Defining wound bed conformability: a new testing methodology to assess the relative swelling rise of foam dressings.

OBJECTIVE: Using a dressing that expands and conforms to the wound bed upon exudate absorption is one of the best ways to promote wound healing. While many products claim wound bed conformability, no externally replicated or verified test methodology had been developed to quantify a wound dressing's ability to conform to the wound bed. The Relative Swelling Rise (RSR) test methodology was developed to measure the relative swelling rise of foam dressings upon fluid absorption, and offers a quantifiable and easily replicated method to measure wound bed conformability. METHOD: The RSR test method was developed, validated and reliability tested by Coloplast A/S, Denmark. External replication was provided by ALS Odense, Denmark (previously DB Lab). Circular fences provide a fixed diameter to apply and contain the fluid and prevent horizontal spreading in the test set-up. The swelling height is quantified relative to the fence's inner diameter, i.e., the ratio alpha (α), and allows evaluation of a material's ability to conform to the wound bed. RESULTS: Biatain Silicone foam products (n=3, Coloplast A/S, Denmark) were tested, all afforded an average α-ratio from 0.30 to 0.60. The relative standard deviations were between 1-3%, demonstrating the strength of the test. Robustness of the methodology was demonstrated through the internal validation study, the reliability study, and both an internal and external replication study, as well as a systematic literature review and expert review of the construct, content, criterion and generalisability of the method. CONCLUSION: Having a validated, effective and easily replicable testing method to quantify wound bed conformability of foam dressings is an important step towards achieving better healing outcomes.

IWII Wound Infection in Clinical Practice consensus document: 2022 update.

ABSTRACT: Wound infection is a major challenge for clinicians globally, with accurate and timely identification of wound infection being critical to achieving clinical and cost-effective management, and promotion of healing. This paper presents an overview of the development of the International Wound Infection Institute (IWII)'s 2022 Wound Infection in Clinical Practice consensus document. The updated document summarises current evidence and provides multidisciplinary healthcare providers with effective guidance and support on terminology, paradigms related to biofilm, identification of wound infection, wound cleansing, debridement and antimicrobial stewardship. Integral to the update is revision of wound infection management strategies which are incorporated within the IWII's Wound Infection Continuum (IWII-WIC) and management plan. The aim of the 2022 IWII consensus document update was to provide an accessible and useful clinical resource in at least six languages, incorporating the latest evidence and current best practice for wound infection and prevention. Dissemination techniques for the consensus are discussed and highlighted.

The Hemostatic and Wound Healing Effect of Chitosan Following Debridement of Chronic Ulcers.

INTRODUCTION: Chitosan has been proven to be helpful in wound care as a hemostatic agent. The hemostatic effect is due to the positively charged chitosan interacting with negatively charged red blood cell membranes, initiating the agglutination of red blood cells and platelets. This promotes the activation of thrombin, which activates the clotting pathway, leading to thrombus formation. OBJECTIVE: Based on the properties of chitosan as a rapidly acting hemostatic agent, the authors sought to determine if a chitosan gelling fiber wound dressing could control bleeding of freshly debrided wounds. The effect of the chitosan dressing on overall healing and patient and provider satisfaction was also evaluated. MATERIALS AND METHODS: Wounds of any etiology requiring sharp debridement in patients older than 18 years who were capable of consent were eligible. Wounds were sharply debrided by curettage, scalpel, electrosurgery, or a combination of methods. A chitosan dressing was applied to the freshly debrided wound with gentle pressure. The time from application to hemostasis as assessed by non-progression of blood pattern was measured. Other outcome measures also included digital photography, wound surface area, numerical pain scores, and Photographic Wound Assessment Tool (PWAT) scores. Patient and provider satisfaction were measured. RESULTS: Twenty patients with a variety of etiologies and ulcer types were evaluated. After debridement, wound bleeding was rated as mild (n=9), moderate (n=9), or severe (n=2). The mean time to hemostasis was 75 seconds ± 41 SD (range, 28-221 seconds). In 1 week, the mean wound area decreased from 6.9 cm2 ± 7.8 to 6.2 cm2 ± 7.9 and mean PWAT scores decreased from 17.7 ± 4.9 to 11.4 ± 5.0 (lower score indicates wound healing). Pain scores associated with wound debridement were reduced in all but 1 patient evaluated at week 1. Overall, the rating scores from the Patient Reported Acceptance Questionnaire (PRAQ) and Provider Acceptance Questionnaire (PAQ) developed by this research group were high. The mean total PRAQ score was 30.5 ± 3.9 out of 35 (35 being most satisfied). The PAQ score was 15 out of 15 for all but 1 patient (15 being most satisfied). CONCLUSIONS: The chitosan gelling fiber wound dressing was simple to use and rapidly promoted hemostasis in fresh sharply debrided wounds. It was safe and easy to use in an outpatient setting and was highly rated by the patients.

Economic evaluation of compression stockings for the prevention of venous leg ulcer recurrence in Ontario.

OBJECTIVE: Approximately between 1.5 and 3.0 per 1000 people are affected by venous leg ulcers (VLUs). The treatment and management of VLUs is costly and recurrence is a major concern. There is evidence that compression stockings can reduce the rate of re-ulceration compared with no compression. We present the first cost-effective analysis of compression stockings in preventing recurrence of VLUs from the perspective of the Ontario healthcare system. METHOD: A cost-utility analysis with a five-year time horizon was conducted. Use of compression stockings was compared with usual care (no compression stockings). We simulated a hypothetical cohort of 65-year-old patients with healed VLUs, using a state-transition model. Model input parameters were obtained mainly from the published literature. We estimated quality-adjusted life years (QALYs) gained and direct medical costs. We conducted various sensitivity analyses. RESULTS: Compared with usual care, compression stockings were associated with higher costs and increased QALYs. Cost-utility analysis showed that the incremental cost-effectiveness ratio of compression stockings was $23,864 per QALY gained compared with no compression stockings. The most influential drivers of cost-effectiveness were the utility value of healed VLUs, cost of stockings, number of stocking replacements, monthly prevention cost and the risk of VLU recurrence. CONCLUSION: Compared with usual care, compression stockings were cost-effective in preventing VLUs, using a willingness-to-pay threshold of $50,000. These observations were consistent even when uncertainty in model inputs and parameters were considered.

Lymphedema Impact and Prevalence International Study: The Canadian Data.

Background: Chronic edema/lymphedema is defined as edema present for more than 3 months. It is underrecognized and undertreated. The International Lymphedema Framework developed an international study, Lymphedema Impact and Prevalence International (LIMPRINT), to estimate the prevalence and impact of chronic edema in heterogeneous populations. Canada participated in this study. Methods and Results: Participants were recruited from an outpatient chronic wound management clinic. At a study visit, the following tools were administered: The Core Tool, Demographics and Disability assessment (WHODAS 2.0), Quality-of-life assessment (LYMQOL + EQ-5D), Details of swelling, Wound assessment, and Cancer. Data were entered into an international database (Clindex), and country-specific data were analyzed. Sixty-eight subjects were enrolled. Fifty-seven percent were males and 43% females. More than 90% were older than 45 years. Only 7.35% had primary lymphedema. Most had lower extremity edema (65 of 68). Over half (47.06%) were morbidly obese with body mass index of >40. The most common underlying condition was venous disease. Only 8 of 68 had a history of cancer. While 72.06% had a history of cellulitis, only 10.2% had been hospitalized in the past year. 39.71% had an open wound. More than 75% had received multilayer bandaging, compression garments, wound dressings, and extensive counseling. Few had received manual lymphatic drainage, which is not funded. Disability was less than expected. Conclusion: Chronic edema/lymphedema is an underrecognized condition. These data and the wider LIMPRINT study are important tools to advocate for wider recognition and funding of treatment by health care systems.

Phase 3 evaluation of HP802-247 in the treatment of chronic venous leg ulcers.

In 2012 we reported promising results from a phase 2 clinical trial of HP802-247, a novel spray-applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802-247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe. The primary endpoint was the proportion of ulcers with confirmed closure at the end of 12 weeks of treatment. An investigation into the root cause for the failure of HP802-247 to show efficacy in these two phase 3 trials was initiated immediately following the initial review of the North American trial results. Four hundred twenty-one patients were enrolled in the North American (HP802-247, 211; Vehicle 210) and 252 in the European (HP802-247, 131; Vehicle 121) trials. No difference in proportion of closed ulcers at week 12 was observed between treatment groups for either the North American (HP802-247, 61.1%; Vehicle 60.0%; p = 0.5896) or the European (HP802-247, 47.0%; Vehicle 50.0%; p = 0.5348) trials. Thorough investigation found no likelihood that design or execution of the trials contributed to the failure. Variability over time during the trials in the clinical response implicated the quality of the cells comprising HP802-247. Concordance between the two separate, randomized, controlled trials with distinct, nonoverlapping investigative sites and independent monitoring teams renders the possibility of a Type II error vanishingly small and provides strong credibility for the unexpected lack of efficacy observed. The most likely causative factors for the efficacy failure in phase 3 was phenotypic change in the cells (primarily keratinocytes) leading to batch to batch variability due to the age of the cell banks.

Chronic oedema/lymphoedema: under-recognised and under-treated.

Even though it is estimated that at least 300 000 people in Canada may be affected by chronic oedema/lymphoedema, recognition of the seriousness of this chronic disease in health care is scarce. Lymphoedema affects up to 70% of breast and prostate cancer patients, substantially increasing their postoperative medical costs. Adding to this problem are the escalating rates of morbid obesity across North America and the fact that 80% of these individuals are thought to suffer with an element of lymphoedema. The costs related to these patient populations and their consumption of health care resources are alarming. Untreated chronic oedema/lymphoedema is progressive and leads to infection, disfigurement, disability and in some cases even death. Thus, prognosis for the patient is far worse and treatment is more costly when the disease is not identified and treated in the earlier stages. Although the number of individuals coping with chronic oedema/lymphoedema continues to increase, the disparity between diagnosis, treatment and funding across Canada endures. The reasons for this include a lack of public awareness of the condition, insufficient education and knowledge among health care providers regarding aetiology and management and limited financial coverage to support appropriate methods and materials.

Use of the charcot restraint orthotic walker in treatment of neuropathic foot ulcers: a case series.

Although the total contact cast is the criterion standard for the pressure redistribution of challenging foot ulcers, in practice it is not often feasible. The following is a case series that demonstrates an encouraging possibility for the Charcot restraint orthotic walker as a device to be used in more challenging forefoot ulcers.

Special considerations in wound bed preparation 2011: an update©.

This article builds and expands upon the concept of wound bed preparation introduced by Sibbald et al in 2000 as a holistic approach to wound diagnosis and treatment of the cause and patient-centered concerns such as pain management, optimizing the components of local wound care: Debridement, Infection and persistent Inflammation, along with Moisture balance before Edge effect for healable but stalled chronic wounds.

Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury.

OBJECTIVE: To investigate whether electric stimulation therapy (EST) administered as part of a community-based, interdisciplinary wound care program accelerates healing of pressure ulcers in people with spinal cord injury (SCI). DESIGN: Single-blind, parallel-group, randomized, controlled, clinical trial. SETTING: Community-based home care setting, Ontario, Canada. PARTICIPANTS: Adults (N=34; mean age +/- SD, 51+/-14y) with SCI and stage II to IV pressure ulcers. INTERVENTIONS: Subjects were stratified based on wound severity and duration and randomly assigned to receive either a customized, community-based standard wound care (SWC) program that included pressure management or the wound care program plus high-voltage pulsed current applied to the wound bed (EST+SWC). MAIN OUTCOME MEASURES: Wound healing measured by reduction in wound size and improvement in wound appearance at 3 months of treatment with EST+SWC or SWC. RESULTS: The percentage decrease in wound surface area (WSA) at the end of the intervention period was significantly greater in the EST+SWC group (mean +/- SD, 70+/-25%) than in the SWC group (36+/-61%; P=.048). The proportion of stage III, IV, or X pressure ulcers improving by at least 50% WSA was significantly greater in the EST+SWC group than in the SWC group (P=.02). Wound appearance assessed using the photographic wound assessment tool was improved in wounds treated with EST+SWC but not SWC alone. CONCLUSIONS: These results demonstrate that EST can stimulate healing of pressure ulcers of people with SCI. EST can be incorporated successfully into an interdisciplinary wound care program in the community.

Site assessments: early steps on the journey toward outcomes  .

Two volunteers who have continually dedicated time and effort to the Association for the Advancement of Wound Care (AAWC) and the Global Alliance and World Alliance for Wound and Lymphedema Care (WAWLC) describe perceptions of their life-changing overseas volunteer experiences. Learning and teaching became a two-way enrichment process, as volunteers and local healthcare leaders shared knowledge and practice pearls during lectures and hands-on workshops for managing wounds and lymphedema .

Best practice recommendations for the prevention and treatment of venous leg ulcers: update 2006.

PURPOSE: To provide the specialist in skin and wound care with an update in recommended management of venous leg ulcers. TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in wound care and related disorders. OBJECTIVES: After reading this article and taking this test, the reader should be able to:Editor's note: This "Best Practice Recommendations" article is reprinted with permission from Wound Care Canada, The Official Publication of the Canadian Association of Wound Care (2006;4[1]:45-55). It is the third installment of 4 articles originally published in 2006, following the latest Nursing Best Practice Guidelines from the Registered Nurses Association of Ontario (RNAO), which are updated approximately every 3 years. In 2000, the Canadian Association of Wound Care produced and had published its first best practice recommendations for the prevention and treatment of pressure ulcers. In this article, best practice recommendations are discussed for the prevention and treatment of pressure ulcers. The evidence presented is connected to the RNAO's recommendations from its review of the literature up to the writing of its 2006 guidelines. Clinical decision-making in the treatment of pressure ulcers can be guided by the algorithm that directs the clinician to identify and treat the underlying causes, to identify and manage patient-centered concerns, and to provide for good local wound care, considering adjunctive therapies or biologically active dressings when the edge of the wound is not advancing. Finally, the recommendations advise putting into place those organizational and educational activities that support the translations of the guidelines into practice.

Best practice recommendations for the prevention and treatment of pressure ulcers: update 2006.

PURPOSE: The purpose of this article is to enhance the professional nurses' knowledge of the best practice recommendations for the prevention and treatment of pressure ulcers. TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in wound care. OBJECTIVES: After reading this article and taking this test, the reader should be able to: 1. Interpret the pathway to assess and treat pressure ulcers. 2. Differentiate the Registered Nurses' Association of Ontario (RNAO) levels of evidence. 3. Identify the scientific evidence for treatment recommendations.

Effect of ultraviolet light C on bacterial colonization in chronic wounds.

Ultraviolet light C (light wavelength 200 nm to 290 nm) has been shown to kill cultures of antibiotic resistant strains of bacteria such as methicillin-resistant Staphylococcus aureus. To evaluate the ability of ultraviolet light C to reduce the amount and type of bacteria present in chronically infected ulcers, as well as to establish the test-retest reliability of the semi-quantitative swab technique, a prospective, one-group, pre-post treatment study was conducted among patients receiving treatment in several in- and outpatient facilities and nursing homes. Individuals with chronic ulcers exhibiting at least two signs of infection and critically colonized with bacteria (n = 22) received a single 180-second treatment using an ultraviolet light C lamp (wavelength = 254 nm) placed 1 inch from the wound bed. Semi-quantitative swabs taken immediately before and after UVC treatment were used to assess changes in the bacterial bioburden present within the wound bed. Results demonstrated excellent test-retest reliability of the semi-quantitative swab technique used to evaluate the type and amount of bacteria present in chronic wounds (Cohen's kappa = 0.92). Assessment of wound bioburden using semi-quantitative swabs revealed a statistically significant (P <0.0001) reduction in the relative amount of bacteria following a single treatment of ultraviolet light C. The greatest reduction in semi-quantitative swab scores following ultraviolet light C treatment were observed for wounds colonized with the bacteria Pseudomonas aeruginosa and wounds colonized with only one species of bacteria. Significant (P <0.05) reductions in the relative amount of bacteria also were observed in 12 ulcers in which methicillin-resistant Staphylococcus aureus was present. These results confirm previous laboratory studies and demonstrate that ultraviolet light C can kill bacteria such as Pseudomonas aeruginosa, Staphylococcus aureus, and methicillin-resistant Staphylococcus aureus present in superficial layers of chronic wounds.

Treatment of chronic skin ulcers in individuals with anemia of chronic disease using recombinant human erythropoietin (EPO): a review of four cases.

Patients with hemoglobin greater than or equal to 100 g/L may have difficulty healing pressure ulcers because of impaired tissue oxygenation. Decreased hemoglobin is often anemia of chronic disease and may be due to the effects of inflammatory cytokines on erythroid progenitor cells. Recombinant human erythropoietin has been found to reverse anemia of chronic disease and may act as a growth factor in wound healing. To review the effect of 6 weeks of subcutaneous recombinant human erythropoietin 75 IU/kg administered 3 times weekly to resolve refractory anemia of chronic disease and heal Stage IV pressure ulcers, a retrospective chart review was conducted of four spinal cord injured patients (all men, mean age 59 years +/- 19) with Stage IV pressure ulcers and multiple comorbid conditions. The patients received recombinant human erythropoietin either through an inpatient spinal cord rehabilitation unit or an outpatient wound management clinic as part of interdisciplinary care. Mean hemoglobin increased from 88 +/- 7.4 g/L to 110 +/- 3.7 g/L. Mean ulcer surface area decreased from 42.3 cm2 (+/- 40.2) to 37.3 cm2 (+/- 44.3) despite extensive deroofing of one ulcer and subsequent increase in size. Mean ulcer depth decreased from 2.3 cm (+/- 1.2) to 1.2 cm (+/- 1.0). Human recombinant erythropoietin shows promise in resolving the refractory anemia of chronic disease associated with Stage IV pressure ulcers. Further study is suggested.

Development, validity, reliability, and responsiveness of a new leg ulcer measurement tool.

OBJECTIVE: To develop and validate an assessment tool--the Leg Ulcer Measurement Tool (LUMT)--that would be able to detect changes in the appearance of lower extremity ulcers. SUBJECTS: Twenty-two subjects with chronic leg ulcers of various etiologies (arterial, venous, diabetes) participated in the validation study. DESIGN: An interdisciplinary panel consisting of 9 local wound care specialists confirmed content validity. Concurrent criterion validity was determined by correlation of the size domain (1 of 14 clinician-rated domains in the LUMT) with acetate tracing measurement of wound surface area. Reliability was determined using repeated assessments by 4 wound care specialist and 2 inexperienced evaluators; responsiveness was determined using monthly reassessments by a single rater for 4 months. RESULTS: Concurrent criterion validity was r = 0.82. Excellent values of intrarater and interrater reliability (ICC > 0.75) were obtained for total LUMT scores and for many of the 14 individual domains; however, several domains were found to be less reproducible. The LUMT detected change in wound status over time (responsiveness coefficient = 0.84). CONCLUSION: The LUMT can be used by 1 or more assessors, with relatively little previous training, to make reproducible evaluations of lower extremity ulcer appearance and to document change in appearance over time. The LUMT represents a novel assessment tool specifically designed and validated for clinical or research use on chronic leg ulcers.

MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment.

The effective management of nonhealing wounds is based on a complete patient history, a detailed initial assessment of the wound, and an analysis of probable causative factors. This information is used to individualize a management strategy to the underlying pathophysiology preventing healing and to implement appropriate wound interventions. Regular reassessment of progress toward healing and appropriate modification of the intervention are also necessary. Accurate and clinically relevant wound assessment is an important clinical tool, but this process remains a substantial challenge. Wound assessment terminology is nonuniform, many questions surrounding wound assessment remain unanswered, agreement has yet to be reached on the key wound parameters to measure in clinical practice, and the accuracy and reliability of available wound assessment techniques vary. This article, which resulted from a meeting of wound healing experts in June 2003, reviews clinically useful wound measurement approaches, provides an overview of the principles and practice of chronic wound assessment geared to a clinical audience, and introduces a simple mnemonic, MEASURE. MEASURE encapsulates key wound parameters that should be addressed in the assessment and management of chronic wounds: Measure (length, width, depth, and area), Exudate (quantity and quality), Appearance (wound bed, including tissue type and amount), Suffering (pain type and level), Undermining (presence or absence), Reevaluate (monitoring of all parameters regularly), and Edge (condition of edge and surrounding skin). This article also provides some preliminary recommendations targeted to developing best practice guidelines for wound assessment.

Effect of electrical stimulation on chronic leg ulcer size and appearance.

BACKGROUND AND PURPOSE: Electrical current has been recommended for use on chronic pressure ulcers; however, the ability of this modality to improve healing of other types of chronic ulcers is less well established. The purpose of this study was to examine the effect of high-voltage pulsed current (HVPC) on healing of chronic leg ulcers. SUBJECTS: Twenty-seven people with 42 chronic leg ulcers participated in the study. METHODS: The subjects were separated into subgroups according to primary etiology of the wound (diabetes, arterial insufficiency, venous insufficiency) and then randomly assigned to receive either HVPC (100 microseconds, 150 V, 100 Hz) or a sham treatment for 45 minutes, 3 times weekly, for 4 weeks. Wound surface area and wound appearance were assessed during an initial examination, following a 1- to 2-week period during which subjects received only conventional wound therapy, after 4 weeks of sham or HVPC treatment, and at 1 month following treatments. RESULTS: The results indicated that HVPC applied to chronic leg ulcers reduced the wound surface area over the 4-week treatment period to approximately one half the initial wound size (mean decrease=44.3%, SD=8.8%, range=2.8%-100%), which was over 2 times greater than that observed in wounds treated with sham units (mean decrease=16.0%, SD=8.9%, range=-30.3%-83.7%). DISCUSSION AND CONCLUSION: The results of the study indicate that HVPC administered 3 times a week should be considered to accelerate wound closure of chronic leg ulcers.