Abstract:
A protective device having a substantially rigid casing for placement on a patient&#39;s skin, wherein the casing has a hollow interior facing the patient&#39;s skin and a lip. The casing can be spanned across its hollow interior by a membrane. The casing can have a first adhesive seal attached to a bottom surface of the lip of the casing, and a second adhesive seal attached to the top surface of the lip of the casing.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of co-pending U.S. application Ser. No. 13/196,090, filed Aug. 2, 2011, which is a divisional of U.S. application Ser. No. 11/183,165, filed Jul. 14, 2005, now issued as U.S. Pat. No. 7,988,673 on Aug. 2, 2011, each of which is hereby expressly incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This application generally relates to devices for protecting inserted medical devices, wounds, burns, ulcers and the like. More particularly, this application relates to an improved device having one or more adhesive layers and a substantially rigid casing for affixing and covering inserted and applied medical devices, external attachments of inserted and applied medical devices, wounds, burns, ulcers and the like. 
         [0004]    2. Description of the Related Art 
         [0005]    Inserted and applied medical devices are indispensable in modern-day medical practice. Inserted medical devices can include implantable ports, intravascular catheters, percutaneous tubing such as nephrostomy tubes, gastrostomy tubes, or colostomy tubes and the like, indwelling catheters, epidural catheters and external fixator pins. Inserted medical devices can put patients at risk for serious complications due to local and systemic infections, thrombosis and thrombophlebitis. They also can cause pain and discomfort due to inward pressure or compression or snagging of an exit site catheter tail. Applied medical devices such as electrodes that can be used to monitor heart conditions, brain activity or fetal movement, likewise can cause discomfort and are at risk for compression, snagging and inadvertent removal. 
         [0006]    Inserted medical devices such as intravascular catheters can be used to administer long-term or repeated treatments such as chemotherapy, blood transfusions or blood draws, administration of high-calorie liquids and antibiotics while avoiding the need to start an IV each time. Although such devices provide convenient access, their use often negatively impacts patient well-being. Exemplary intravascular catheters include central vascular catheters, peripheral vascular catheters, midline catheters, peripherally inserted central catheters, hemodialysis catheters, pulmonary catheters, umbilical catheters and scalp vein catheters. 
         [0007]    Another inserted medical device is an implantable port. An implantable port sits under the skin and connects to a catheter cannulating a large blood vessel. The port can be felt as a small bump underneath the skin and specialized needles, such as a Huber needle, can be used to access the port to administer treatments directly into the bloodstream. For short term treatments, the needle is withdrawn from the port. For longer treatments, the needle can be left in place connected to the port. 
         [0008]    Regardless of the type of applied or inserted medical device in use, each requires some means of securement to the patient. Film dressing is well known for the purpose of covering medical devices and external attachments. Transparent, semi-permeable polyurethane dressings have become a popular means of dressing insertion sites (see, for example, U.S. Pat. Nos. 4,614,183 and 3,645,835). Transparent dressings help to secure devices, allow for continuous visual inspection of the device, permit patients to bathe and shower without saturating the dressing, and provide some limited protection against infection. However, there is a need for dressings that can prevent compression, constriction and pain associated with the inadvertent manipulation of the medical devices while also providing adequate protection from infection, snagging and dislodgement. 
         [0009]    Improvements in dressings for wounds due to burns, chronic ulcers, donor sites, post-operative wounds, and a variety of other injuries are likewise needed. Trends in modern medical practice have shown that healing of wounds may be significantly improved by clinical intervention using methods and materials that optimize wound conditions to support the physiological processes of the progressive stages of wound healing. Wound dressings are generally classified as passive, interactive or bioactive products. Traditional wound dressings like gauze and tulle dressings are examples of passive products. These dressings are helpful in collecting heavy exudate drainage, but they require frequent changing, cause irritation and have a tendency to stick to the wound during body movement and dressing removal. Interactive dressing products can include polymeric films, hydrocolloid dressings and hydrogels. These types of materials are mostly transparent, permeable to water vapor and oxygen and impermeable to bacteria. These films are recommended for low exuding wounds in that they are typically overwhelmed by the accumulated exudate moisture during the heavy drainage phase of wound healing. Bioactive dressings deliver substances active in wound healing. Bioactive dressings can deliver therapeutic compounds or the dressing itself can be constructed from material having endogenous wound healing properties. 
         [0010]    There is a need for improved dressings for the purposes of protecting inserted and applied medical devices, affixing external attachments as well as protecting wounds on patients with extensive burns, lacerations and skin damage. 
       SUMMARY OF THE INVENTION 
       [0011]    Among the embodiments disclosed herein is a protective device having a substantially rigid casing for placement on a patient&#39;s skin. The casing can be made of a transparent, semi-transparent or translucent material and can be a variety of shapes including, but not limited to, spherical, cuboidal, triangular, pyramidal, cylindrical, conical and dome shaped. The casing has a hollow interior facing the patient&#39;s skin and a lip. A membrane spans the hollow interior of the casing and can be made of a transparent, semi-transparent or translucent material. An adhesive seal can be attached to a bottom surface of the lip of the casing and another adhesive seal attached to the top surface of the lip of the casing. Each of the casing, membrane, first adhesive seal and second adhesive seal of the disclosed protective device can include a notch. The notches can be aligned with one another forming a slot. The membrane and adhesive seals can be impregnated or coated with an antimicrobial, such as β-lactams antibiotics, penicillins, cephalosporins, carbapenems, monobactams, glycopeptides, aminoglycosides, macrolides, tetracyclines, chloramphenicols, clindamycins, vancomycins, streptogramins, oxazolindinones, fluoroquinolones, metronidazoles, sulfonamides, allylamines, non-azole ergosterol biosynthesis inhibitors, antimetabolite antifungals, flucytosine, azole antifungals, fluconazole, glucan synthesis inhibitors, caspofungin, polyene antifungals, amphotericin B, griseofulvin, antiseptic solutions, chloroxylenol, benzalkonium chloride, chlorhexidine, hexachlorophine, sulfadiazine, iodine compounds, mercury compounds, alcohol, hydrogen peroxide, boric acid, volatile oils, methyl salicylate, heavy metals and silver. 
         [0012]    Also disclosed herein is a method of protecting a medical device. The method can include protecting medical devices including, but not limited to, an intravascular catheter, implantable port, needle, tubing, central vascular catheter, peripheral vascular catheter, midline catheter, peripherally inserted central catheter, hemodialysis catheter, pulmonary catheter, umbilical catheter, scalp vein catheter, percutaneous tubing, nephrostomy tube, gastrostomy tube, colostomy tube, tracheostomy tube, indwelling catheter, epidural catheter, external fixator pin and electrode. The method can include the step of positioning over a medical device on a patient&#39;s skin a substantially rigid casing, wherein the casing has a hollow interior facing the patient&#39;s skin, a lip,, an adhesive seal attached to a bottom surface of the lip and a membrane spanning the hollow interior of the casing. The method can also include the step of securing a medical device with the membrane spanning the hollow interior of the casing. The method includes the step of adhering the casing to the patient&#39;s skin. The casing can be adhered to the patient&#39;s skin with an adhesive seal. A second adhesive seal can be attached to a top surface of the lip of the casing to further secure the casing to the patient&#39;s skin. Each of the casing and the membrane can be made of a transparent, semi-transparent or translucent material. Further, the casing can be a variety of shapes including, but not limited to, spherical, cuboidal, triangular, pyramidal, cylindrical, conical and dome shaped. Each of the casing, membrane, first adhesive seal and second adhesive seal can include a notch and the notches can be aligned with one another forming a slot. 
         [0013]    A method is also provided for protecting a wound. The method includes the step of positioning on a patient&#39;s skin a substantially rigid casing, wherein the casing has a hollow interior facing the patient&#39;s skin, a lip, an adhesive seal attached to a bottom surface of the lip and a membrane spanning the hollow interior. The method includes the step of adhering the casing to the patient&#39;s skin. The casing can be adhered to the patient&#39;s skin with an adhesive seal. A second adhesive seal can be attached to a top surface of the lip of the casing to further secure the casing to the patient&#39;s skin. Each of the casing and the membrane can be made of a transparent, semi-transparent or translucent material. Further, the casing can be a variety of shapes including, but not limited to, spherical, cuboidal, triangular, pyramidal, cylindrical, conical and dome shaped. 
         [0014]    Also disclosed herein is a kit that includes a protective device and instructions for applying the protective device to an individual&#39;s skin. The protective device can include a substantially rigid casing, wherein the casing has a hollow interior, a lip, a first adhesive seal attached to a bottom surface of the lip and a membrane spanning the hollow interior. The protective device also can include a second adhesive seal for further securing the casing to an individual&#39;s skin. The protective device also can include a backing on which the casing arid second adhesive seal are removeably attached. Each of the membrane and the casing can be made of a transparent, semi-transparent or translucent material. The casing can be a variety of shapes including, but not limited to, spherical, cuboidal, triangular, pyramidal, cylindrical, conical and dome shaped. Each of the casing, membrane, first adhesive seal and second adhesive seal of the disclosed protective device can include a notch. The notches can be aligned with one another forming a slot. The membrane can be coated or impregnated with an antimicrobial agent. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is an illustration of one embodiment of a protective dressing covering a needle with attached tubing inserted into an implantable port in the chest of a patient; 
           [0016]      FIG. 2  is a side elevation view of the protective dressing of  FIG. 1 ; taken along the line  6 - 6 ; 
           [0017]      FIG. 3  is an exploded view of one embodiment of a protective dressing; 
           [0018]      FIG. 4  is a perspective view of the protective dressing of  FIG. 3 ; 
           [0019]      FIG. 5  is a top plane view of the protective dressing of  FIG. 3 ; 
           [0020]      FIG. 6  is a cross-sectional view of the protective dressing of  FIG. 5  taken along the line  6 - 6 ; 
           [0021]      FIG. 7  is an exploded view of another embodiment of a protective dressing; 
           [0022]      FIG. 8  is a perspective view of the protective dressing of  FIG. 7 ; 
           [0023]      FIG. 9  is an exploded view of another embodiment of a protective dressing; 
           [0024]      FIG. 10  is a perspective view of the protective dressing of  FIG. 9 ; 
           [0025]      FIG. 11  is an illustration of a protective dressing kit. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0026]    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the disclosed device(s) belong. Disclosed are various devices and methods for affixing, covering and protecting inserted and applied medical devices, external attachments of inserted and applied medical devices, wounds, burns, ulcers and the like. 
         [0027]      FIG. 1  shows a protective dressing  10  adhered to the chest of a patient covering an inserted medical device with external attachments (needle N and tubing T). The protective dressing  10  prevents accidental dislodgement and/or removal of an inserted medical device due to external attachments being snagged by clothing, for example, a bra strap worn by a female patient. Although the Figures show an exemplary device as having a dome shape, the device can be shaped differently than what is shown in the figures. For example, the device can also have a spherical, cuboidal, triangular, pyramidal, cylindrical and conical shape. 
         [0028]    As shown in  FIGS. 2 ,  3 ,  4 ,  5  and  6 , the protective dressing  10  can include a substantially rigid casing  11  having a lip  16 , a membrane  14 , an internal seal  15  and external seal  12 . As best illustrated in  FIGS. 3 and 4 , the casing  11  has a hollow interior spanned by a membrane  14 . The membrane  14  attaches to the casing  11  at the lip  16  by, for example, an adhesive material coating the membrane  14  or due to adhesive properties of the membrane  14  itself. The internal seal  15  is shaped similarly as the lip  16  of the casing  11  and is attached to the bottom of the lip  16  of the casing  11  via the outer margin of the membrane  14 , which is attached to the lip  16 . Thus, the internal seal  15  and the lip  16  of the casing  11  sandwich the membrane  14 . As described for the membrane  14 , the internal seal  15  can be attached to the casing  11  by way of an adhesive material coating the internal seal  15 , intrinsic adhesive properties of the internal seal  15  itself or due to an adhesive coating or adhesive properties of the membrane  14 . 
         [0029]    The external seal  12  .surrounds the outer protuberance of the casing  11 . The external seal  12  contacts the top of the lip  16  of the casing  11  (i.e., the side of the lip  16  opposite of the internal seal  15  and the membrane  14 ). The external seal  12  can be attached to the lip  16  due to an adhesive coating on the bottom side of the external seal  12  or other adhesive property of the external seal  12 . The external seal  12 , internal seal  15  and membrane  14  can be made of adhesive material or coated with an adhesive material. The adhesive parts of the protective dressing  10  can be removeably attached to a backing  17 , such as a wax paper backing and the like. 
         [0030]    The hollow interior of the casing  11 , as it relates to a patient, faces the patient&#39;s skin. The outer protuberance of the casing  11  faces away from the patient&#39;s skin. The casing  11  adheres to the patient&#39;s skin via the internal seal  15 , the membrane  14  and the external seal  12 . The membrane  14  adheres to both the patient&#39;s skin and an applied or inserted medical device and external attachments, for example, a needle N and tubing T. The lip  16  of the casing  11  surrounds the site of the applied or inserted medical device. 
         [0031]    The protective dressing  10  can come in a variety of sizes to accommodate different applied or inserted medical devices and external attachments. For example, the protective dressing  10  and, in turn, the casing  11  can be proportionally sized to cover medical devices and attachments used in the art without excessive inward compression of the medical devices or attachments. 
         [0032]    The casing  11  and the protective dressing  10  can come in a variety of shapes to accommodate the medical devices being protected including: spherical, cuboidal, triangular, pyramidal, cylindrical and conical shapes. In one embodiment, the casing  11  can be dome shaped (as shown in the Figures). The casing  11  can be made of a translucent, semi-transparent or transparent material. This allows for a medical practitioner or the patient to visually inspect the site of the protected device for signs of trouble such as Clotting, breakage, signs of infection of the surrounding skin, accidental dislodgement, bleeding or discharge from the wound site. The casing  11  can be made of various rigid materials exhibiting high tensile, high compressive and high shear strength as well as high impact properties. For example, the casing  11  can be made of glycol modified polyethylene terephthalate (PETG) copolyester. PETG is generally known for stiffness, high tensile, high compressive and shear strength, and high impact properties. Tensile strength of the casing  11  can range from 15-150 MPa (ISO527), and more particularly 45-60 MPa. The rigidity of the casing  11  prevents compression of the protected medical device and external attachments. For example, because the lip  16  of the casing  11  surrounds the site of the medical device any inward pressure on the casing  11  is transferred outwardly to the surrounding lip  16  leaving the medical device and external attachments undisturbed. 
         [0033]    The membrane  14  spanning the hollow interior of the casing  11  can be made of films including polymers such as polyurethane or polyethylene. The membrane  14  also can be made of foams, fibrous products, beads, hydrogels, hydrocolloid dressings, alginates and chitosan. In one embodiment, the membrane  14  is made of perforated plastic film absorbent dressing such as Melolin® (Smith and Nephew Medical Ltd; London, England) or Telfa® (Kendall Ltd; Boston, Mass.), or a vapour permeable film such as Opsite® (Smith and Nephew Medical Ltd; London, England), Tegaderm® (3M Health Care Ltd; St. Paul, Minn.) or Bioclusive® (Johnson and Johnson Ltd; New Brunswick, N.J.). In one embodiment, the membrane  14  is impervious to all fluids and gases. In another embodiment the membrane  14  can be made of hydro gel dressings such as Intrasite® Gel (Smith and Nephew Medical Ltd; London, England), Granugel (Convatec Ltd; UK), Sterigel (Seton Healthcare Ltd; UK) or Nu-gel® (Johnson and Johnson Medical Ltd; New Brunswick, N.J.). In another embodiment, the membrane  14  is permeable to water vapor and some fluids, but impermeable to microorganisms or particulate, etc. In another embodiment, the membrane  14  includes one or more lower adhesive layers and one or more upper absorbent layers that draw and contact fluid from the patient&#39;s tissue through the adhesive layers. 
         [0034]    The membrane  14  can be made of an adhesive material or be covered by an adhesive material. The membrane  14  forms a flexible seal and affixes the medical device and connections between the external attachments of the medical device, such as a needle or tubing attached to the needle, preventing their accidental dislodgement or removal. The membrane  14  is at a tension such that it prevents shifting of the applied or inserted medical device and external attachments, but is not so taut that it inwardly compresses the applied or inserted medical device or external attachments, which can cause the patient pain. As a further benefit, the membrane  14  prevents unwanted entry of air into the lines by maintaining connections between parts of the external attachments of the applied or inserted medical device. As described with respect to the casing  11 , the membrane  14  can be translucent, semi-transparent or transparent allowing for visual inspection of the affixed devices, external attachments and underlying skin. 
         [0035]    The protective dressing  10  can include adhesive seals which help to anchor the protective dressing  10  to a patient&#39;s skin. The internal seal  15  communicates with the bottom of the lip  16  of the casing  11  via the outer margin of the membrane  14 , the top edge of which is attached to the bottom of the lip  16 . The external seal  12  surrounds the outer protuberance of the casing  11 . The external seal  12  contacts the lip  16  of the casing  11  on the side of the lip  16  opposite of the internal seal  15  and the membrane  14 . The internal seal  15  can be a foam material with adhesive on each side. The internal seal  15  adheres to the patient&#39;s skin surrounding the site of the applied or inserted medical device and anchors the protective dressing  10 . Further, the internal seal  15  acts to cushion the lip  16  where it contacts the patient&#39;s skin for the benefit of comfort to the wearer. The external seal  12  can be a flexible, thin film material such as a polyethylene adhesive film material. For example, latex-free surgical tape, such as Transpore® (3M; St. Paul, Minn.), can be used. The external seal  12  adheres to the patient&#39;s skin at the outer perimeter of the applied or inserted medical device site further affixing the protective dressing  10  to the patient&#39;s skin. 
         [0036]    The membrane  14  adheres to the skin and affixes the applied or inserted medical device and external attachments. The internal seal  15  likewise adheres to the patient&#39;s skin and helps to anchor the membrane  14 . The external seal  12 , with contribution by the internal seal  15  and the membrane  14 , collectively adheres the protective dressing  10  to the patient&#39;s skin. Each of the membrane  14 , internal seal  15  and external seal  12  can be applied, removed and re-applied to the patient&#39;s skin without irritation or loss of adhesiveness. 
         [0037]    Also shown in  FIGS. 3 and 4 , each of the casing  11 , external seal  12 , membrane  14  and internal seal  15  of the protective dressing  10  can have a notch ( 21 ,  22 ,  24  and  25 , respectively), which when aligned with one another form a slot  13 . The slot  13  can be wide enough to receive devices or external attachments, for example, a tube such as a catheter, and the like. In one embodiment, the slot  13  can have a uniform width allowing devices or external attachments to lie flush with the patient&#39;s skin. 
         [0038]    Depending on the size of the protective dressing  10  and the size of the device to be protected, the width of the slot  13  can vary. In one embodiment, the width of the slot  13  at the lip  16  of the casing  11  can be at least about 0.005 cm, 0.01 cm, 0.02 cm, 0.03 cm, 0.04 cm, 0.05 cm, 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or 5 cm. 
         [0039]    Depending on the size of the protective dressing  10  and the size of the device to be protected, the length of the slot  13  from the outer edge of the lip  16  of the casing  11  also can vary. In one embodiment, the length of the slot  13  from the outer edge of the lip  16  of the casing  11  can be at least about 0.01 cm, 0.02 cm, 0.03 cm, 0.04 cm or 0.05 cm. In another embodiment, the length of the slot  13  from the outer edge of the lip  16  of the casing  11  can be at least about 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm or 10 cm. 
         [0040]    The width of slot  13  can be either uniform or not uniform. For example, the slot  13  can be narrower at the out edge of the lip  16  of the casing  11  than the width of the slot  13  toward the center of the casing  11  (as shown in  FIG. 4 ). This results in the slot  13  having a keyhole shape. The width of the slot  13  at the outer edge of the lip  16  of the casing  11  can be narrow enough to permit a tube T, such as a catheter, to be wedged between the slot in a friction tight manner. Because the width of the slot  13  toward the center of the casing  11  can be a widened terminus, the tube T can rest unrestricted. This allows the applied or inserted medical devices and external attachments, such as a catheter, to be positioned at an angle with respect to a patient&#39;s skin. Alternatively, the applied or inserted medical devices and external attachments can lie flush against the skin and not be wedged up at an angle. 
         [0041]    The protective dressing  10  can be permeable to both water vapor and oxygen, but impermeable to micro-organisms thereby acting as an effective barrier to external contamination. The casing  11  and membrane  14  can have microscopic pores that allow for the exchange of fluids while restricting movement of larger particles, such as microorganisms or particulate. Further, each of the membrane  14 , internal seal  15  and external seal  12  of the protective dressing  10  can be coated or impregnated with an antimicrobial or combination thereof to help reduce the risk of infection at the site of the wound. 
         [0042]    To apply the protective dressing  10  to protect and secure a medical device, such as tubing attached to a needle inserted into an implanted port, the backing  17  is removed from the protective dressing  10  exposing the adhesive parts of the protective dressing  10 . The adhesive parts of the protective dressing  10  can include the external seal  12 , the internal seal  15  and the membrane  14 . The lip  16  of the casing  11  is positioned over the site of the medical device, such as an implanted port, such that it surrounds the medical device. The membrane  14  spanning the hollow interior of the casing  11  is placed over the external attachments of the medical device, such as tubing and attached needle, forming an adherent sheath encapsulating the external attachments of the medical device. 
         [0043]    The internal seal  15  attached to the lip  16  of the casing  11  is pressed down onto the skin surrounding the site of the medical device and is secured by the adhesive properties or adhesive coating of the internal seal  15 . The external attachments of the medical device are now secured and do not move in relation to the patient&#39;s skin or to the protective dressing  10 . The slot  13  can receive the tubing attached to the needle. The external seal  12  is then pressed down onto the skin. The external seal  12  adheres to the patient&#39;s skin at the outer perimeter of the medical device further securing the casing  11  and external attachments of the device in relationship to the patient&#39;s skin. 
         [0044]      FIGS. 7 and 8  show another embodiment of a protective dressing  110  that includes a substantially rigid casing  111 , a membrane  114 , internal seal  115  and external seal  112 . The membrane  114  contacts the patient&#39;s skin and the lip  116  of the casing  111  surrounds the wound site. The substantially rigid casing  111  adheres to the patient&#39;s skin via the internal seal  115  attached to the lip  116  of the casing and the membrane  114  which spans the hollow interior of the casing  111 . The membrane  114  attaches to the casing  111  at the lip  116  by, for example, an adhesive material coating the membrane  114  or due to adhesive properties of the membrane  114  itself. 
         [0045]    The internal seal  115  is shaped similarly as the lip  116  of the casing  111  and is attached to the bottom of the lip  116  of the casing  111  via the outer margin of the membrane  114 , which is attached to the lip  116 . Thus, the internal seal  115  and the lip  116  of the casing  111  sandwich the membrane  114 . As described for the membrane  114 , the internal seal  115  can be attached to the casing  111  by way of an adhesive material coating the internal seal  115 , intrinsic adhesive properties of the internal seal  115  itself or due to an adhesive coating or adhesive properties of the membrane  114 . The external seal  112  contacts the top of the lip  116  of the casing  111  (i.e., the side of the lip opposite of the internal seal  115  and the membrane  114 ). The external seal  112  can be attached to the lip  116  due to an adhesive coating on the bottom side of the external seal  112  or other adhesive property of the external seal  112 . The external seal  112 , internal seal  115  and membrane  114  can be made of adhesive material or coated with an adhesive material. The adhesive parts of the protective dressing  110  can be removeably attached to a backing  117 , such as a wax paper backing and the like. 
         [0046]    The membrane  114  spanning the hollow interior of the casing  111  can be made of a combination of synthetic and biological materials, such as, dermal replacements made of reconstituted collagen and chondroitin sulfate backed by a polymer layer, or collagen seeded with cells to regenerate the skin. Each of the membrane  114 , internal seal  115  and external seal  112  of the protective dressing  110  can be coated or impregnated with an antimicrobial or combination thereof to help reduce the risk of infection at the site of the wound. The membrane  114  also can be made of films including polymers such as polyurethane or polyethylene. The membrane  114  also can be made of foams, fibrous products, beads, hydrogels, hydrocolloid dressings, alginates and chitosan. In one embodiment, the membrane  114  is made of perforated plastic film absorbent dressing such as Melolin® (Smith and Nephew Medical Ltd; London, England) or Telfa® (Kendall Ltd; Boston, Mass.); or a vapour permeable film such as Opsite-® (Smith and Nephew Medical Ltd; London, England), Tegaderm® (3M Health Care Ltd; St. Paul, Minn.), or Bioclusive® (Johnson and Johnson Ltd; New Brunswick, N.J.). In one embodiment, the membrane  114  is impervious to all fluids and gases. In another embodiment, the membrane  114  can be made of hydrogel dressings such as Intrasite® Gel (Smith and Nephew Medical Ltd; London, England), Granugel (Convatec Ltd; UK), Sterigel (Seton Healthcare Ltd; UK) or Nu-gel® (Johnson and Johnson Medical Ltd; New Brunswick, N.J.). In another embodiment, the membrane  114  is permeable to water vapor and some fluids, but impermeable to microorganisms or particulate, etc. In another embodiment, the membrane  114  includes one or more lower adhesive layers and one or more upper absorbent layers that draw and contact fluid from the patient&#39;s tissue through the adhesive layers. 
         [0047]    The protective dressing  110  can be used to prevent irritation and promote wound healing, for example, in the treatment of burns, chronic ulcers and pressure sores, donor sites, post-operative wounds, and a variety of other injuries. In another embodiment, the protective dressing  110  can exclude the membrane  114  such that it covers a wound and comes into contact only with the skin surrounding the wound site, not the wound itself. 
         [0048]    The protective dressing  110  can be permeable to both water vapor and oxygen, but impermeable to micro-organisms thereby acting as an effective barrier to external contamination while producing a moist environment at the surface of the wound. The casing  111  and membrane  114  can have microscopic pores that allow for the exchange of fluids while restricting movement of larger particles, such as microorganisms or particulate. In another embodiment, each of the internal  115  and external  112  seals of the protective dressing  110  can form a fluid-tight seal with a patient&#39;s skin resulting in the collection of exudate during heavy drainage phases of wound healing. The substantially rigid casing  111  of the protective dressing  110  can be used to cover pressure sores. Pressure sores often occur on the underneath side of immobile or bed-ridden patients. The protective dressing  110  can be worn comfortably by these patients even when covering sores on the underneath side and prevent further compression of pressure ulcers. 
         [0049]    In another embodiment (shown in  FIGS. 9 and 10 ), the protective dressing  210  can have perforations that allow for direct access to the protected underlying site. The protective dressing  210  can include a casing  211 , external seal  212 , membrane  214  and internal seal  215  removeably attached to a backing  217 . The casing  211  and/or the membrane  214  can include one or more perforations ( 221  and  224 , respectively) that allow for direct access to the skin and/or medical devices and external attachments. The diameter of perforations  221  and  224  can vary depending, for example, on the size of the protective dressing  210 . The diameter of  221  and  224  can vary also depending on the size of the device penetrating the perforation(s). In one embodiment, the diameter of perforations  221  arid  224  can be at least about 0.005 cm, 0.01 cm, 0.02 cm, 0.03 cm, 0.04 cm, 0.05 cm, 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm or 5 cm. 
         [0050]    Each of the membranes  14 ,  114  or  214 , internal seals  15 ,  115  or  215  and external seals  12 ,  112  or  212  can be impregnated or coated with one or more antimicrobials to help reduce the risk of infection at the site of the wound or medical device. Antimicrobials can include: antibiotics (including, but not limited to β-lactams, penicillins, cephalosporins, carbapenems, monobactams, glycopeptides, aminoglycosides, macrolides, tetracyclines, chloramphenicols, clindamycins, vancomycins, streptogramins, oxazolindinones, fluoroquinolones, metronidazoles and sulfonamides), antifungals (including, but not limited to allylamines, non-azole ergosterol biosynthesis inhibitors, antimetabolites, flucytosine, azoles, fluconazole, glucan synthesis inhibitors, caspofungin, polyenes, amphotericin B, and griseofulvin), antiseptic solutions (including, but not limited to benzalkonium chloride, chlorhexidine, hexachlorophine, sulfadiazine, iodine compounds, mercury compounds, alcohol, chloroxylenol, hydrogen peroxide, boric acid and volatile oils such as methyl salicylate) and heavy metals such as silver. 
         [0051]    As shown in  FIG. 11 , protective dressings  10 ,  110  or  210  can be provided as part of a kit  300 . The kit  300  generally includes a protective dressing  10 ,  110  or  210  in a sealed, sterilized packaging container  310  along with a set of instructions  320  describing how to apply the protective dressing  10 ,  110  or  210  to the patient&#39;s skin at a wound site or site of an applied or inserted medical device. 
         [0052]    While particular embodiments of the present invention have been disclosed, it is to be understood that various different modifications are possible and are contemplated within the true spirit and scope of the appended claims. There is no intention, therefore, of limitations to the exact abstract or disclosure herein presented.