Leg ulcers are an underestimated problem in primary health care, particularly

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1 ORIGINAL RESEARCH Development and Implementation of a Clinical Pathway To Improve Venous Leg Ulcer Treatment Prof. Anneke E. Andriessen, RN, CNS, MA, PhD; 1 Roberto Polignano, MD; Martin Abel, PharmD 3 WOUNDS 9;1(5): From the 1 Thames Valley University, CRICP, London, United Kingdom; Department of Cardiology and Angiology, Orthopedic Institute of Tuscany, Italy; 3 Lohmann & Rauscher GmbH, Rengsdorf, Germany Address correspondence to: Anneke E. Andriessen, RN, CNS, MA, PhD Andriessen Consultants Zwenkgras 5 Malden 6581 RK Netherlands anneke.a@tiscali.nl Phone: Disclaimer: This study was supported by an educational grant of Lohmann & Rauscher GmbH. Dr. Abel is an employee of Lohman & Rauscher GmbH. Abstract: A clinical pathway (CP) was developed and implemented to improve treatment outcomes for patients with venous leg ulcers. The CP and products (Rosidal sys, Suprasorb A, Suprasorb P, and Suprasorb C, Lohmann & Rauscher GmbH, Rengsdorf, Germany) were tested by case evaluation. Patients from the center were examined to determine his or her general condition, associated factors, wound type and stage, wound evolution, quality of life (QOL), treatment efficacy, and costs. Patients with venous leg ulceration (N = ) were recruited to the clinical evaluation. Examination was performed upon presentation, and then at -week intervals for 1 weeks. The patients were then followed until ulcer closure. The outcome of the study group (SG) was compared to the results of a randomly selected patient control group (CG) at the center before implementing the clinical pathway. Statistic evaluation was performed using StatXact 5., double sided (α =.5) for paired and Wilcoxon test, and unpaired with Mann-Whitney (N =, [1/1]). After implementation, a statistically significant (P <.5) shorter period for ulcer closure was demonstrated for the SG when compared to previous treatment given to the CG. In the SG, 5/1 ulcers closed within 1 weeks versus 3/1 in the CG. An improvement in QOL was noted for the SG (P <.5 for the combined parameters, and P <.5 for pain), as well as cost savings (P <.5). The CP applied throughout the complete care chain improved quality of treatment outcomes and made effective use of resources and materials. Leg ulcers are an underestimated problem in primary health care, particularly among elderly patients. One to % of the population will suffer from a poorly healing ulcer of the lower extremity in their lifetime. 1 Prevalence increases with age (> 8 years) to almost per 1. Ambulatory venous hypertension is the final common pathway, which in most cases leads to venous ulcer (VU) formation. 3 Subsequently, the superficial venous network may be exposed to much higher pressures than normal, up to 9 mmhg instead of the normal 3 mmhg. 4 Increased pressure causes the veins to over dilate. 4 The valves become incompetent leading to reflux, which can lead to venous stasis. Slower flow rates in areas of stasis result in deposits of red blood cells and increased blood viscosity. 4 When valves in the perforator veins become incompetent, reflux also Vol. 1, No. 5 May 9 17

2 Patient presents with a suspected venous leg ulcer. Assessment (A): 1) Clinical history. ) Assessment/measurement. 3) Differential diagnosis. yes OTHER no VENOUS ULCER (B) no yes VENOUS WITH ARTERIAL II Disease specific treatment OUTCOME DEFINITION (D) Refer to vascular specialist; no compression III EXIT no EXIT COMPRESSION (E) 1) Multi-layer (elasticinelastic) ) Reduced compression MEDICAL/SURGICAL TREATMENT (F) Reason for Referral (M) Allergy; Unable to tolerate compression; uncontrolled pain; no reduction in ulcer size in 1 month; ulcer duration > 6 months; cellulitis unresponsive to treatment; frequent recurrence APPROPRIATE DRESSINGS (G) SKIN CARE (H) ADJUNCTIVE THERAPIES EDUCATION (H) Active/mobile patient (I) Immobile/fixed ankle patient (J) 1) Multi-layer compression (1st line therapy) ) Multi-layer compression + IPC (nd line therapy) Ulcer is closed post treatment (K) 1) Prevention of recurrence EXIT Box 8: Clinical pathway used for the study group Ulcer fails to close/no reduction in size after 6 weeks of treatment (L) 1) Refer to specialist ) Re-evaluation including diagnosis and re-assessment 3) Evaluation for surgical corr. or skin grafting (punch grafting) IV Figure 1. The clinical pathway. 18 WOUNDS

3 affects the superficial venous system. Blood flow is reversed and veins become damaged. 4 Venous ulcers are a unique type of wound because the underlying condition usually has developed over several years and is often unknown to the patient. 3 Venous leg ulcers are associated with considerable clinical problems, such as high levels of exudate and disproportionate limb sizes and shapes. 3 It is generally recognized that sustained compression is required to promote leg ulcer closure. 4 9 Graduated compression is used to counteract venous hypertension, which is the main component of managing venous leg ulceration Effects of compression on microcirculatory levels may include: acceleration of blood flow in the capillaries, reduction of capillary filtration, and increased re-absorption due to enhanced tissue pressure and improved local lymphatic drainage. 5 Compression has been demonstrated to reduce edema and improve superficial skin lymphatic function, as well as lymph transport within the sub-fascial system. 4,15 Depending on the parameters measured, higher pressures are suggested to be more effective than lower pressures. 4,15 There is a need for a standardized multidisciplinary approach with emphasis on training, research, prompt assessment of the patient, and quick access to specialists. 3 Time to ulcer closure is the critical factor in cost-effectiveness analysis. 4,5 A commonly used technique 8,11 for applying short stretch bandages is to use bandages 8-cm and 1-cm wide, and to start wrapping at the foot using a modified Sigg technique. The bandages may be washed and reused. Materials and Methods A clinical pathway (CP) was developed, validated, and implemented, to improve cost efficacy of treatment for patients with venous leg ulcers. The CP and selected products were tested by using case evaluation, looking at clinical efficacy, time to ulcer closure, wound evolution, quality of life (QOL), and cost efficacy. For details on the QOL aspects questionnaire see Table 1. The QOL questionnaire was filled out on a weekly basis by the clinician according to the answers given by the patient. Cost efficacy was assessed through looking at time to ulcer closure, materials used during treatment, clinician s time and QOL aspects. Clinical examination was performed, Table 1. Aspects of QOL included in the questionnaire. Aspect of QOL Physical complaints Everyday living Social activities Psychological wellbeing Therapy Satisfaction during treatment General health status Specific aspects regarding the ulcer Overall QOL Details Pain, sleeping disorders, itching, wound exudate, headache, trembling, burning sensation at the wound site. Shopping, physical exercises, in the course of the day my condition worsens, my leisure activities are hindered, etc. Were your activities with others reduced? Did you feel dependent on the assistance of others? Did you withdraw from the company of other people? Feelings of irritation and anger, depression, worry about your wound(s), strength, exhaustion, activity and energy, tiredness, apathy. The treatment is a burden for me; the treatment is time consuming; I require assistance for conducting the treatment; the wound treatment impairs me with performing my tasks in my occupation or in the household; wound treatment impairs my leisure activities; for daily wound care I require a total of minutes. How satisfied were you with your: leisure activities; friends; physical condition; performance; general health; physician who performs your treatment; the condition of your wound(s)? During the past week, how would you rate your general health status? During the past week, how would you rate the progress of your wound, etc.? During the past week, how would you rate QOL overall? Vol. 1, No. 5 May 9 19

4 depending on the wound type, upon the start of the treatment and at -week intervals for a period of 1 weeks. The patients were then followed until ulcer closure. The study group (SG) received treatment with a short stretch compression system and a dressing, depending on wound condition, as defined in the clinical pathway (Figure 1). The patients in the control group (CG) received conventional treatment (compression bandages and a wound dressing) before implementing the clinical pathway. Twenty subjects were included in the study. Data was collected using a questionnaire. Data was entered and verified using a Statistical Package (SPSS). After the questionnaires were completed, each item was analyzed separately and item responses were summed to create a score for a group of items. Responses to a single item on the questionnaire were treated as ordinal data. Notes: The clinician completed the QOL questionnaire once per week according to the patients responses. A 5-point Likert 16 scale was used for rating the various aspects of QOL. This type of psychometric response scale is often used in questionnaires in survey research. At the end of the study, the completed questionnaires were analyzed looking at separate items, as well as summed item responses to create a score for a group of items. Tests were carried out at the 5% significance level; the confidence interval (CI) was 95%. Statistic evaluation was performed using StatXact 5., double sided (α =.5), paired sample with Wilcoxon test, and unpaired with Mann-Whitney (N = [1/1]). The evaluation included structured interviews on how wound management was carried out before implementing the clinical pathway. Available outcomes of the center s treatment of VU patients were used as a baseline. The clinical evaluation observation period was 1 weeks for each patient. The number of patients who withdrew from the study, of which the ulcer had not closed, were listed in full as well as any adverse incidents. Inclusion criteria. 18 years old; men and non-pregnant women; diagnosed with a VU; able to understand the terms of the trial and willing to give consent. Inclusion was considered after any infection had resolved. Exclusion criteria. Significant arterial disease (APBI <.8); other causes: rheumatoid vasculitis; DFU; malignant ulceration; oral and/or topical corticosteroids; participated in this trial previously; ulcer closed or withdrawn; unable to understand the aims and objectives of the trial and/or poor adherence; clinically infected ulcers where frequent dressing changes are required; ulcers < 4 cm² and circumferential ulcers; known allergy to latex or other contents of the trial products. Dressing choice was made at the discretion of the clinician regarding local ulcer management. The following materials were tested in the study: Calcium alginate dressing, available as a wound sheet, for superficial wounds and as wound filler for deep wounds, was used for wounds with high and moderate levels of exudate. Foam (nonadhesive) dressing with absorbent properties was used for moderate to lightly exuding wounds and was also used as a secondary dressing. Collagen dressing with absorbent properties was used for stagnating ulcers and combined with a foam dressing as a secondary dressing. A short-stretch bandaging system was used for compression and consisted of the following: Tubular bandage, nonelastic: the tubular bandage was applied on the skin for protection and dressing fixation. A length of.5 times the size of the lower limb was used one half to cover the dressing, the second half to cover the compression bandage to prevent it from slipping. Foam bandage: the foam bandage is designed to act as padding underneath compression bandages. The padding bandage facilitates even pressure distribution and will not slip since its open pores interlock. It can be washed at a temperature of 4 C 6 C. Short stretch bandage. Fixation bandage. Adhesive, non-elastic fixation tape. Optional: foam rubber pads. The kidney-shaped pad can be applied behind the malleoli to support removal of edema. After the ulcer was cleansed, a dressing was applied and fixed with a fixation bandage. Then the nonelastic tubular bandage was applied. Foam pads were used to provide extra pressure (eg, behind the malleoli) if required. Two foam bandages were used as padding and were applied in a spiral fashion starting at the foot and up the leg to the tibial crest. Finally, two short-stretch bandages were used in a modified Sigg technique the 8-cm bandage was started at the toes and applied up to the calf base. The 1-cm bandage was applied up to the knee in a figure- 13 WOUNDS

eight fashion. The nonelastic tubular bandage was then folded over the leg and secured with a fixation bandage. The bandages were applied and washed on average twice weekly.

Both the bandages and foam padding material can be washed up to 5 times at 9 C, according to the manufacturer s data on file; the kit contains a special washing bag for this purpose.

5 eight fashion. The nonelastic tubular bandage was then folded over the leg and secured with a fixation bandage. The bandages were applied and washed on average twice weekly. These cotton bandages do not have elastic fibers. Both the bandages and foam padding material can be washed up to 5 times at 9 C, according to the manufacturer s data on file; the kit contains a special washing bag for this purpose. For each limb, two sets of bandages (short stretch and foam under-padding bandages) are used for a treatment period of 1 weeks (the duration of the trial.) All of these materials are included in one treatment kit. The analysis plan was as follows: Ulcer areas. Ulcer area (tracing of ulcers margins) on each leg was measured at week, at the time of withdrawal and at weeks, 4, 8, and 1 if the ulcer was not closed. Ulcer closure rate at 1 weeks was 5% (estimate). Stage of the wound. DWCS color classification was used to assess local wound condition. The percentage of color present was monitored and indicated on the ulcer tracings and digital photographs at weeks,, 4, 8, and 1. Patient comfort assessment. In addition to ulcer closure, assessments are made on patients comfort and the level of pain that each patient experiences, at weeks,, 4, 8, and 1 and also the week the ulcer was closed or the patient withdrew from the study. A specifically designed QOL questionnaire was used to assess patients QOL aspects (Table 1). Handling properties of the dressing/bandaging regime. Handling properties of the dressing were recorded at application and after removal of the dressing focusing on ease of use; ease of removal; patient comfort; pain on removal; durability of the regime; and incidence of leakage. Handling properties of the bandage system was recorded at the application and before the removal. Following application of the bandages: ease of application; appearance of the bandages after application. Assessment before removing the bandages: Perfectly in place; partly slipping, bandages still functional; extensive slipping, bandages not functional. Results The ulcer area for the SG showed a faster and larger decrease when compared to the CG. The difference was significant (P <.5, Figure ) improvement -6. Difference in Area of Wound P <.5 Figure. Evolution in wound area, comparison between SG and CG. very good very bad Average rating Difference between SG 5.9 SG beginning P <. Health Scale P <.5 Figure 3. Evolution of health scale situation at the of the study. improvement Difference in Quality of Wound P < Figure 4. Evolution of wound bed condition difference between SG and CG. Difference in Quality of Life improvement P < Difference between SG.3 Difference between SG Difference between CG Figure 5. Improvement of QOL during the study period when comparing SG and CG SG beginning CG beginning CG beginning Difference between CG.9 Difference between CG Vol. 1, No. 5 May 9 131

never 4 P <. Pain Figure 6. Evolution of pain during the study period. Health Rates and Costs Figure 7. Healing rates versus cost reduction.

5 SG beginning SG beginning CG beginning CG beginning More negative = better cost/effectiveness and better perimeter reduction -.5-1 -1.5 - -.5-3 SG P <.5 Reduction Cost Figure 7A.

8 -.9 Ratio = Reduction (1 weeks) Cost Ratio = The number of wound dressings used per patient during the study period for the SG (treated with CP system) was 14 (mean) dressings (range 9 5).

6 never 4 P <. Pain Figure 6. Evolution of pain during the study period. Health Rates and Costs Figure 7. Healing rates versus cost reduction. Perimeter reduction (mm) (1 weeks) rare 3 often always 1 Perimeter reduction (mm). 3.9 Reduction in Ulcer Size Costs P <.5 SG beginning SG beginning CG beginning CG beginning More negative = better cost/effectiveness and better perimeter reduction SG P <.5 Reduction Cost Figure 7A. Reduction in ulcer size versus costs (1 weeks)..1 CG More negative = better cost/effectiveness and better healing rate SG P <.5 CG Ratio = Reduction (1 weeks) Cost Ratio = The number of wound dressings used per patient during the study period for the SG (treated with CP system) was 14 (mean) dressings (range 9 5). For the CG, the number of dressings used per patient was 3 (mean) (range 13 37). The difference between the two groups was significant; P <. (difference of the mean). The evolution in health scale during the study is shown in Figure 3. There was a significant difference between the start of the study and the end of the study regarding the health score for both the SG and the CG. The difference in the SG was larger; however, between the SG and the CG, the difference was not significant. The DWCS color concept model was used to track the evolution of wound bed condition. The model uses three colors: red = granulation, yellow = sloughy tissue, and black = necrotic tissue. Ulcer tracings and digital photographs were used to indicate changes in the ulcers during the study. The evolution of wound bed condition was better and faster for the SG treated with the CP products (P <.5, Figure 4). Quality of life evolution during the study was measured using a specifically designed questionnaire (Table 1). An improvement in QOL was noted for the SG (P <.5) for the combined QOL parameters, as well as for a decrease of pain (P <.5, Figure 5). Pain evolution during the study period was performed using a specific questionnaire, looking at pain patterns, medication, sleeping patterns, etc. There was a significant decrease in pain during the study period for both groups. The reduction in pain was faster and larger for the study group (Figure 6). Treatment costs per patient for 1 weeks treatment for the study group was 8.87 ($37.64) versus 63. ($835.88) for the control group. The total cost per healed patient within the 1-week study period was for the SG 6.4 ($348.14) versus 4.4 ($531.3) for the CG. Healing rates and cost reduction are shown in Figure 7. The difference between SG and CG was significant (P <.5). Figure 7A shows the reduction in ulcer size versus costs between the two groups. The compression system for the CP group was reported as simple to apply. As these are short-stretch bandages, the clinicians readily understood how to apply them at full extension. The clinicians noted that the use of foam bandages under the padding helped the bandages stay in place for the intended period and prevented the bandages from slipping. 13 WOUNDS

7 Discussion In leg ulcer treatment, there is still little evaluation of treatments used and patient outcomes. A UK-based project applied a rationalization of community service linked to acute services. The approach of standardized treatment protocols and education improved a liaison between professionals in community leg ulcer clinics. 17 It was suggested that the education should not only promote the use of research-based practice, but is to be developed and evaluated through research. Although the number of patients included in the present study was limited, the study looked at various relevant aspects of the treatment of patients with leg ulcers and confirmed results shown in the literature. 7,11,17 The present study demonstrated an improvement in QOL aspects as well as quality of care. Cost savings are not just due to the application of more effective materials. 17 Treatment outcomes are influenced by the knowledge and motivation of both patients and clinicians. Moreover, an improved level of knowledge and communication between the clinicians involved in the care of patients with venous leg ulcers was instrumental in the demonstrated outcomes. Conclusion Communal knowledge and effort can be tuned to the interest of patients and institutions. Clinical pathways applied throughout the continuum of care support overall improvement in the quality of care. The CP system used in the SG was shown to be significantly superior regarding evolution of the wound bed and QOL aspects when compared to the CG. The CP system demonstrated a trend toward superior performance regarding wound area reduction health scale, and pain when compared to the CG. References 1. Fletcher A. The epidemiology of leg ulcers. In: Cullum NB, Roe BH, eds. Leg Ulcers, Nursing Management: A Research- based Guide. Middlesex, UK: Scutari Press; Geerts WH, Pineo GF, Heit JA, et al. Consensus Conference dell'accp. Chest. 4;16:338S 4S. 3. Andriessen A. The four-layer compression method. In: Gardon-Mollard C, Ramelet AA, eds. Compression Therapy. Masson: Paris, France; 1999: Partsch H. Improvement of venous pumping function in chronic venous insufficiency by compression depending on pressure and material. Vasa. 1984;13: Margolis DJ, Berlin JA, Strom BL. Which venous leg ulcers will heal with limb compression bandages? Am J Med. ;19(1): Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcer. Cochrane Review. Oxford: The Cochrane Library; Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999;3(3): Partsch H, Menzinger G, Mostbeck A. Inelastic leg compression is more effective to reduce deep venous refluxes than elastic bandages. Dermatol Surg. 1999;5(9): Clark M, Compression bandages: principles and definitions. EWMA Position document. Understanding compression therapy. MEP. 3; Duby T, Hoffman D, Cameron J, Doblhoff-Brown D, Cherry G, Ryan T. A randomized trial in the treatment of venous leg ulcers comparing short stretch bandages, four-layer bandage system and a long stretch-paste bandage system. WOUNDS. 1993;5: Partsch H, Damstra RJ, Tazelaar DJ et al. Multicentre, randomized controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers. Vasa. 1;3(): Ukat A, König M, Vanscheidt W, Münter KC. Short-stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates. J Wound Care. 3;1(4): Partsch H, Menzinger G, Borst-Krafek B, Groiss E. Does thigh compression improve venous in chronic venous insufficiency? J Vasc Surg. ;36(5): Moffatt CJ, McCullagh L, O Connor T, et al. Randomized trial of four-layer and two-layer bandage systems in the management of chronic venous ulceration. Wound Repair Regen. 3;11(3): Partsch H. Effekte der Kompressionsthera-pie im Bereich der Beinvenen in Abhängigkeit von Andruck und Materialeigenschaften Eur J Vasc Endovasc Surg. 5;3; Latham GP. Work Motivation: History, Theory, Research, and Practice. SAGE Publications Ltd; Moffatt CJ, Franks PJ, Oldroyd M, et al. Community clinics for leg ulcers and impact on healing. BMJ. 199;35(6866): Vol. 1, No. 5 May 9 133

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