THE SACS™ INSTRUMENT ASSESSING AND CLASSIFYING PERISTOMAL SKIN LESIONS Content Validated1 Welcome to this educational program on assessing and classifying peristomal skin lesions. You will learn how to implement a peristomal skin assessment instrument within your clinical practice that has multinational scientific evidence in support of it’s use. The SACS™ Instrument was named by the Italian study group who initially developed it (Studio Alterazioni Cutanee Stomali), or the study of alterations in peristomal skin. Since validation in Italy, and an extensive study of over 650 patients during a 3-year period, it has been adopted as best practice by the Italian ET Association (AIOSS). In 2008, a group of expert ostomy nurses in the US reviewed the instrument and recommended changes that could make the instrument easily adaptable to US standards of care and documentation. A content validation study of 166 expert ostomy nurses resulted in strong scientific evidence that the instrument is a valid and reliable peristomal skin assessment measurement. (Content Validity Index-CVI=0.94 out of 1) Disclaimer. The information provided herein is intended to assist the clinician in providing patient care based on best practices for ostomy management. The content of this program is not intended as medical advice and does not represent an exhaustive treatment of the subject matter. This program should be used as a guideline and all recommendations must be considered in view of the patient’s medical condition and the latest package insert information. SACS is a trademark of ConvaTec Inc. © 2010 ConvaTec Inc.

PURPOSE & OBJECTIVES PURPOSE: To provide education and training on how to accurately assess and classify a peristomal skin lesion using the SACS™ instrument. OBJECTIVES: After reviewing the training module and passing the scenario test, you will be able to: Assess and classify the peristomal skin condition using the photo-image guide with corresponding lesion definitions (Type of Lesion – L) Identify the location of the lesion on the peristomal plane using the clock-face visual guide (Topographical Location – T) Document a patient’s SACS™ classification with the appropriate L (Type of Lesion) and T (Topographical Location) language The purpose of this program is to provide individualized education and training on how to accurately assess and classify a peristomal skin lesion using the SACS Instrument. After completing this program you will be able to: Assess and classify the peristomal skin condition using the photo-image guide with corresponding lesion definitions (Type of Lesion – L) Identify the location of the lesion on the peristomal plane using the clock-face visual guide (Topographical Location – T) Document a patients SACS classification with the appropriate L (Type of Lesion) and T (Topographical Location) language

PROGRAM OUTLINE This program is broken into three (3) educational modules and a self-test to assess your understanding: Module 1: Overview Module 2: How to Use the SACS™ Instrument Module 3: Clinical Scenarios Module 4: Self Assessment Read text on-screen

MODULE 1 “The peristomal skin should be intact with no evidence of redness, loss of epidermis or sensations such as itchiness, warmth, or pain” In a study done by Hurlefson (British Journal of Nursing, 2006), 202 ostomy patients were evaluated for peristomal skin disorders. Abnormal peristomal skin was observed in 45% of those evaluated. Of interest is that only 38% of those patients with a peristomal skin complication were aware or agreed that there was a complication, and more than 80% of patients with a peristomal skin complication did not seek professional help. It is essential that both patients and health care professionals are aware that the peristomal skin should be intact with no evidence of redness, loss of epidermis or sensations such as itchiness, warmth or pain. Colwell J, Beitz J. Survey of wound ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: A content validation study. J Wound Ostomy Continence Nurs. 2007;34(1):57-69.

WHAT IS A PERISTOMAL SKIN LESION? ANY compromise in the integrity of the skin around the stoma Negative outcome of living with an ostomy1 Wide range of incidence rates: 10.2-40% (review of 7 studies)1 18-55% 2 Lack of consensus concerning stomal and peristomal complications does not allow for comparison of prevalence rates3 Peristomal skin lesions are defined as any compromise in the integrity of the skin around the stoma. According to Salvadalena (2008), a peristomal skin lesion is a negative outcome of living with an ostomy. As described previously, many patients are not aware of this and do not seek assistance of a health care professional. It is difficult to determine an accurate incidence of peristomal skin lesions because literature reports a wide range. Study techniques, data collection and reporting are not consistent. One reference reports an 18-55% range and another a 10.2-40% range. The major reason cited for the inability to report and compare incidence of peristomal skin complication prevalence and incidence rates is a lack of consensus for definitions of complications. 1 Salvadalena G. Incidence of complications of the stoma and peristomal skin among individuals with colostomy, ileostomy, and urostomy: a systematic review. J Wound Ostomy Continence Nurs. 2008;35(6):596-607. 2 Bosio G, Pisani F, Lucibello L, Fonti A, Scrocca A, Morandell C, Anselmi L, Antonini M, Militello G, Mastronicola D, Gasperini S. A proposal for classifying peristomal skin disorders: results of a multicenter observational study. Ostomy Wound Manage. 2007;53(9):38-43. 3 Colwell J, Beitz J. Survey of wound ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: A content validation study.J Wound Ostomy Continence Nurs. 2007;34(1):57-69.

WHERE ARE PERISTOMAL SKIN LESIONS LOCATED? Under the hydrocolloid adhesive of the skin barrier Under the tape collar of the skin barrier Immediately outside the border of the skin barrier Peristomal skin lesions can be located anywhere surrounding the stoma. Most commonly they develop either under the hydrocolloid adhesive of the skin barrier, under the tape collar of the skin barrier and even outside of the border of the skin barrier. The first photo you see here shows compromised peristomal skin in the area of the entire tape collar of the skin barrier. As you can clearly see, the skin in contact with the hydrocolloid barrier is not fully affected. In the second photo, you can see a full thickness skin lesion close to the stoma. And in the third photo, you can see the compromised skin extends beyond the tape collar border.

WHAT IS THE SACS™ INSTRUMENT? An evidence-based instrument developed out of a clinical need A systematic literature review revealed that no universal system existed to objectively classify peristomal lesions according to type and location The SACS™ Instrument was developed to help establish a standard language for the assessment and classification of peristomal lesions A simple, 3-step process easily understood by all health care providers (note: Although the SACS™ Instrument can serve as a guide for all health care providers, it is not intended to replace specialized formal education nor advanced assessment by a Wound Ostomy and Continence Nurse (WOCN) ) Read the text on slide

CLINICAL BENEFITS OF THE SACS™ INSTRUMENT Provides operational definitions for the consistent interpretation of peristomal skin lesions A content validated measurement instrument to classify lesion type and location (CVI=0.94 out of 1)1 An objective classification system to document the incidence of peristomal skin lesions What are the clinical benefits of implementing the SACS Instrument within your practice? First, it would provide consistent definitions for interpretation of peristomal skin lesions that all levels of health care providers can use. You and your staff will be able to communicate observations related to peristomal skin lesions in an objective way, using a common language. A sound evidence base exists for the validity of the content of the SACS Instrument. Implementing scientifically valid clinical instruments can lead to better patient outcomes.

MODULE 2 How to Use The SACS™ Instrument The SACS Instrument is a simple three-step process. First, the lesion is classified according to the severity of skin involvement. Secondly, the location in reference to the peristomal quadrants is determined. Finally, this classification is documented so all caregivers will be able to monitor and track progress of the lesion. As this module progressed, each step will be reviewed in detail.

PERISTOMAL SKIN LESION DEFINITIONS Progressive dependent upon the depth of skin involved When classifying a peristomal skin lesion according to the SACS Instrument, an alpha-numeric classification is assigned. The L designates lesion. Lesions are classified according to their severity, in other words, by the depth of tissue destruction. The numeric classification progresses as the severity of the lesion progresses. An L1 lesion is classified as a hyperemic lesion, or one in which there is peristomal redness with intact skin. There are no blisters or open areas observed. An L2 lesion is classified as an erosive lesion or a partial thickness lesion. This is an open lesion not extending into the subcutaneous tissue. In other words, only superficial tissue loss can be observed.

PERISTOMAL SKIN LESION DEFINITIONS Only difference between L3 & L4 is the presence of necrotic, non-viable tissue L3 and L4 lesions are both classified as full thickness tissue damage. An L3 lesion is an ulcerative open lesion that extends into and below the subcutaneous tissue. An L4 lesion is similar, however the differentiating factor is that necrotic, non-viable tissue is present somewhere in the lesion.

PERISTOMAL SKIN LESION DEFINITIONS LX is proliferative, or a “build-up” rather than a tissue destruction by erosion The final lesion is not classified in an alpha-numeric code like the first four. In cases where there is damaged peristomal skin in the form of proliferation, such as hyperplasia build-up, granuloma or neoplasm formations, the lesion is classified as an LX, rather than an L5.

HOW TO ASSESS A PERISTOMAL LESION USING THE SACS™ INSTRUMENT 12 12 9 9 3 When the SACS Instrument was developed in Italy, the documentation system used to communicate lesion location was designated “T” for topography. Observations were based upon the abdominal quadrants, so therefore, if a lesion was in the patient’s upper right quadrant of the peristomal skin, it was classified as a T I; lesions in the upper left peristomal quadrant was considered a T II and so forth. The use of Roman Numerals to classify the location according to quadrants is used in order to differentiate observation of the location of the lesion from the lesion type. Due to the fact that the standards of observation and documentation in the United States are based upon a clock-face orientation, the instrument was adapted in that fashion. As illustrated above, when observing the stoma, if the peristomal skin lesion is in the patient’s upper left peristomal quadrant, it is a T I (from 12-3 o’clock), if it is in the lower left peristomal quadrant it is a T II (from 3-6 o’clock), if it is in the patient’s lower right peristomal quadrant it is a T III (from 6-9 o’clock) and if it is in the upper right peristomal quadrant it is a T IV (9-12 o’clock). If the peristomal skin is compromised around the entire peristomal area, it is classified as a T V. 6 Stoma quadrants, not anatomical quadrants Clock-face orientation

TOPOGRAPHICAL LOCATION As described earlier, the location of a peristomal lesion is classified as a T, for topography. In the example above, this lesion would be classified as a T4 because it is in the patient’s upper right peristomal plane.

THREE SIMPLE STEPS In summary, classification of a peristomal skin lesion according to the SACS Instrument is a simple three-step process. First, observe the lesion for the severity and level of skin damage. Next, identify the location of the lesion according to the patient’s peristomal quadrants. Finally, document your findings.

Implementation Materials for your Practice Wall Chart 24x36 inches Brochure Post-it Note Tablet Place on Patient Chart includes Ruler Tear Pad Teaching Guide 8 ½ x 11 inches And a Badge To aid you in the implementation of the SACS Instrument within your clinical practice, ConvaTec has several support tools that will be helpful. (flash these on the slide) A detailed brochure is available that includes a laminated tear-off ruler and pocket or badge size guide for your bedside reference. Wall charts for posting in your nurses station can remind your staff of the importance of identifying and classifying peristomal skin lesions. A tear-off pad of teaching sheets for use in staff education as well as post-it tablets of the Instrument for documentations purposes are also available. For more information, contact your ConvaTec representative or call 1-800-422-8811

MODULE 3 The following two examples were designed as practice exercises. An image of a peristomal lesion will appear on the screen and the program will pause. When you have completed observing the lesion and have classified it according to the SACS™ Instrument, the answer will be provided. Now that you have learned how to classify peristomal skin lesions according to the SACS Instrument, we are going to show you a few examples of just how easy it is. A photo of a lesion will appear on your screen. The program will pause for a few moments to allow you to observe the photo and try to classify the lesion. When you are ready to proceed click on next.

IMAGE # 1 In this example, you can see there is diffuse redness or hyperemia in the peristomal area. The skin remains intact and there are no open areas. The correct classification for this lesion would be an L1. The redness surrounds the entire stoma, and is present in all peristomal quadrants, therefore it would be classified as a T V. L1 , T V

IMAGE # 2 In this photo, the most prominent lesion you can observe is in the lower right peristomal quadrant. It is a full thickness lesion with the presence of some non-viable, necrotic tissue. Therefore, the correct classification of this lesion would be an L4, T III. Keep in mind, when looking at a photo such as this, you don’t have the ability to view the actual stoma and peristomal skin as 3-dimensional. The lesion described above appears to extend a bit into the T IV quadrant as well, so if you classified it as an L 4, T III-T IV, you would not be incorrect. Also, in the T II location, 2 smaller full thickness lesions can be seen. These appear to have all viable tissue, therefore these would be classified as L 3, T II lesions. L4 , T III - IV L3 , T II

MODULE 4 SELF ASSESSMENT INSTRUCTIONS: As you view each slide, evaluate the lesion by following the easy three step process outlined on the SACS™ Ruler Assess and classify Identify lesion location Document

LESION # 1 L ___ , T ___ The student will enter the correct L & T classification on the slide. If the answer is correct, a pop-up box will come up saying “Correct”. If incorrect, the pop-up will give the explanation of how the lesion is classified. Correct answer:L3, T I & T II

LESION # 2 L ___ , T ___ The student will enter the correct L & T classification on the slide. If the answer is correct, a pop-up box will come up saying “Correct”. If incorrect, the pop-up will give the explanation of how the lesion is classified. Correct answer: L X, T V

LESION # 3 L ___ , T ___ The student will enter the correct L & T classification on the slide. If the answer is correct, a pop-up box will come up saying “Correct”. If incorrect, the pop-up will give the explanation of how the lesion is classified. Correct answer: L 3, T IV

LESION # 4 L ___ , T ___ The student will enter the correct L & T classification on the slide. If the answer is correct, a pop-up box will come up saying “Correct”. If incorrect, the pop-up will give the explanation of how the lesion is classified. Correct answer: L 3, T I & T IV also, L 1, T V

LESION # 5 L ___ , T ___ The student will enter the correct L & T classification on the slide. If the answer is correct, a pop-up box will come up saying “Correct”. If incorrect, the pop-up will give the explanation of how the lesion is classified. Correct answer: L 2, T V

Summary Well done! You have completed the educational training module on how to accurately assess and classify a peristomal skin lesion using The SACS™ Instrument. Implementing The SACS™ Instrument provides…. Operational definitions for consistent interpretation of peristomal skin lesions A content validated measurement instrument to classify lesion type and location (CVI=0.94 out of 1)1 An objective classification system to document the incidence of peristomal skin lesions

Conclusion Thank you for participating in the SACS™ Instrument educational module. To access the tools needed to implement SACS™ in your practice, please see the instructions below. For Implementation Materials: Print Materials = All materials are available in full color print form. Please contact your ConvaTec Sales Representative for print copies. Don’t know who your representative is? Call the ConvaTec Interaction Center (CIC) at 1-800-422-8811 for the name and contact information of your ConvaTec representative