WO2000043046A2

WO2000043046A2 - Wound management system and wound dressing

Info

Publication number: WO2000043046A2
Application number: PCT/US2000/000492
Authority: WO
Inventors: Rhoda Zione
Original assignee: Rhoda Zione
Priority date: 1999-01-21
Filing date: 2000-01-21
Publication date: 2000-07-27
Also published as: AU3207300A; WO2000043046A3

Abstract

A wound management system (Fig. 7, 8, 9, 10) and wound dressings (Fig. 1, 2, 2A, 3, 4, 5, and 6) uses a software program to evaluate wound assessment data and recommend treatment, wound dressing, frequency, cleansing and irrigation protocols for treating wounds. The software program also generates documentation tools directing proper treatments, management and tracking of the healing outcomes of the wound or wounds involved. Pictorial instructions are generated to direct health care professionals in the proper treatment of the wound. A wound assessment tool is provided for which has a color scale that corresponds to the coloring of wounds indicating whether the wound is deoxygenated and further indicating whether the wound is non-infectious, infectious or in need of tissue growth enhancers. The wound dressing has a 'macro' vent aperture(s) cut (Fig. 1, 2, 2A, 3, 4, 5, and 6) therein which enhance the flow of air to the wound site and venting of gasses from the wound site, while retaining protective covering of the wound. Thedressing involved may be foam, sponges, gauze, surgical pads, and adhesive bandage strips.

Description

WOUND MANAGEMENT SYSTEM AND WOUND DRESSING

DESCRIPTION

A system for medical management of wounds that includes computerized protocols for wound assessment, treatment and documentation of wound healing outcomes is provided. The assessment utilizes a wound assessment tool. The treatment suggests a wound dressing containing apertures. The dimensions of the apertures are proportional to the size of the dressings. The apertures may vary from about 0.25 cm to 1.5 cm in length and from about 0.25 cm to 3.0 cm in width. The apertures permit airflow into the wound and venting of gasses from the wound. The wound dressings and the wound assessment tool are aspects of the present invention.

A generalized programmable and programmed digital microcomputer is utilized by the present invention to aid in making diagnoses which are based on a plurality of symptoms and observations which, although groupable, cannot be grouped into a plurality of levels because the same symptoms may exist in a variety of conditions requiring radically different diagnoses and treatments.

^• The use of the modified wound dressing has remarkably improved wound healing and cost containment in comparison to the prior art. In a hospital setting, the proper use of these modified dressing resulted in the reduction of nosocomial infection from a rate of 10 percent to none within two weeks, where 1000 treatments were performed a week. The wound treatment protocol software, and modified wound dressing can radically reduce the cost of caring for wounds. The average cost of treating a stage 1 wound is sixty percent less than the average cost of treating a stage 2 wound. Accordingly, it is a principal object of the invention to provide a user friendly, easily operated system that engages the support of paraprofessional medical personnel for treating wound under professional supervision. The present invention can be used by various support staff for the effective treatment and care of wounds. This invention can be utilized in physicians' offices, hospitals, clinics, nursing homes, military facilities and by home health care givers. The system for treating wounds clarifies wound assessment and treatment interventions so that support personnel can more easily and accurately administer proper treatment. The wound care system can also aid patients in managing their own care when possible. The system also utilizes care provided by individuals not conversant in the primary language of the region to utilize the system fully and appropriately with little difficult by using the pictorial guides provided.

The clinical management of wounds involves information directives that instruct wound cleansing, irrigation, hydration, medication application, treatment and skin care regimens by organizing written instructions in the format of computerized text and pictures. It serves to enhance and promote wound healing by making apertures or cuts in foam, sponge, gauze, surgical absorption pads and adhesive bandage strips to allow increased airflow, and venting to the wound bed while protecting the wound surface. Pressure relief is also provided when the modified wound dressing made of foam pads having apertures are used for deep wound treatment. This invention serves to direct and standardize the treatment protocols thus increasing the acuity and assessment skills of the health care professionals and staff. The informative directives, dressings, and standardized treatment protocols constitute a wound management system.

It is another object of the invention to provide a system, method and wound dressing for treating wounds that will have a remarkably better outcome than conventional treatments. The present invention provides for wound assessment and treatment as well as digital imaging and documentation of wounds. The invention reduces the occurrence of wound complication events, and adheres to the Food and Drug Adrninistration's Clinical

Practice Guidelines. The wound dressings are particularly designed to permit air to reach the wound and to vent gases from the wound which results in increased oxygenation and perfusion of the wound tissue.

It is a further object of the invention to prevent complications which may result in amputations do to inadequate wound care, to prevent the deterioration of partial thickness wounds to full thickness wounds, and to eliminate nosocomial infections. The invention provides better wound management outcomes for the full range of wounds.

Still another object of the invention is to reduce the cost of wound management overall at hospitals, nursing facilities, other health care facilities, and home. The present invention reduces costs in wound care while increasing wound healing outcomes without complications, and reduces incidents of limb amputations. It is an object of the invention to provide improved elements and arrangements thereof for the purposes described which is inexpensive, dependable and fully effective in accomplishing its intended purposes.

These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is an environmental view of a window cut aperture, having a width and length ranging from about 0.25 cm to about 3.0 cm, in a wound dressing as utilized in deep, stage 4 wounds, according to the present invention.

Fig. 2 is a plan view of a window cut in a wound dressing for use as an external bandage according to the present invention.

Fig. 2 A is a plan view of the contrast of size between the window cut or "macro" vent aperture and the "micro" vent aperture of the bandage. Fig. 3 is a plan view of a window cut aperture, or a bumper cut aperture, having a width and length ranging from about 0.25 cm to about 3.0 cm, in a wound dressing according to the present invention.

Fig. 4 is a plan view of a vent cut aperture, ranging from about 0.25 cm to about 3.0 cm in linear length, in the form of an angle, in a wound dressing for use as an external bandage according to the present invention.

Fig. 5 is a plan view of a vent cut aperture, in the form of lines ranging from about 0.25 cm to about 3.0 cm in linear length, in a wound dressing according to the present invention.

Fig. 6 is a perspective view of a bumper cut aperture, having a width and length ranging from about 0.25 cm to about 3.0 cm, according to the present invention.

Fig. 7 is a front view of the wound assessment tool having a tissue perfusion scale according to the present invention.

Fig. 8 is the first part of a flow chart of the software application according to the present invention. Fig. 9 is the second part of the flow chart of the software application according to the present invention.

Fig. 10 is the third part of the flow chart flow chart of the software application according to the present invention. Similar reference characters denote corresponding features consistently throughout the attached drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A system for medical management of wounds that includes computerized protocols for wound assessment, treatment and documentation of wound healing outcomes is provided; the assessment utilizes a wound assessment tool; and the treatment suggests a modified wound dressing containing apertures. The dimensions of the apertures are proportional to the size of the dressings. The apertures may vary from about 0.25 cm to 1.5 cm in length and from about 0.25 cm to 3.0 cm in width. The apertures permit airflow into the wound and venting of gasses from the wound. The wound dressings and the wound assessment tool are aspects of the present invention.

Generically, the modified wound dressing consists of a sheet of conventional wound dressing having a length, a width, a thickness and an edge circumnavigating the sheet of wound dressing.

The length and the width of the sheet of wound dressing is of sufficient dimensions to cover and protect a particular wound. The sheet of wound dressing has at least one aperture cut therein and extending therethrough. These apertures have a width being about 0.25 cm to about 1.25 cm and a length being about 0.25 cm to about 1.25 cm. Each aperture is located at least 0.25 cm from the edge of the sheet of wound dressing.

There are three cutting modifications for dressings and/or bandages as utilized in this invention. These cutting modifications, or apertures, are referred to herein as window, vent, and bumper cuts and are shown in Figs. 1 through 6. A window is defined as a cut which makes a hole in any open geometric shape such as a circle, oval rectangle, square, or triangle in the foam or other dressing. A window provides a "macro" vent aperture(s) ( Fig 2 A - Size greater the 0.25 cm) to the wound dressing. Current wound dressing manufacturing specifications provides "micro" vent apertures (Fig 2 A - size less than the 0.25 cm). A vent is defined as a cutting modification which makes lines or angles in the foam or other dressing. A bumper cut is analogous to a window cut which is made in a thicker dressing; the thicker dressing has a hole therethrough which is in an open geometric shape such as a circle, oval, rectangle, square, or triangle. Window cuts are shown in Figs. 1 and 2. Vents are shown in Figs. 4 and 5. A bumper cut is shown in Fig. 6. Fig. 3 shows a floor plan for either window cuts or bumper cuts. This invention is intended to encompass the dressings with the cuts therein as well as the process or method of making such cuts as discussed herein. These cutting modifications allow for increased air flow to the wound and the venting of gases off of the wound to enhance tissue perfusion. A window a cut which makes a hole in any open geometric shape such as a circle, oval rectangle, square, or triangle in the foam or other dressing provides ventilation of wounds. Since all dressings are either semi-occlusive or occlusive in nature, this cutting modification remarkably increases the airflow to the wound while bandaged. Foam/sponge dressings or bandages, particularly the FERRIS POLY-MEM ® foam/sponge dressings POLY-MEM ® Pink, POLY-WIC ® and Calcium Alginate White, are uniquely designed to absorb and contain exudate. For example, for deep wound therapy, the Calcium Alginate polymer foam dressing is modified by cutting windows therein. It is then placed at the wound base, under a semi-occlusive dressing, for infection and heavy drainage management, as well as, to increase airflow and provide irregular pressure relief spots on the wound bed. The use of this windowed polymer foam in deep wound therapy enhances cleansing, hydrating, drainage absorption, and circulation to prevent and decrease wound complications such as maceration (deterioration). This can be used safely for grossly infected and draining wounds. Other standard wound dressings, such as 2" by 2" gauze, 4" by 4" gauze, KERLEX® gauze, super sponges, adhesive bandage strip, or large absorption surgical pads can be cut in a similar way and used to assure increased airflow and pressure relief. When an external bandage is utilized and a wound has scant to no drainage, a window is made at the edge of the bandage/dressing to allow for complete coverage of the wound bed while still providing increased airflow to the wound and venting gases off the wound.

Fig. 1 shows a window cut dressing 10 for use in a stage 4 wound or other deep internal wound such as stage 3. The window cut dressing 10 has several windows 12 cut therein. The dressing is a polymer foam dressing, with or without calcium alginate, having six windows 12 cut in two parallel rows, as shown. The window cut dressing 10 is placed internally in the wound A. Opened and fluffed gauze 14 is then placed on top of the window cut dressing 10 and a large surgical absorption dressing 16 is placed external to the wound. The proper cleansing and treatment protocol as discussed elsewhere herein is utilized prior to the dressing application to minimize infection, and deterioration of the wound and to maximize healing. A window cut dressing adhesive bandage strip 20, as shown in Fig. 2, has a window 22 cut into the edge of the bandage area 24, indicated in the drawing by dashed lines. This particular embodiment of the wound bandage according to the present invention allows for complete coverage of the wound bed while permitting air to flow to the wound area and venting of gases therefrom. This particular embodiment is desirable when an external bandage is utilized to cover a wound which has scant to no drainage. Window cuts also may be made in gauze bandages.

A window cut dressing adhesive bandage strip 20, as shown in Fig. 2 A, shows the size contrast of a "macro" vent, window 22, to a "micro" vent 26 which are present throughout the bandage area 24.

Fig 3. demonstrates three possible window shapes that may be cut into a window cut dressing 30. A square 32, a triangle 34, and a circle 36 are possible window cuts that can be made in a sponge, foam, or other dressing material 38. Multiple windows may be cut into a single dressing and these windows need not be the same geometric shape. Bumper cuts also may take the same geometric shapes as window cuts. Either a random or regular placement of apertures is possible.

The vent cutting modification is the process of cutting bandages/dressings to make lines or angles, as shown in Figs. 4 and 5. The vent modifications in foam/sponge dressing, particularly in POLY-MEM® Pink, POLY WlC®, and Calcium Alginate dressings, enhance aggressive treatment regimens of managing an infectious, dehydrated, and draining wounds because of their absorbent, cleansing and hydrating properties. Like window cuts, vent cuts also increases airflow to the wound and vent gases from the wound. The vent cuts also allow for an irregular surface of pressure on the wound bed while providing coverage for the wound bed to decrease drainage and promote hydration factors in the care of such wounds. As a modification for an external foam, sponge, or gauze dressing, a vent is made on the dressing edge to allow for a moderate increase in airflow to the wound and venting gases from the wound while completely covering the wound surface. Fig. 4 shows a vent cut 42 which in angular in shape in a vent cut dressing adhesive bandage strip 40. The angular vent cut 42 is made on the edge of the bandage area 44, indicated in the drawing by dashed lines, but not into the adhesive area 46. Fig. 5 shows another embodiment of vent cut dressing 50. The embodiment of Fig. 5 shows lines 52 cut into a sponge or foam dressing material 54.

The bumper cutting modification is analogous to the window cut but is used with compression therapy. Compression therapy utilizes devices such as UNNA®/PROFORTE® boots or ACE®/STETOPRESS® wraps. A bumper cup dressing is a thicker dressing such as a surgical absorption pad or a stack of 4" by 4" gauzes with an aperture cut in the middle. A bumper is used primarily for moderate to large wound surfaces to provide a central point of pressure relief and increase airflow over the deepest part of the wound. Granulation, epithelialization, and increased tissue perfusion are stimulated by the use of bumper cut dressings in compression therapy. The bumper cut dressing can be secured with a secondary dressing followed by a KERLEX ® or stocking net. The compression boot or wrap is then placed external to the bumper cut dressing, the secondary dressing and the kerlex ® or stocking net. Fig. 6 shows a bumper cut dressing 60 made from a thick dressing 64 made typically of a surgical absorption pad or a stack of gauzes. Typically, a single geometric cut 62 is made in the dressing, as shown.

Gauze bandages/dressings that are windowed or vented for increased airflow are used with hydrochlorites, oxidizing agents or other pharmaceuticals which are prohibited for use with polymer foams bandages/dressings such as the Calcium Alginate. These cuts in gauze are for external therapy and may be utilized as secondary dressing external to the primary dressing as discussed further herein. These dressings may be changed on a daily basis. The window cut foam dressings with antimicrobial (Surfactant 65) are used to hydrate, promote tissue growth, epithelialization, to increase airflow, and enhance the venting of gases from the wound surface. They remarkably enhance these optimal conditions for wound management such that they only require changing 1 to 3 times a week after the infection in the wound has been resolved. The decrease in the frequency of wound dressing change contributes greatly to cost reduction and cost management in wound care. The window cut foam dressing with calcium alginate are used for drainage management, infection control and for increased airflow and gas venting from the wound surface. These window cut foam dressings with calcium alginate are used for external therapy and are changed from three to seven times a week. The multiple widow cut foam with calcium alginate is utilized for drainage management, infection control, pressure relief, increased airflow, and internal, deep wound therapy. The bumper cut foam may be used in a similar manner for pressure relief as the multiple widow cut foam with calcium alginate.

The computer generated treatment regimens are based on seven treatment protocols. These protocols include skin care with lotions or creams for stage 1 wounds; absorbing treatment regimens including iodine preparations for drainage/infection management for stages 2 through 4; absorbing treatment regimens for oraiιiage/infection management for persons allergic to iodine for stages 2 through 4; ointments for hydration therapy for stages 1 through 4; ointments for enzymatic debridement for stages 2 through 4; non-pharmaceutical regimens including foam/sponge for hydration and infection management for stages 1 through 4; and non-pharmaceutical calcium alginate foam/sponge for hydration, drainage and infection management for stages 1 through 4. The particular protocol utilized for an individual wound is specified by the physician's order following standard FDA clinical practice guidelines.

The tissue perfusion scale, as shown in Fig. 7, is provided as a chart or generated by the computer program. There are three indicator strips 112, 114, and 116 on the tissue perfusion scale; the first strip 112 indicates the level of oxygenation, the second strip 114 indicates the color of the wound, and the third strip 116 indicates the state of infection present. The second strip 114 which indicates the color of the wound is used by the care giver to identify the severity of the wound by its color. The color of a wound indicates the oxygenation state as well as whether the wound is infectious. The care giver merely compares the second strip 114 to the wound, and based on where the wound color is on the strip, the care giver can determine the oxygenation level and the state of infection by drawing a horizontal line through the color on the second strip 114 and the other two strips, 112 and 116. The colors on the second strip 114 are discussed here. The first color is red 140 which represents a fully oxygenated and noninfectious wound. The colors referenced herein are defined using the "define custom color" selection in MICROSOFT® applications. Red is defined as about: hue 0, sat 255, lum 102, red 204, blue 0, and green 0. Next comes a series of pink colors from dark pink to pale pink: dark pink 138 is defmed as about: hue 234, sat 255, lum 86, red 172, blue 86, and green 0; medium dark pink 136 is defined as about: hue 241, sat 255, lum 179, red 255, blue 153, and green 102; pink 134 is defined as about: hue 0, sat 255, lum 204, red 255, blue 153, and green 153; light pink 132 is defined as about: hue 0, sat 255, lum 230, red 255, blue 204, and green 204; and pale pink 130 is defined as about: hue 0, sat 255, lum 240, red 255, blue 225, and green 225. The pink wounds correspond to mostly oxygenated 154 or half-oxygenated 152 on the first strip 112 and tissue growth 144 to infectious 142 on the third strip 116. In other words, the pink wounds correspond to an increasing state of de-oxygenation 152 and tissue perfusion on the first strip 112 and the need to implement a tissue growth 144 enhancer to an infectious 142 protocol on the third strip. The pink wounds correspond to wounds frequently found in individuals suffering from diabetes and vascular disease.

The yellow 128 color indicates wounds that have such an increased state of de- oxygenation 152 (in the epidermis and dermis tissue layers) on the first strip 112 that the tissue is necrotic and begins to slough away from the healthy or perfusion tissue in the wound bed. This color also corresponds to the infectious state 142 on the third strip 116.

The yellow is defined as about: hue 28, sat 255, lum 206, red 255, blue 157, and green 222. The gray colors, light gray 126 is defined as about: hue 170, sat 0, lum 234, red 234, blue 234, and green 234; medium gray 124 is defined as about: hue 170, sat 0, lum 215, red 215, blue 215, and green 215; and dark gray 122 is defined as about: hue 170, sat 0, lum 179, red 179, blue 179, and green 179, correspond to half-oxygenated 152 or mostly deoxygenated 150 on the first strip 112 and infectious 142 on the third strip 116. The black 120 color wounds represent the worst condition and represents fully deoxygenated 148 on the first strip 112 and infectious 142 on the third strip 116. Black 120 is defined as about: hue 170, sat 0, lum 0, red 0, blue 0, and green 0. The protocol of the third strip 116 corresponds to instruction indicated in the following tables. Each table corresponds to the proper considerations and treatment for wounds falling in the indicated position on the perfusion scale 110.

Also, on the perfusion scale 110 is a list of consideration which should be evaluated for wounds reading in their area on the scale. This list is referred to as signs and symptoms

118, and includes eschar, dehydration, maceration, infection, drainage, necrotic tissue, inflammation, granulation and epithelialization. The more oxygenated, redder and non- infectious a wound the better such wounds have good tissue perfusion. Wounds with poor tissue perfusion are black, deoxygenated, and infectious. Wounds can go from good tissue perfusion to poor tissue perfusion relatively quickly if proper wound management is not undertaken. The tissue perfusion scale 110 provides a ready means to identify the proper care for wounds. The flow chart for the software program for wound management is depicted in

Figs. 8, 9 and 10. Fig. 8 shows the first part of the software program for wound management. The program starts at begin 210. Initially, the program inputs medical data about the patient, indicated by the input health data box 212. The medical data can either be entered manually or electronically from the patient's records. It includes relevant data such as the name of the patient, their age, medical histories, allergies and other information routinely gathered by medical personnel.

Next, the program requests input of wound assessment data 214. The wound assessment data is made from observations by the health care professionals, staff, physicians, and other staff such as the wound therapist. These observations come from the tissue perfusion scale, shown in Fig. 7, the measurement of the wound, and the pathology of the wound. The information includes the dimensions of the wound, height, width and length, the color of the wound, the stage of the wound (1 through 4), the size of the peri- wound, presence of tunneling or other underniining of the wound, the presence of heat, the presence and amount of drainage, the presence of epithelialization, granulation, eschar, inflammation, state of hydration of the patient and wound, erythema, hyperemia, odor, maceration, and necrotic tissue. The information is input following specific requests for each data or following data field requests. The program permits verification 216 of the information put in to make sure it is correct. The verification may be in the form of a series of questions asking if each input was correct or it may be a list.

The computer queries whether a medical wound protocol is suitable 218. If the wound protocol is not suitable, the program ends. This occurs when the patients wound is so severe that an operational procedure is necessary. If the medical wound protocol is suitable, then the next step is the calculation of the desirable protocol from in the input wound assessment data and health data 220. The desirable protocol is presented in the form of an inquiry 222 which provides the opportunity for a decision about protocol efficacy. If the health care professional wishes to review the proffered protocol's efficacy, then they choose yes and are permitted the opportunity to review reference data 224. If the answer is no or once the reference data is verified, the program for wound management proceeds to the select protocol decision 226 depicted in the flow chart on Fig. 9.

The select protocol decisions 226 permits the health care professional to choose to accept the treatment protocol calculated, to reject the protocol calculated or to pick and choose a hybridization of the protocol calculated. If the protocol calculated, the automated protocol 228, is accepted the program outputs 238 the treatment chosen, the dressing that should be utilized, the frequency of dressing changes/treatment, cleansing composition, irrigation methodology, and a stack of forms or documents to aid in carrying out the protocol as calculated. If the protocol calculated is rejected, then the manual selection 230 is made and the health care professional selects the treatment options and the selected forms are output 240. If the hybrid choice is made, then the semi-automated 232 selection occurs and the health care professional selects the treatment, frequency and dressing, and an automated output of cleansing and irrigation 242 calculations is made. The selected forms or documentation is also output.

Next, the user is permitted the opportunity to edit the forms 234, to verify the data 236, and to inquire 246 about the efficacy of the selection with reference data 248. A decision is then made about the necessity of the treatment plan 250. If the decision is no, the program ends. If the treatment is needed, then the selected development of wound management 252 follows and output 256 of the physician's order and pictorial guide for a specific wound occurs. Finally, the program permits follow up treatment 254 which restarts the process at begin 210 maintaining the already inserted data and permitting changes thereto. Thus, an ongoing wound management process is established which facilitates the continued observation and treatment of a patient's wound.

The record documentation generated may include: a physician's order, wound treatment record, wound number log, wound consultation report, wound care addendum to the daily flow sheet, a wound tracking system, a photo progress report, and a tissue perfusion scale with treatment recommendations.

The physician's order is output by the computer and contains the physician's instructions for the particular wound. Certain data is entered automatically by the program. Name (first, middle, and last), medical record number, date, wound location and wound number are all information entered on the form automatically which have been input previously. Other fields are present which require the physician to input data. These fields include enhanced environment to promote wound healing: team management, eliminate pressure, cleanse wound & peri-wound, irrigate wound & peri-wound, treatment protocol, dressing, and frequency of wound care/skin care. There also is provided a space for the signatures and dates signed of the health care professionals involved in the treatment of the patient. These health care professionals include physician, nurse, physical therapist, occupational therapist, dietician and others. The field enhanced environment to promote wound healing: team management has several options for the physician to select from including OT Consultation, PT Evaluation, Dietary Consultation, Services in Place,

PT/Whirlpool and Other. The Other option permits the physician to specify additional procedures designed to promote wound healing in a text field which follows. The field "eliminate pressure" has four options for the physician to choose. These options include "reposition Q 2 hours", "Bed/Mattress Therapy", "Eliminate Pressure to:", and "Other". The options "Bed/Mattress Therapy", "Eliminate Pressure to:", and "Other" provides additional text fields for specification which the physician may add. The field "cleanse wound & peri-wound" has four options which may be selected: antibacterial soap for the peri-wound, wound cleanser, normal saline solution for the wound bed, and other with a text field for specific instructions. The field "irrigate wound & peri-wound" has three options which may be selected: normal saline solution (3 times each treatment), saline solution (3 times each treatment) followed by 5 minutes soak with normal saline solution soaked 4" by 4" to wound bed, and other with a text field for specific instructions.

The field "treatment protocol" has several options to chose from plus additional instructions. The options include non-infectious, infectious, tissue growth enhancer, and times 14 days & re-evaluate. A text space is provided for particular treatment instructions including an option to order wound dressing or pharmaceuticals from the pharmacy. The next field is "dressing" which has the options DSD, semi-occlusive, occlusive and none. Text fields are provided for the insertion of particular instructions after the options (except none). The final field is "frequency of wound care/ skin care" which serves to specify the frequency of treatment. It includes the options of QOD, QD, BID, Q48 HRS, and other plus text field for wound care, and QD and BID for skin care. The physician"s order serves to direct wound management tasks. It coordinates care of all services, and enhances case coordination. The physician"s order facilitates policy compliance. A wound treatment record is output by the computer as well. The wound treatment record serves to direct wound care. It indicates mounds by number. The wound treatment record serves to increase compliance with policy. The computer output fills in the data for allergic reactions, wound location and type, wound number and other identifying information. It also contains spaces to be filled out by health care personnel including the dates the treatment is ordered and when the order expires for each treatment specified. The treatmenf's specified include wound cleansing, irrigation, and treatment for infectious wounds, tissue growth and non-infectious. The hours that the wounds are treated and spaces for initials and dates that the treatment is carried out. Spaces for signatures are also provided. This form is for verifying that the treatment is carried out and by whom.

A wound number log and a wound tracking system are also provided. These documents serve to identify the wounds on a single patient. The number log assigns a particular unique alphanumeric designation for each wound and specifies the location of the wound. The wound tracking system keeps up with the care and treatment provided for each wound so that the physician and other health care professionals will be able to verify that each wound is properly attended to thus preventing omissions in the treatment.

A photographic wound progress report is provided. This document contains diagrammatic representations of the anterior and posterior of a generic human, and of the inner and outer sides of each foot, the left and right. A space is provided on the form to place a photo of the wound manually or to upload a photo digital image of the wound by computerization. This form includes a staging guideline for pressure ulcers as discussed in the prior art, guidelines for drainage and type of wound bed. The guidelines for the drainage includes the color of the drainage which can be blue, black, brown, clear, green, pink, purple, red, white and yellow; the odor which can be none, mild and foul; the type which can be bloody, serous and purulent. The wound bed is for tissue and these are slough, eschar, granulation, and epithelializing and absent or present. These guidelines aid the care giver in recording data which is necessary for determining the proper care of the wound site. Also a space for recording whether a tissue culture has been taken is provided and the date taken. An area for recording the nutritional and hydration status of the patient is provided which contains boxes for marking the status. It includes food intake with boxes for 75 to 100 percent, 50 to 75 percent, and below 50 percent. Fluid intake is also included with boxes for adequate and inadequate. Urine output is recorded as adequate, and inadequate. Skin turgor is also recorded as good, fair and poor. Ideal body weight is provided with boxes for at, above and below ideal body weight. Actual weight is marked as stable, gaining and losing. An area is provided for recording preventive measures and progress. These measures are high protein supplements, multivitamins/zinc, pressure relieving pads/devices (specify type) and turned q 2 hours (side, back, side). This document also contains spaces for the nurse's signature and the physician's signature. Boxes are provided to indicate diabetes, paralysis, incontinence, sepsis, peripheral vascular disease and end stage. Identifying data for the patient are filled in automatically by the computer as on all of the documentation. The wound progress report serves to catalog the data necessary for the wound management program. A wound consultation report is output by the computer. Identifying data is filled in automatically including name, date, and patient number. The wound consultation report contains fields for history, wound location and treatment recommendations which are analogous to the physicians orders. The treatment recommendations include fields enhanced environment to promote wound healing: team management, "eliminate pressure", "cleanse wound & peri-wound", "irrigate wound & peri-wound", "treatment protocol", "dressing", and "frequency of wound care/skin care". These fields contain only the specified orders from the physician's order form. "Skin care" is an added field for instructions. This report serves to help a wound therapist verify the propriety of the treatment regimen, and contains spaces for the therapist's signature and the physician's name or signature if necessary. Whether the information is transcribed as ordered in the physician's orders in also indicated.

A wound care addendum to the daily flow sheet is provided. The same guidelines as specified in the photographic wound progress report is reproduced including the staging guidelines, drainage and wound bed. This sheet includes wound management regimen for several wounds and includes, for each wound documented, the wound number, wound location, length, width and depth, wound photograph (whether taken or not), stage, skin turgor, drainage (color and odor, type and amount), wound bed, peri-wound skin color, swelling (present or absent), heat (present or absent), pain (0 to 10 scale, least to most), eliminate pressure (specify device), cleanse, irrigation, F/B skin care, dressing, and frequency. Identifying information is automatically filled out. This sheet aids in follow up treatment, documents wound progress and tracks healing outcomes.

The computer generated pictorial guides which are designed to make the treatment regime easier to follow so that any health care provider can implement the treatment regime without error. These guides are designed to simplify wound treatment, transcend learning and language barriers, and instruct treatment with pictures. Identifying information pertaining to the patient is printed on the pictorial guide automatically by the computer. The preferred embodiment of the pictorial guide is a single page having diagrammatic views of the anterior and posterior of a generic human. Indicators, such as dots, are placed on the diagrammatic view of the generic human where a wound exists.

The indicator is labeled so that the specific wound is identified. The label corresponds to the wound number discussed herein elsewhere. A short general instruction is given covering the type of dressing to be utilized thus providing the care giver with the identification of the dressings which should be ready to be applied. Following the short general instruction are stepwise instructions indicating how to apply the dressings and in what order. For example, a general instruction may state after cleanse, irrigation, and hydration with normal saline solution for five minutes followed by light pack funnel area sin small wounds: (insert wound numbers), with dry, opened 2" by 2" gauze, followed by POLY-MEM® (White) Calcium Alginate followed by POLY-MEM® (Pink) Roll to cover all wound areas and redden incision line areas. Secure edges with tape. This short instruction would then be followed by specific stepwise instructions. For example, the stepwise instructions may be step one: after cleanse, irrigation, and hydration with normal saline solution for five minutes, lightly pack funnel areas of wound with dry opened 2" by 2" gauze. Step two: Primary Dressing: apply calcium alginate pad to wound bed and three centimeters of peri-wound (skin around wound) to all areas. Step three: Secondary Dressing: Open POLY-MEMD (pink) Roll and cover wound bed and any redden areas of the incision line. Secure POLY-MEM ® dressing, edges only, with tape. Thumbnail diagrams may be included to indicate where the primary dressing is to be applied, how it is to be folded, the pattern of taping the wound and others which might be helpful. Also, the pictorial guide includes instructions for contraindications for the wound regimen such as not to use surgical pads with POLY-MEM® dressing. Instructions pertaining to expiration date of the guide and when to reevaluate the wounds are indicated on the guide. The pictorial guide, combined with the documentation, instruct the caregiver in assessing, treating and day-to-day management of wounds.

Three phases of the treatment regimen are the pre-application phase, the application phase and the post application phase. The pre-application phase involves the fundamental nursing tasks involving removal of the old dressing followed by a glove change; wound cleansing and irrigation/rinse followed by a glove change, sterile gloves when indicated; three to five minute soak with normal saline; peri-wound skin care with skin lotion or cream followed by another glove change, sterile gloves if needed; and application of an enzymatic debridement, hydration or infection/drainage management treatment, when indicated. The application phase involves the application of the dressing following the cutting of apertures into the foam/sponge or gauze/absorption dressing, or the use of pre- manύfactured dressings having apertures already provided therein. Wound dressing with apertures are essential, especially for wounds with poor circulation, in high pressure areas, with maceration, poor granulation, poor tissue perfusion or poor epithelialization. The dressing is placed internally, externally or both on the peri-wound edge and/or on the wound surface as directed.

The post application phase involves securing the dressings with tape, a conformed bandage such as kerlex®, stocking net, or a compression boot or wrap. An adhesive material such as an Op-site® or a duo-derm® pad may be used to secure the dressing as well. This phase is essential to hold the dressing in place.

Examples of wound care procedures are varied. The wound management for treatment of pressure ulcers which are non- infectious with or without necrotic tissue for stage 1 through 4 wounds are discussed below. For stage 1, after evaluation the enhancements, and environment, the wound and peri-wound should always be cleansed with each dressing changed with the solutions as directed by the physician's order. Normal saline solution should be used for irrigation, when indicated, and the area should be patted dry. Cleansing and irrigation regimens should precede all hydration and debridement treatments. Whenever possible, wounds should be left open and exposed to air for as long as tolerably safe. All ointments and pharmaceutical treatments should be applied at the direction of a physician. Dressing changes should be made as directed by the physician and should include PRN (whenever necessary) provisions in the event of dressing soiling by urine or feces. It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.

Claims

I claim: L A modified wound dressing, comprising: a sheet of wound dressing having a length, a width, a thickness and -an edge -about the periphery of the sheet, the length, and the width of the sheet of wound dressing being of sufficient dimensions to cover and protect a wound, the sheet of wound dressing having at least one aperture cut therein and extending therethrough, the aperture having a width and a length; and wherein: the width of the aperture is between about 0.25 cm to about 1.25 cm; the length of the aperture is between about 0.25 cm to about 1.25 cm; and the aperture is located at least 0.25 cm from the edge of the sheet of wound dressing.

2. The modified wound dressing of claim 1 , wherein the aperture has a geometric shape selected from the group consisting of a line, an angle, a circle, a square, a rectangle, an ovaL a triangle and a polyhedron.

3. The modified wound dressing according to claim 1, wherein the aperture is located at the edge of the dressing so as not to cover the wound but to permit venting therefrom.

4. The modified wound dressing of claim 1, wherein the sheet of wound dressing is made of material selected from the group consisting of sponge, foam, gauze, surgical pad, and adhesive bandage strip;

5. The modified wound dressing of claim 1, wherein the thickness of the sheet of wound dressing is from about 0.5 cm to about 2.00 cm.

6. The modified wound dressing of claim 1, wherein: the thickness of the sheet of wound dressing is between about 0.2 cm to about 0.5 cm; the sheet of wound dressing is made of a material selected from the group consisting of sponge, foam, gauze, surgical pad, and adhesive bandage strip; and the aperture has a geometric shape selected from the group consisting of a line, an angle, a circle, a square, a rectangle, an oval, a triangle and a polyhedroa

7. The modified wound dressing according to claim 6, wherein the aperture is located at the edge of the dressing so that the aperture is not coextensive with the perimeter of the wound but to permits venting therefrom.

8. The modified wound dressing of claim 1, wherein: the thickness of the sheet of wound dressing is from about 0.5 cm to about 2.00 cm; the sheet of wound dressing is made of a material selected from the group consisting of sponge, foam, gauze, surgical pad, and adhesive bandage strip; and the aperture has a geometric shape selected from the group consisting of a line, an angle, a circle, a square, a rectangle, an oval, a triangle and a polyhedron.

9. The modified wound dressing according to claim 8, wherein the aperture is located at the edge of the dressing so that the aperture is not coextensive with the perimeter of the wound but to permits venting therefrom.

10. The modified wound dressing according to claim 1, wherein the thickness of the sheet of wound dressing is from about 0.2 cm to about 0.5 cm.

11. A wound assessment tool comprising a color perfusion scale indicator having a plurality of colors thereon which correspond to the coloring apparent in wounds arranged from the least severe wound coloring to the most severe wound coloring.

12. The wound assessment tool according to claim 11, further comprising a treatment protocol indicator having a scale depicting regions associated with infection states ranging from "non-infectious" to "tissue growth" to "infectious", each infection state being associated with a treatment regimen for that particular infection state; and wherein the scale of the treatment protocol is alignable with the color perfusion scale indicator so that:

13. The wound assessment tool according to claim 11, further comprising: a deoxygenation indicator having a scale from a least deoxygenated state to a most deoxygenated state; and wherein the scale of the deoxygenation indicator is alignable with the color perfusion scale indicator in such a way that the least severe wound color is associated with the least deoxygenated state and the most severe wound coloring is associated with the most deoxygenated state.

14. The wound assessment tool according to claim 12, further comprising: a deoxygenation indicator having a scale from a least deoxygenated state to a most deoxygenated state; and wherein the scale of the deoxygenation indicator is alignable with the color perfusion scale indicator in such a way that the least severe wound color is associated with the least deoxygenated state and the most severe wound coloring is associated with the most deoxygenated state.

15. The wound assessment tool according to claim 11, wherein said plurality of colors includes red, dark pink, medium dark pink, pink, light pink, pale pink, yellow, light gray, medium gray, dark gray, and black arranged in a strip from least severe wound coloring to most severe wound coloring.

16. The wound assessment tool according to claim 12, wherein said plurality of colors includes red, dark pink, medium dark pink, pink, light pink, pale pink, yellow, light gray, medium gray, dark gray, and black arranged in a strip from least severe wound coloring to most severe wound coloring.

17. The wound assessment tool according to claim 13, wherein said plurality of colors includes red, dark pink, medium dark pink, pink, light pink, pale pink, yellow, light gray, medium gray, dark gray, and black arranged in a strip from least severe wound coloring to most severe wound coloring.

18. The wound assessment tool according to claim 14, wherein said plurality of colors includes red, dark pink, medium dark pink, pink, light pink, pale pink, yellow, light gray, medium gray, dark gray, and black arranged in a strip from least severe wound coloring to most severe wound coloring.

19. A wound management software program, comprising the steps of: inputting health data; inputting wound assessment data; calculating a plurality of desirable wound treatment protocols from said health data and said wound assessment data; displaying said plurality of calculated wound treatment protocols; displaying reference material related to said plurality of wound treatment protocols; permitting a user to formulate a wound treatment protocol from the group consisting of a protocol formulated in automated fashion, a protocol formulated by manual selection, and a protocol formulated in semi-automated fashion; reviewing and confirming the formulated protocol; generating and outputting documentation for the treatment of specific wound sites; outputting a plurality of pictorial guides for the treatment of specific wound sites; and outputting a wound treatment protocol designed for specific wound sites, wherein the protocol includes instructions for wound dressing, treatment, frequency, cleansing, and irrigatioa