevated and depressed areas on the surface. Elevated and depressed areas effectively create cavities on both surfaces of the mixed product. The perf-enhancement procedure creates perforations, grooves, openings, stretches or fractures on the "side walls" of the cavities. The slots or openings allow the liquid to flow easily into the absorbent structure, while the "closed" bottom of the wall prevents the return of the fluid. Perf-enhancing procedures such as that described herein are also set forth in the U.S. patent. No. 5,242,435 (Murji and Brisebois) and in the US patent. 3,817,827 (Benz) which are incorporated herein by reference. The perf-embossing process for manufacturing the secondary absorbent layer of the products of this invention is carried out as follows. Referring to Figure 6, a roll 100 containing a polyethylene / ethylene vinyl acetate film 105 is unwound on a roll 200 containing an absorbent layer 205, such that the ethylene vinyl acetate side of the film 110 is contiguous. with the absorbent layer 205, as shown in Figure 6. The film 105 and the absorbent layer 205 are wound under a calibrated roll 300 and on an upper perf-embossing roll 400. The upper perf-embossing roll 400 contains projections of perf-enhancement 405 which are contiguously coupled with a lower perf-enhancement roller 500. Both rollers contain projections 405 and 505 or teeth in the form of a polyhedron such as a square, rectangle, diamond or the like. Both rolls are heated to a temperature of about 65.5 ° to about 107.2 ° C. Preferably, the upper roller 400 is heated to a relatively higher temperature compared to the lower roller 505, ie, within a range of about 79.4 ° to about 107.2 ° C; the lower roller 505 is relatively colder, preferably heated to a temperature of about 65.5 ° to about 93.3 ° C. The teeth or projections 405 and 505 are aligned such that, through the film and absorbent layers, they engage the surfaces of the opposing rolls, ie, the teeth 405 make contact with the surface 510 and the teeth 505 contact the the surface 410. The projections or teeth 405 and 505 should not contact each other while the rollers 400 and 500 rotate. The rollers 400 and 500 should rotate in opposite directions, as shown by arrows 420 and 520. Preferably, the interference, i.e., the overlap between the teeth should be from about 2,286 to about 2,794 microns, with a maximum of about 3,429 microns. apart. Referring to Figure 7, the perf-enhancement step creates a laminate 600 in which the absorbent layer and the film are fused together. After the perf-enhanced step, a heat fusion applicator 700 applies heat fusion adhesive to the side of the absorbent layer of the absorbent laminate 600 that faces outward from the film portion. The absorbent laminate containing adhesive 600 is passed under a weighted roll 800 and a breathable barrier film 805 is applied which is laminated to the absorbent layer, creating the laminated secondary absorbent layer of this invention. The combination of the perf-enhanced absorbent mixed layer, which has a three-dimensional configuration, with the relatively flat barrier film layer results in the creation of "void volume pockets", i.e., air areas located in the spaces created by the raised surface of the absorbent layer that can provide air circulation, store liquids and provide places in which particles of material, such as superabsorbents, can be placed in the secondary layer.

The secondary absorbent laminate layer can be "die-cut" to produce a wide range of personal care products and wound or skin care products that require fluid handling, eg, face masks, panty-masks, towels sanitary, incontinence products, bandages for wounds and similar. For example, with reference to Figure 8, the absorbent laminate layer can be cut into a face mask 900. The secondary absorbent layer is preferably configured in the form of a face with openings for the eyes, nose and mouth. The secondary absorbent layer conforms to the facial contours and adheres to the primary absorbent layer, maintaining its position on the face for approximately 24 to approximately 36 hours. It can be held in place with straps or retention bands, as shown in Figure 1. Figure 2 demonstrates a mask according to the method of this invention, which allows the formation of a wound dressing from a single flat sheet of secondary absorbent laminate that can be folded to create a conformable and three-dimensional product. The openings around the edges and the openings of the eyes, nose and mouth can be sealed by heat to prevent spillage of fluid and provide comfort to the patient. Slotted lines 15 provide fold guides so that the doctor or patient can bend and secure the mask around the face to conform to the shape of the patient's face. It can be secured with a simple band or tape. You can cut a piece for the nose that can be placed with tape over the opening for the nose to prevent the lower skin from drying out. Another method of assurance is as follows. This can be achieved by using three moldable strips that are placed over the forehead, over the bridge of the nose and around the lower jawline. This moldable or foldable material must conform to the contours of the face, making it possible for a bandage or cover to maintain direct contact with the facial surface. The strips must be joined to each other in a way that ensures that they act, independently, as a unit. This fixation can be a rivet or a hinge that allows movement to duplicate the movement of the face and jaw. A flexible and elastic material such as a non-woven or woven belt is attached to the unit to secure the device to the head. The elastic and flexible strap can be attached to the unit in one or more positions ensuring that the unit continues to conform to the contours of the face. The strap can cover the entire head or it can be designed in a way that it hangs behind the ears. Another embodiment provides a compressible foam supported on a rigid or semi-rigid structure. The support structure can be designed to encompass the perimeter of the face with a bridge that extends across the bridge of the nose. The unit can be fixed or hinged to allow movement of the jaw. The foam must be compressible to retain a bandage or cover in direct contact with the surface of the skin. A flexible and elastic material such as a non-woven or woven belt is attached to the unit to secure the device to the head. The elastic and flexible strap can be attached to the unit in one or more positions ensuring that the unit continues to conform to the contours of the face. The strap can cover the entire head or it can be designed in a way that it hangs behind the ears. After a period of approximately 24 to 36 hours, the initial wound dressing composed of the primary and secondary absorbent layers or the secondary layer itself is removed, as the skin will have entered the secondary phase of returning the skin to a functional barrier after the reconstruction, the proliferative phase. During this phase, epidermal regeneration is the main goal. Wound management during this phase includes providing optimum temperature and humidity to facilitate healing and minimize patient discomfort. At the beginning of phase 2, the wound secretes a small amount of fluid that must be absorbed; At the end of phase 2, the healing environment of the wound is drier. For the healing phase, a maintenance layer must be applied to the skin. Preferably, this maintenance layer is composed of a hydrogel mask that helps optimize epidermal migration and proliferation. The hydrogel mask is preferably composed of a matrix of polyethylene oxide and water intertwined to form a hydrogel. This flexibility and shape engineering produce flexibility and conformation to the contours of the face; cooling and tranquilizer after application. It also acts as a "skin substitute", replacing the barrier properties during epidermal regeneration and protecting the neoepidermis before maturation. The maintenance layer should be lightweight and should be able to cool and soothe the skin. Preferably, it absorbs up to 3 times its weight in secretions. It must also conform and adhere to the facial contours without an adhesive. The maintenance layer should preferably create an optimized environment for epidermal proliferation, migration and maturation, making it possible for the cure to proceed at a rapid rate, and it must be capable of being removed without disturbing the regenerated epidermis. Preferably, the maintenance layer should be held in place with a bandage retaining strap and may appear as shown in Figures 2 and 3. Figure 2 illustrates a top facial maintenance layer and Figure 3 illustrates a maintenance layer lower facial The maintenance layer should be retained on the skin for approximately 24 to approximately 36 hours, after which it should be removed. The final stage of healing after laser reconstruction, deep chemical peeling and dermabrasion includes restoring the barrier properties of the skin. Barrier materials should be applied to the skin in this healing phase to help the skin re-establish its barrier properties. Preferably, the barrier materials used are composed of wetting compositions. High glycerin humectants, for example, have proven to create a pseudo barrier, minimizing the loss of transepidermal water and increasing intracellular lipid fluidity. They have also been shown to stabilize the double layer of lipids, making it possible to restore the barrier function of the stratum corneum. Most preferably, an oil-free emollient and concentrate containing 40% glycerin is used to create a pseudo-barrier, protecting the neoepidermis and minimizing transepidermal water loss. A small amount of such cream is applied twice a day for five days to complete the acute healing program and the patient's transition to a maintenance skin care regimen. Most preferably, said barrier material is the Norwegian formula hand cream, a commercially available fragrance-free formula from Neutrogena Corporation, Los Angeles, California. Preferably, the barrier material creates a pseudo barrier to help avoid excessive loss of transepidermal water. It maintains increased levels of moisture in the skin for 17 hours or more to promote comfort and healing, and helps preserve the double layer of lipids to make possible the restoration of the skin's barrier function. The barrier material must create an osmotic environment that is not a bacterial growth host, and normalize the desquamation. Preferably, a kit containing the compositions and apparatus of this invention can be assembled as a kit for use by a physician, containing the following components: 1 set of lyophilized collagen dressings Fibracol (3 each) 1 absorbent cover for Fibracol 1 (or potentially two) bandage retention band 1 polyethylene oxide hydrogel (PEO) mask 1 tube (2.5 oz) of healing cream Resurface 1 tube (2.0 fl oz) of extra gentle cleanser 1 sample tube (0.25) fl oz) of Neutrogena Moisture SPF15 1 patient instruction leaflet 1 doctor's letter (to the patient) 1 set of medical packaging insert The following examples serve to illustrate, but not limit, the scope of the apparatus, procedure and compositions of this invention.

EXAMPLE 1 A face mask according to this invention was manufactured as follows. A commercially available polyethylene / ethylene vinyl acetate coextruded film was obtained as XP-11679B from Edison Plastics of Edison, New Jersey, an absorbent wadding containing a hot melt bicomponent fiber having a polyethylene cover and a polyester or polypropylene center , available as 120,899 Concert from Thurso, Canada and a breathable polyethylene film available as Br-300 from Clopay of Cincinnati. The layers of film and wadding were perf-enhanced as follows. A roll containing the polyethylene / ethylene vinyl acetate film was unwound on a roll containing an absorbent layer, such that the ethylene vinyl acetate side of the film gave the absorbent roll. The two layers were wound around a top perf-enhanced roller. The upper perf-embossing roller was contiguous to a lower prof-embossing roller. Both rollers contain projections or teeth in the form of a hexagon. Both rolls are heated to a temperature of about 65.5 to about 107.2 ° C. The upper roller was heated within a range of about 79.4 ° to about 107.2 ° C; the lower roller was heated to a temperature of about 65.5 ° to about 93.3 ° C. The distance between the enhancements made on the layer was from about 2,286 to about 2,794 microns. After the perf-enhancement step, heat-melting adhesive was applied to the side that faces away from the absorbent center (i.e., the side facing away from the film that faces the face becoming the acquisition layer at the mixed product completed) and a breathable barrier film was applied and laminated thereto. The photographs of the film enhanced with the 20X magnification roller to see the enhancements and perforations better, are shown in Figures 5a, 5b and 5c. The slotted openings are apparent in the figures. These slotted openings allow the fluid to be absorbed directly into the absorbent center of the laminate without allowing excessive rewetting. The physical characteristics of the laminate are shown in table 1 below. After lamination and perf-embossing, the laminar unit was cut to form a face mask 900 as shown in figure 8. After cutting, the mask piece should be sealed and slotted as shown in figure 9 The sealing should be carried out around the periphery 10 of the mask, as well as in the openings 20 and around the periphery of the nose piece 30. The mask must then be grooved with at least four straight lines 50 in points. equidistant from the perpendicular axis 40 and parallel to the perpendicular axis 40. The slotted lines can actually be sealing lines as well; as long as they serve to weaken the laminate in areas so that bending occurs more easily than in other areas of the batting. Slotted lines 60 can be made at an acute angle to the perpendicular axis 40. The slotted lines 50 and 60 allow the mask to be easily bent and conform to the three-dimensional configuration of the face. Folds can be made along the grooved lines 50 by folding the grooved lines further away from the perpendicular axis 40 either towards the side facing the body of the mask or towards the side facing away from the mask, pivoting the material along the innermost grooved line. Also, the mask can be bent to make a clip and cause the mask to be in the form of a three-dimensional configuration along the slotted lines 60. The slotted lines 65 also provide the means to create a "clip" or fold in the mask and form a three-dimensional structure. The mask can be adjusted accordingly in size to conform to the size and shape of the patient's head. Bending patterns such as those mentioned above can be found in Figure 10. The nose piece 35 can be detached and adhesively placed on the surface facing away from the mask on the reference line 70, as shown in FIG. length of the perpendicular axis 40 and centered between the holes for eyes 80.

TABLE 1 Physical characteristics of the laminate for facial mask Feature Measurement VROM method. STD Test units MVTR capacity 1292 1273 253 G / m2 / day transpiration Flexibility Fold 4032-82 modified circular Top 175 24 Peak load 5g Bottom 183 23 Peak load 5g Speed Speed 16140-9 80 34 Ml / min critical absorption ( Synthetic wound secretion) W78005 Time Rate 20 5 seconds absorption penetration (synthetic menstrual flow) Test Capacity 135 saturation absorption (synthetic wound secretion) In general, the flexibility of the mixed product should be from about 100 to about 250 g, as measured by the Modified Circular Flex test, most preferably from about 150 to about 225 g and more preferably from about 170 to about 190 g. The Modified Circular Flex Test is the Circular Flex Test number ASTM 4032-82 that has been modified as follows. A piston having a radius of 42 mm, an Instron compression cell of 2000 g and a reversible load cell of 500 kg are used. The specimens are conditioned by leaving them in a room that is at 21 ± 1 ° C and 50 ± 2% for a period of 2 hours. The specimens are cut into two specimens of 25.8 cm2 in vertical portion. The specimen is placed on the compression cell plate and centered so that the plunger descends at a speed of 50 cm per minute per full stroke length in the middle of the specimen. The plunger descends, bending a circular portion of the specimen and ascends, leaving the surface of the specimen. The numerical values of the test results are generated by the SINTECH TESTWORKS FOR WINDOWS (MTX) program. The MVTR was measured using the ASTM E96-90 or E96-E test method from Clopay of Cincinnati, Ohio. The mixed product should have an absorption rate of from about 50 to about 100 ml / min, most preferably from about 75 to about 85 ml / min using synthetic wound secretion having a viscosity similar to that of wound secretions (about 5%). -7 centipoises). The mixed product should have an absorption rate of about 10 to about 30 seconds using viscous synthetic menstrual flow having a viscosity of about 30-13.5 centipoise, most preferably about 15 to about 25 seconds. The absorption capacity should be at least about 10 g, most preferably about 120 g.

EXAMPLE 2 The effectiveness of a wound management regimen in accordance with this invention was evaluated to return the skin to its normal function after reconstruction procedures. Several variables were measured that included: production of secretion, initiation of epithelization, epithelization speed, cosmesis of the wound, ease of use, yield and effectiveness of the product, presence of microbial flora, presence of unexpected erythema, inflammation, infection and irritation. . Eighteen female subjects aged between 35 and 65 were recruited in the evaluation. The study was carried out as follows: all wounds were handled in a similar manner, with the three-step system of this invention. Immediately after the surgery, the treated skin of the subject was covered with a wound dressing FIBRACOL * over the entire face. The FIBRACOL * wound dressing was covered with an absorbent, breathable and waterproof cover and held in place with a coated plastic film securing device, supported by an open cell foam, for thirty six to forty and eight hours (step 1).

After this period, the bandage was removed and the face was covered with a NEUTROGENA® reconstruction gel on the entire surface, covered with a waterproof absorbent layer, breathable, primary and secondary absorbent, and held in place with a coated plastic film securing device, supported by an open cell foam, for twenty-four to thirty-six hours (step 2). On day 3 after surgery, the NEUTROGENA® absorbent center and reconstruction gel were removed. The face was washed with water and extra gentle NEUTROGENA® cleanser. The researcher then determined if the skin was completely epithelialized or if another wound dressing was required. If the skin was not epithelialized, the NEUTROGENA® reconstruction gel (a hydrogel skin cream available from the North Amercian Sterilization and Packaging Company of Franklin, NJ 07416) was reapplied and covered with another absorbent layer for another twenty-four hours. After complete epithelialization, the subject was applied a thin layer of the NEUTROGENA® reconstruction cream (step 3). The procedure of skin cleansing and barrier application was followed six times, separated evenly throughout the day for three consecutive days and nights. After this regimen, the researcher determined whether or not the skin of the face had completely regenerated. If the wound had not healed completely, the treatment was continued for a period determined by the investigator that did not exceed seven days. The subject returned the last day of the extension period to document complete epithelialization. If the skin had healed completely, the subject began a regimen of cleansing and moisturizing normal skin throughout the rest of the study. The subject returned during the second week and the fourth week after surgery for a follow-up visit and an exit study evaluation. The study concluded upon completion of the four-week follow-up visit. Test items included collagen-alginate wound dressing FIBRACOL *, product code 2495, available from Johnson &; Johnson Medical, Inc. of Arlington, Texas as the main bandage. This wound dressing was covered with a water absorbent and breathable secondary absorbent mixed product according to this invention during the first 48 hours after surgery. Neutrogena® reconstruction gel, a hydrogel skin cream available from the North American Sterilization and Packaging Company of Franklin, NJ 07416, was applied and covered with a waterproof and breathable absorbent secondary bandage according to this invention that was applied on days 2 and 3 during step 2 of the method. NEUSURFACE HEALING OINTMENT *, manufactured by Enterprises ¡mportab Inc., Claire, Quebec, Canada, was applied to reconstructed skin exposed to air on days 3 to 6 after operation without the mixed absorbent cover. RESURFACE HEALING CREAM *, available from Neutrogena Corporation of Los Angeles, California was applied to the reconstructed skin from day 6 to 12 after the operation. All subjects underwent a full-face laser reconstruction procedure. All patients included in the study had Ultra-pulse CO2 or Ultra-pulse CO2 and Erblum / YAG laser procedures. The determinations of the wound dressings were made by the designated study personnel at each visit until the complete regeneration of the skin by the investigator was observed. The bandages were evaluated for the following parameters: Appearance 5 = pristine 4 = slightly dirty 3 = slightly dirty, limited to 1 or 2 areas 2 = moderately dirty, full surface 1 = extensively dirty Absorption of secretion 5 = no secretion present 4 = minimal secretion, with additional capacity 3 = moderate secretion with complete saturation but without formation of channels 0 runoff 2 = moderate secretion with slight channel formation and runoff 1 = excessive secretion with formation of channels and moderate to strong runoff Union 4 = all sides joined 3 = one side exposed but the wound not exposed 2 = two sides detached but the wound not exposed 1 = two or more sides detached with exposure of the wound Wound pain during use 5 = no pain 4 = minimal pain, no distraction 3 = moderate pain, noticeable during day 2 = moderate pain causing distraction 1 = severe pain requiring pain medication After the removal of the device by the subject, under the supervision of the appropriate study personnel, the following parameters were assigned to the wound repair device: Ease of removal 5 = no effort 4 = minimal effort 3 = difficult 2 = more difficult (removal disturbed by product separation) 1 = extremely difficult Pain associated with removal 5 = no pain 4 = minimal pain, no distraction 3 = slightly distracting pain 2 = moderate pain, causing distraction 1 = severe pain Additional injury after removal 5 = no additional injury 4 = minimal, punctate bleeding 3 = minimal, diffuse bleeding 2 = moderate, punctate or diffuse bleeding 1 = severe blood discharge Epithelialization 5 = the wound is completely healed, bandage is not required 4 = the wound is epithelialized and does not require a bandage 3 = the wound is more than 75% epithelialized 2 = the wound is more than 50% epithelialized 1 = the wound is more of 25% epithelialized, appearance of epithelial islands 0 = no presence of epithelial islands A primary statistical analysis of a variation analysis conducted the number of days until complete epithelialization was performed to test the hypothesized equivalence of the management system versus control therapy. If the equivalence in time to complete epithelialization is rejected, then a suitable multiple comparison technique is established to evaluate the relative effectiveness of the different paired bandages. * A two-sided level of significance will be used. The subjective evaluations of the functionality of the bandage and appearance of the wound were examined descriptively. The average or median performance profiles were presented graphically. The evaluations that visually discriminate between the bandages were further examined. The results of the clinical test are established in tables 1 and 2 below: TABLE 2 Regeneration of the skin during the test Epithelialization score Percentage of subjects who achieved the score POD 2 POD 3 POD 4 POD 5 POD 6 POD 7 > 25% 28 epithelialized > 50% 39 epithelialized > 75% 6 100 epetelialized 100 Not required 0 94 100 17 bandage 100 Regeneration 0 0 83 complete 100 N = 18 SQUARE 3 Performance of the mask for the face in the clinical test Characteristic Post operative day Post operative day 3 STD score Absorbence score 1.9 1 3.4 1.0 Wound protection 3.8 1 4.3 0.9 Pain protection 4.6 0.9 4.8 during use 0.5 During removal 4.6 0.6 4.8 0.4 Adaptation 2.7 1.2 2.7 1.0 Appearance of the wound 4.3 0.4 4.5 0.5 Score: 5 = excellent, 4 = very good, 3 = good, 2 = poor, 1 = poor N = 20

Claims (22)

NOVELTY OF THE INVENTION CLAIMS

1. - A method for promoting skin healing comprising the following steps: (A) applying a primary absorbent layer that gives the skin, to the skin of a mammal having a wound, said primary absorbent layer that gives the skin absorbs secretions of wounds during the initial inflammatory phase of wound healing, and said primary absorbent layer that gives the skin has the characteristics of absorbing fluid from the wound without adhering to it and is also sufficiently breathable to allow the steam escapes from the wound or place of the covered skin, (B) after concluding the initial inflammatory stage of the wound healing, removing said primary absorbent layer that gives the skin and applying a maintenance layer that regulates the temperature and humidity of the wound environment during the proliferative phase of wound healing; and (C) after completion of the proliferative phase of wound healing, removing said maintenance layer and applying a barrier material that minimizes the transepidermal water loss and increases the intercellular lipid fluidity of the skin during the phase in which the barrier properties of the skin are re-established.

2. A method according to claim 1, further characterized in that step (A) further comprises applying a secondary absorbent layer that is transpillable.

3. - A method according to claim 1, further characterized in that said primary absorbent layer comprises a mixed laminate comprising an acquisition surface that gives the skin an absorbent center associated with it and a porous and breathable layer that gives out .

4. A method according to claim 3, further characterized in that said mixed laminate comprises a perf-enhanced structure.

5. A method according to claim 1, further characterized in that said maintenance layer comprises a layer of hydrogel.

6. A method according to claim 1, further characterized in that said barrier material comprises a skin moisturizing composition.

7. A method according to claim 2, further characterized in that said primary absorbent layer comprises a lyophilized collagen-alginate wound dressing.

8. A mixed absorbent product comprising: (a) an acquisition surface that gives the skin comprising a film that is capable of being perforated without substantial stretching, said acquisition surface that gives the skin a side that gives to the skin and one side that faces outwards; (b) an absorbent center associated contiguously with said acquisition surface that gives the skin and its side that faces outwards, said absorbent center has a side that gives the skin and a side that gives out and (c) a layer of barrier film associated contiguously with said absorbent center on the outward side of said absorbent center, said layer of barrier film is breathable, said mixed absorbent product having a peak load (5g) according to the Circular Flexure Procedure Modified from about 150 to about 250 g, and wherein said mixed absorbent product contains empty volumes that are available to contain fluids.

9. A mixed absorbent product according to claim 8, further characterized in that said mixed material is laminated.

10. A mixed absorbent product according to claim 8, further characterized in that said mixed product is perforated and enhanced, creating perforations and enhancements in said mixed product, wherein said perforations are separated at a distance of approximately 2.28 to 3.43 microns.

11. A mixed absorbent product according to claim 8, further characterized in that said acquisition surface comprises a polyalkylene polymer film, a coextruded polyethylene / ethylene vinyl acetate film or a nonwoven fabric comprising hot melt fibers having a base weight from about 16.95 to about 67.81 g / m2.

12. A mixed absorbent product according to claim 8, further characterized in that said absorbent center comprises a non-woven fabric or wadding.

13. - A mixed absorbent product according to claim 12, further characterized in that said non-woven fabric or batt comprises about 5 to about 40% heat-fusible bond fiber and wood pulp fluff.

14. A mixed absorbent product according to claim 12, further characterized in that said absorbent center has a basis weight of about 50 to about 200 g / m2.

15. A mixed absorbent product according to claim 12, further characterized in that said absorbent center has a basis weight of about 0.03 to about 0.2 g / cc.

16. A mixed absorbent product according to claim 8, further characterized in that said layer of barrier film comprises a porous film.

17. A mixed absorbent product according to claim 8, further characterized in that said layer of barrier film has a Moisture Vapor Transmission Rate of from about 500 to about 7500 g / m2 / day.

18. A mixed absorbent product according to claim 17, further characterized in that said Moisture Vapor Transmission Rate is from about 100 to about 300 g / m2 / day.

19. A mixed absorbent product according to claim 16, further characterized in that said layer of barrier film comprises a microporous coextruded polyethylene / ethylene vinyl acetate film.

20. A process for manufacturing a mixed absorbent laminate, comprising the following steps: (a) providing an acquisition layer and a contiguous absorbent central layer having one that faces the acquisition layer and one side that outwardly, which are able to join together when heat is applied; (b) piercing and enhancing said acquisition layer and said adjoining absorbent core layer at a temperature of from about 65.5 to about 107.2 ° C, thereby melting said absorbent core layer to said acquisition layer on the side facing the layer of absorbent. acquisition of said absorbent core layer; (c) applying an adhesive to the side that gives out of said absorbent core layer and laminating a breathable barrier film to the absorbent core layer.

21. A face wound dressing comprising a mixed absorbent product consisting of: (a) an acquisition surface facing the skin comprising a film that is capable of being perforated without substantial stretching, said acquisition surface that gives the skin has a side that gives the skin and a side that gives out; (b) an absorbent center associated contiguously with said acquisition surface that gives the skin on its outward facing side, said absorbent center having a side facing the skin and an outward facing side; and (c) a layer of barrier film associated contiguously with said absorbent center on the side facing away from said absorbent center, said layer of barrier film being breathable; said mixed absorbent product has a peak load (5g) according to a Modified Circular Flexing Method of from about 150 to about 250 g; said bandage has the approximate shape of a face and contains openings for eyes, nose and mouth; said bandage further contains grooved lines for creases along its perpendicular axis, equidistant from the midline of the bandage and grooved lines for clips located such that said grooved lines for forceps are at a 45 ° angle from said line medium, starting at the peripheral edge of said bandage.

22. A method for manufacturing a skin bandage for the face comprising the following steps: (a) providing an absorbent layer; (b) cutting a facial mask in said absorbent layer; (c) cutting openings for eyes, nose and mouth in said absorbent layer; (d) sealing the peripheral edges of said mask and said openings using radiant or adhesive energy; (e) making at least two lines grooved about a vertical axis parallel to the midline of said mask, said slotted lines being equidistant from said midline; (f) making at least four lines spaced at 45 ° from said midline, at least one in each quadrant of said mask and (g) folding said mask in said slotted lines to form at least one vertical fold and so minus four clamps.