A novel low-density lipoprotein/fibrinogen apheresis method for chronic limb-threatening ischemia in patients with poor options for revascularization: A multicenter, single-arm clinical trial.

INTRODUCTION: Low-density lipoprotein (LDL) apheresis is a treatment option for patients with unhealed chronic limb-threatening ischemia (CLTI) after revascularization. The newly developed AS-25 is a direct hemoperfusion-type apheresis device that differs from conventional LDL apheresis therapy and is designed to specifically adsorb both LDL-C and fibrinogen. We evaluate the efficacy and safety of AS-25. METHODS: This study included 61 patients whose ulcers failed to heal after revascularization or were ineligible for revascularization. Of these, 50 were undergoing hemodialysis. The primary endpoint was the healing rate of a target lesion of interest (ulcer), using historical data as control. RESULTS: The ulcer healing rate of 45.9% was significantly higher than the historical data. No significant safety concerns were observed. CONCLUSIONS: AS-25 was effective in healing ulcers and preventing major amputation even in CLTI refractory patients on hemodialysis, thus showing potential clinical applicability and high significance. CLINICAL TRIAL REGISTRATION: UMIN study ID UMIN000020336.

Convergent Validity of Three Pressure Injury Risk Assessment Scales: Comparing the PPRA-Home (Pressure Injury Primary Risk Assessment Scale for Home Care) to Two Traditional Scales.

PURPOSE: The Pressure Injury Primary Risk Assessment Scale for Home Care (PPRA-Home) was developed to predict pressure injury risk in geriatric individuals requiring long-term care in home settings. This study aimed to compare the convergent validity of the PPRA-Home to that of the two other standardized pressure injury prevention scales: the Braden and Ohura-Hotta (OH) scales. METHODS: A multicenter, cross-sectional study was conducted with 34 home-based geriatric support service providers located in five Japanese districts. The study included 69 participants (30 had a pressure injury and 39 did not) who were at classified at care levels of 1 through 5 under Japan's long-term care insurance system. Care managers served as assessors for the PPRA-Home, while physicians or certified expert nurses served as assessors for the Braden and OH scales. Convergent validity was investigated by examining correlation coefficients between total scores on the PPRA-Home and the other two scales. Receiver operating curve analysis was used to quantify each scale's accuracy for the two groups: those with and without a pressure injury. RESULTS: The PPRA-Home was found to be negatively correlated with the Braden scale (r=-0.79, p<0.05), and positively correlated with the OH scale (r=0.58, p<0.05). The area under the curve (AUC) for the PPRA-Home, Braden scale, and OH scale were 0.737, 0.814, and 0.794, respectively. A PPRA-Home cutoff score of 4 had a sensitivity of 63.3% and specificity of 81.6%. CONCLUSION: The AUC for the PPRA-Home as scored by care managers was similar to those of the Braden and OH scales as scored by physicians or expert nurses. More research on the PPRA-Home's content and predictive validity is required.

Inter-Rater Reliability of a Pressure Injury Risk Assessment Scale for Home Care: A Multicenter Cross-Sectional Study.

PURPOSE: The aim of the current study was to assess the inter-rater reliability and agreement of the Pressure Injury Primary Risk Assessment Scale for Home Care (PPRA-Home), a risk assessment scale recently developed for Japan-specific social welfare professionals called care managers, to predict pressure injury risk in geriatric individuals who require long-term home care needs. METHODS: A multicenter cross-sectional study was conducted at 30 home-based geriatric support services facilities located at four local districts in Japan. Eligible participants were individuals who needed partial or full assistance for daily living under Japan's long-term care insurance system (care levels 1-5). The degree of agreement and kappa coefficient were calculated for each item and the total score, after which inter-rater reliability was determined. The effect of the participant's care level on reliability was also evaluated as secondary analysis. RESULTS: A total of 96 participants were assessed by 83 care managers (two assessors scored each participant). The degree of agreement and calculated kappa coefficient of the PPRA-Home total score were 59% and 0.72, respectively, with the inter-rater reliability for the total score determined to be "Substantial". Our subgroup analysis showed that the inter-rater reliability differed according to the participant's care level. Accordingly, the kappa coefficient for the total score was lower in subgroup "care level 1-3" than in subgroup "care level 4-5" (0.51 and 0.76, respectively). CONCLUSION: Our result showed that the PPRA-Home has substantial inter-rater reliability for evaluation of risks of pressure injury development at home care. However, some research focusing on intra-later reliability and validity of the PPRA-Home with adequate sample sizes are required to provide categorical conclusions on whether it can be used for the risk assessment scale in actual clinical settings.

Laser speckle flowgraphy can also be used to show dynamic changes in the blood flow of the skin of the foot after surgical revascularization.

OBJECTIVES: Laser speckle flowgraphy is a new method that enables the rapid evaluation of foot blood flow without contact with the skin. We used laser speckle flowgraphy to evaluate foot blood flow in peripheral arterial disease patients before and after surgical revascularization. MATERIALS AND METHODS: A prospective single-center study. Thirty-one patients with 33 limbs that underwent surgical revascularization for peripheral arterial disease were included. Pre- and postoperative foot blood flows were measured on the plantar surface via laser speckle flowgraphy and skin perfusion pressure. The laser speckle flowgraphy device was used to visualize the blood flow distribution of the target skin and processed the pulse wave velocity of synchronized heart beats. The mean blood flow, which was expressed as the area of the pulse wave as the beat strength of skin perfusion on laser speckle flowgraphy converted into a numerical value, was assessed as dynamic changes following surgery. Beat strength of skin perfusion was also investigated in non-peripheral arterial disease controls (23 patients/46 limbs). RESULTS: The suitability of beat strength of skin perfusion in non-peripheral arterial disease controls was achieved; the beat strength of skin perfusion value was significantly higher in every area of interest in non-peripheral arterial disease controls compared to that in peripheral arterial disease limbs at the preoperative stage (105.8 ± 8.2 vs. 26.3 ± 8.2; P < 0.01). Although the pulse wave before surgery was visually flat in peripheral arterial disease patients, the pulse wave was remarkably and immediately improved through surgical revascularization. Beat strength of skin perfusion showed a dynamic change in foot blood flow (26.3 ± 8.2 at preoperation, 98.5 ± 6.7 immediately after surgery, 107.6 ± 5.7 at seven days after surgery, P < 0.01 for each compared to preoperation) that correlated with an improvement in skin perfusion pressure. CONCLUSIONS: Laser speckle flowgraphy is a noninvasive, contact-free modality that is easy to implement, and beat strength of skin perfusion is a useful indicator of foot circulation during the perioperative period. Further analysis with a larger number of cases is necessary to establish appropriate clinical use.

[Effects of nutrition intervention for pressure ulcer patients--healing rate and speed of wound size and nutrition--].

UNLABELLED: The objective of this multicenter open-label randomized study was for evaluating nutrition intervention on pressure ulcer healing. Tube-fed patients with Stages III to IV pressure ulcers were enrolled. Target energy levels to be given were the same value as at the time of enrollment or BEE×1.1 (activity factor)×1.1-1.3 (stress factor) in the control group, and BEE×1.1×1.3-1.5 in the intervention group. Both groups received the feeding formula Racol(®) for 12 weeks, and were prescribed to have pressure relief mattresses, and to unify the repositioning method, treatment drugs, and wound dressing materials. Ulcer sizes (length×width), nutritional state, and adverse events were evaluated. RESULTS OF THE STUDY: Energy levels administered to the control (n=29) and intervention (n=21) groups were 29.1±4.9 (mean±SD) and 37.9±6.5 kcal/kg/day, respectively. Regarding pressure ulcer size, the interaction between the nutrition intervention and the courses during observational weeks was significant (P<0.001). Similarly, significant differences were observed with weight, waist circumference, Cu (P<0.001), suprailiac skinfold thickness (P<0.01), thigh circumference, and prealbumin (P<0.05), but not with the incidence of adverse events (P=0.360). Principal component analysis indicated remarkable decreases in ulcer size and improvement rates of waist circumference and suprailiac skinfold thickness in the intervention group. Covariance structure analysis showed that nutrition intervention has a direct effect on reduction in ulcer size. The results suggested that aggressive nutrient intervention accelerated the pressure ulcer of wound healing process and had a direct effect on reduction in ulcer size.

Cost-effectiveness of nutritional intervention on healing of pressure ulcers.

BACKGROUND & AIMS: Pressure ulcers not only affect quality of life among the elderly, but also bring a large economic burden. There is limited evidence available for the effectiveness of nutritional interventions for treatment of pressure ulcers. In Japan, recently, a 60-patient randomized controlled trial of nutritional intervention on pressure ulcers demonstrated improvement in healing of pressure ulcers, compared with conventional management. To evaluate value for money of nutritional intervention on healing of pressure ulcers, cost-effective analysis was carried out using these trial results. METHODS: The analysis was carried out from a societal perspective. As effectiveness measures, pressure ulcer days (PUDs) and quality-adjusted life years (QALYs) were estimated. Prevalence of pressure ulcers was estimated by the Kaplan-Meier method. Utility score for pressure ulcers is derived from a cross-sectional survey among health professionals related to pressure ulcers. Costs (e.g., nutritional interventions and management of pressure ulcers) were estimated from trial data during observation and follow-up. Stochastic and qualitative sensitivity analyses were performed to examine the robustness of results. RESULTS: For observation (12 weeks) and follow-up (12-week observation plus 4-week follow-up), nutritional intervention reduced PUDs by 9.6 and 16.2 per person, and gained 0.226 × 10(-2) QALYs and 0.382 × 10(-2) QALYs per person, respectively. In addition, costs were reduced by $542 and $881 per person, respectively. This means nutritional intervention is dominant (cost savings and greater effectiveness). The sensitivity analyses showed the robustness of these results. CONCLUSION: Economic evaluation of nutritional intervention on healing pressure ulcers from a small randomized controlled trial showed that this intervention is cost saving with health improvement. Further studies are required to determine whether this is a cost-effective intervention for widespread use.

Clinical efficacy of basic fibroblast growth factor on pressure ulcers: case-control pairing study using a new evaluation method.

A basic fibroblast growth factor (bFGF) case and a control case whose total scores of Pressure Ulcer Healing Process-Ohura (PUHP-Ohura) and risk factors for pressure ulcers, and level of care for pressure ulcers were equivalent were paired. Twenty-three such eligible pairs were enrolled in this study. Both cases in each pair were treated under conditions in which extrinsic factors such as the use of a pressure-relief mattress and the frequency of postural change were equivalent. The efficacy of bFGF was assessed by analyzing the data obtained over time as the scores of PUHP-Ohura for nine observation items using the SAS MIXED procedure. Treatment of pressure ulcers with bFGF accelerated wound healing over time more significantly than the control in six observation items (exudate volume, ulcer depth, granulation formation, wound edge, epithelialization, total score of the PUHP-Ohura). These data suggest that it may be possible to evaluate drugs for the treatment of pressure ulcers using the PUHP-Ohura wound-assessment tool.

Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial).

The objective of this study was to evaluate the effects of nutrition intervention on nutritional states and healing of pressure ulcers by standardizing or unified factors including nursing, care and treatment in a multicenter open randomized trial. Tube-fed patients with Stage III-IV pressure ulcers were selected. The control group (30 patients) received the same nutrition management as before participating in this trial, whereas the intervention group (30 patients) was given calories in the range of Basal Energy Expenditure (BEE) × 1.1 × 1.3 to 1.5. The intervention period was 12 weeks. The efficacy and safety were evaluated based on the nutritional states and the sizes of ulcers (length × width), and on the incidence of adverse events related to the study, respectively. The calories administered to the control and intervention groups were 29.1 ± 4.9 and 37.9 ± 6.5 kcal/kg/day, respectively. Significant interactions between the presence or absence of the intervention and the intervention period were noted for nutritional states (p<0.001 for body weight, p<0.05 for prealbumin). Similarly, the size of ulcers differed significantly between subjects in the intervention group and in the control group (p<0.001). The results suggest that nutrition intervention could directly enhance the healing process in pressure ulcer patients.

Mechanism leading to the development of pressure ulcers based on shear force and pressures during a bed operation: influence of body types, body positions, and knee positions.

Surface pressures and shear forces were measured in order to clarify the mechanism leading to the development of a pressure ulcer at five sites on the body during the operation of a bed (bed) using a device for simultaneously measuring pressure and shear force. Changes of shear force and pressure when three body types adopted different supine positions, with or without raising/bending the knees (raising the knees), were investigated and analyzed. The results are as follows: a slender body type tends to have the highest shear force at the coccygeal bone site and also has a higher surface pressure at the coccygeal and at the lateral sacral bone sites than an obese body type. On the other hand, an obese body type has a higher surface pressure at the other sites than the slender type. Shear forces at the sacrum and coccygeal bone sites can be reduced during a bed operation by raising the knees. Furthermore, shear forces can be reduced during a bed operation in a supine position by matching the body's bending points with those of the bed or by shifting the subjects 10 cm toward the head of the bed. These new findings are clinically useful in the treatment and the prevention of the onset of pressure ulcers.

Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer.

Basic fibroblast growth factor (bFGF) has been shown to promote wound healing. The present trial evaluated the clinical efficacy of bFGF for diabetic ulcer, a type of refractory skin ulcer, and the dose-response relationship. This was designed as a randomized, double-blind, dose-ranging, placebo-controlled trial. A total of 150 patients with non-ischaemic diabetic ulcers measuring 900 mm2 or less were randomized into a placebo group (n = 51), a 0.001% bFGF group (n = 49) and a 0.01% bFGF group (n = 50), and 148 of these patients received treatment for 8 weeks or less. The efficacy evaluation was carried out on 139 patients who met the protocol in this trial. The primary outcome was the percentage of patients showing 75% or greater reductions in the area of ulcer. The area of ulcer decreased by 75% or more in 57.5% (27/47), 72.3% (34/47), and 82.2% (37/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively, and differences were significant between the 0.01% bFGF and placebo groups (p = 0.025). The cure rate was 46.8% (22/47), 57.4% (27/47), and 66.7% (30/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively. The findings obtained in this trial showed wound healing accelerating effects of bFGF on diabetic ulcers.

Dilemmas in measuring and using pressure ulcer prevalence and incidence: an international consensus.

Pressure ulcer prevalence and incidence data are increasingly being used as indicators of quality of care and the efficacy of pressure ulcer prevention protocols. In some health care systems, the occurrence of pressure ulcers is also being linked to reimbursement. The wider use of these epidemiological analyses necessitates that all those involved in pressure ulcer care and prevention have a clear understanding of the definitions and implications of prevalence and incidence rates. In addition, an appreciation of the potential difficulties in conducting prevalence and incidence studies and the possible explanations for differences between studies are important. An international group of experts has worked to produce a consensus document that aims to delineate and discuss the important issues involved, and to provide guidance on approaches to conducting and interpreting pressure ulcer prevalence and incidence studies. The group's main findings are summarised in this paper.

Influence of external forces (pressure and shear force) on superficial layer and subcutis of porcine skin and effects of dressing materials: are dressing materials beneficial for reducing pressure and shear force in tissues?

The purpose of this study was to measure the impact of external shear force and pressure on a superficial layer of skin and subcutaneous layer with an underlying bony prominence, and also to verify how the influence of these external forces can be reduced after dressings are applied. For this purpose, an experimental model was prepared, consisting of porcine skin and a Predia sensor capable of measuring pressure and shear force simultaneously. External force was applied to the skin model using a 1 kg weight consisting of metal beads. As a result, the control of the shear force value in the subcutaneous layer became approximately 35% smaller than the control in the superficial layer. The shear forces present in the subcutaneous layer were significantly reduced to within 31-45% when compared with the control values, depending on the dressing applied. Regarding the maximum pressures in the subcutaneous layer, the pressure measured following movement was 2.4 times higher in the control than the static pressure and they were also 1.3-1.8 times higher than the static pressure in all instances with the dressing tested. All the dressing materials tested proved to be effective in reducing pressure in the subcutaneous layer compared with the control. Film dressings and hydrocolloid dressings were more effective than hydropolymer and hydrocellular dressings. From the above results, we conclude that efforts made to reduce shear force and pressure may be clinically important.

The Japanese pressure ulcer surveillance study: a retrospective cohort study to determine prevalence of pressure ulcers in Japanese hospitals.

UNLABELLED: Aim. To evaluate the governmental regulation system introduced in October 2002 by investigating the prevalence of pressure ulcers (PUs) and to investigate the relationship between the change in prevalence and the structure and system within hospitals. METHODS: This retrospective cohort study used 2582 randomly sampled hospitals in Japan. Questionnaires were mailed to each type of hospital, including university hospitals, acute hospitals, acute and long-term (mixed care) hospitals, long-term care hospitals, and psychiatric hospitals. Prevalence and severity of pressure ulcers over 4 consecutive periods (1 month before the introduction of regulation, immediately after the introduction, 6 months later, and 1 year later) and related factors for the improved prevalence were assessed. RESULTS: The overall prevalence before the regulation was 4.26%, which decreased to 4.18% immediately after regulation, and to 3.95% and 3.64% 6 months and 1 year later, respectively. The overall proportion of Stage III and IV pressure ulcers acquired after admission was 23.9% and 10.9%, respectively, before introduction of regulation, and gradually decreased to 18.8% and 8.1%, respectively, after 1 year. The related factor for improved PU prevalence was sufficient distribution of alternating air mattresses (odds ratio = 2.259, 95% CI; 1.091-4.679, P = 0.028). CONCLUSION: The governmental regulation had a clinically important effect on the decrease in PU prevalence. The regulation focused on the structure of hospitals was confirmed to influence the outcome of hospital care quality.

Incidence and Clinical Symptoms of Hourglass and Sandwich-shaped Tissue Necrosis in Stage IV Pressure Ulcer.

UNLABELLED: Measuring pressure ulcer outcomes for deep tissue injury (DTI) in pressure ulcers has improved the authors' understanding of DTI. The authors' multidisciplinary team has also identified previously unexplored patterns of tissue necrosis. OBJECTIVE: Illustrate these new patterns of tissue necrosis and report their incidence in a hospital setting. METHODS: Progressive tissue deterioration was explored using CT scans and ultrasonography of 326 Stage IV pressure ulcers with deep tissue injuries (DTI) managed by a multidisciplinary wound care team using standardized protocols of care in a Japanese hospital from June 2002 to June 2006. RESULTS: Two new patterns of pressure ulcer necrosis were found and are illustrated. All patients were checked consecutively and treated by the multidisciplinary team every 2 weeks. Among the consecutive sample of 326 patients, 194 (60%) were common DTI with column-shaped necrosis, including 7 with relatively healthy tissue sandwiched between shallow and deep necrosis. The remaining 132 (40%) had hourglass-shaped area of necrosis, including 20 with sandwiched-shaped necrosis. Hourglass shaped necrosis was associated with a combination of shear forces and pressure over a bony prominence. Sandwich-shaped hourglass necrosis often appeared to heal the superficial tissue but was reopened with deep necrosis that liquified and sloughed. CONCLUSION: Understanding the morphology and course of deterioration and healing of these different types of necrosis has helped the team recognize and manage previously unpredictable DTI, improving staff, patient, and family expectations, and reducing misunderstandings about pressure ulcer development.

[Clinical study using activity-based costing to assess cost-effectiveness of a wound management system utilizing modern dressings in comparison with traditional wound care].

In recent years, the concept of cost-effectiveness, including medical delivery and health service fee systems, has become widespread in Japanese health care. In the field of pressure ulcer management, the recent introduction of penalty subtraction in the care fee system emphasizes the need for prevention and cost-effective care of pressure ulcer. Previous cost-effectiveness research on pressure ulcer management tended to focus only on "hardware" costs such as those for pharmaceuticals and medical supplies, while neglecting other cost aspects, particularly those involving the cost of labor. Thus, cost-effectiveness in pressure ulcer care has not yet been fully established. To provide true cost effectiveness data, a comparative prospective study was initiated in patients with stage II and III pressure ulcers. Considering the potential impact of the pressure reduction mattress on clinical outcome, in particular, the same type of pressure reduction mattresses are utilized in all the cases in the study. The cost analysis method used was Activity-Based Costing, which measures material and labor cost aspects on a daily basis. A reduction in the Pressure Sore Status Tool (PSST) score was used to measure clinical effectiveness. Patients were divided into three groups based on the treatment method and on the use of a consistent algorithm of wound care: 1. MC/A group, modern dressings with a treatment algorithm (control cohort). 2. TC/A group, traditional care (ointment and gauze) with a treatment algorithm. 3. TC/NA group, traditional care (ointment and gauze) without a treatment algorithm. The results revealed that MC/A is more cost-effective than both TC/A and TC/NA. This suggests that appropriate utilization of modern dressing materials and a pressure ulcer care algorithm would contribute to reducing health care costs, improved clinical results, and, ultimately, greater cost-effectiveness.