Skin property can predict the development of skin tears among elderly patients: a prospective cohort study

The aim of this study was to identify skin properties that may be used to predict the development of a skin tear (ST) among elderly patients. A prospective cohort study was conducted among elderly patients aged 65 and older (N = 149) at a long‐term medical facility in Japan over an 8‐month period. Skin properties at baseline were measured on the forearm using a 20‐MHz ultrasound scanner, which measured the thickness of the dermis layer and low‐echogenic pixels, and skin blotting method, which evaluated the levels of collagen type IV, matrix metalloproteinase‐2 and tumour necrosis factor‐alpha. Adjusted hazard ratios (HRs) for the main confounders were obtained using the Cox proportional hazard model. A total of 52 STs were recorded among the 21 patients, resulting in an incidence rate of 1·13/1000 person‐days. The predictor of STs was dermis thickness (HR = 0·52; 95% confidence interval = 0·33–0·81; P‐value = 0·004). The cut‐off point for dermis thickness was 0·80 mm (area under the curve = 0·77; 95% confidence interval = 0·66–0·88; P‐value = 0·006). Our results suggest that measuring the dermis thickness at baseline is an easy and accurate way to identify a high‐risk patient.     

Bilirubin provides perforator flap protection from ischaemia‐reperfusion injury in a rat model: a preliminary result

The use of bilirubin, a well‐known and powerful antioxidant, has gained popularity in recent years because of its role in the prevention of ischaemic heart disease in patients with Gilbert's syndrome. We investigate the effects of bilirubin on ischaemia‐reperfusion (I/R) injury using a rat perforator flap model. Forty‐eight rats were randomly divided into two groups: experimental (bilirubin) group (n = 24) and control group (n = 24). In each group, elevated bilateral deep inferior epigastric perforator (DIEP) flaps were created. The right (no ischaemia side) and left (ischaemia side) DIEP flaps were separated according to the presence of ischaemia induction. Ischaemia was induced in anaesthetised rats by perforator clamping for 15 or 30 minutes. After surgery, the flap survival was assessed daily on postoperative days 0 to 5, and overall histological changes of DIEP flaps above the perforator were analysed at postoperative day 5. The flap survival rate in the bilirubin group was significantly higher than that in the control group at the ischaemia side following perforator clamping for 15 or 30 minutes (93·42 ± 4·48% versus 89·63 ± 3·98%, P = 0·002; and 83·96 ± 4·23% versus 36·46 ± 6·38%, P < 0·001, respectively). The difference in flap survival between the two groups was the most prominent on the ischaemic side following 30 minutes of perforator clamping. From a morphologic perspective, pre‐treatment with bilirubin was found to alleviate perforator flap necrosis caused by I/R injury in this experimental rat model.     

Prevalence of chronic wounds and structural quality indicators of chronic wound care in Dutch nursing homes

The aim of this study was to measure the prevalence of (infected) chronic wounds in Dutch nursing homes and to explore which signs and symptoms are used to diagnose infected chronic wounds. Moreover, it was to determine which structural quality indicators related to chronic wound care at ward and institutional levels were fulfilled. In April 2012, as part of the annual National Prevalence Measurement of Care Problems of Maastricht University [Landelijke Prevalentiemeting Zorgproblemen (LPZ)], a multi‐center cross‐sectional point‐prevalence measurement was carried out together with an assessment of relevant care quality indicators. The prevalence was 4·2%; 16 of 72 (22%) chronic wounds were considered to be infected. Increase of exudate (81·3%; n = 13), erythema (68·8%; n = 11), pain (56·3%; n = 9) and wound recalcitrance (56·3%; n = 9) were considered to be diagnostic signs and symptoms of a chronic wound infection. Although at institutional level most quality indicators were fulfilled, at ward level this was not the case. Despite the relatively low number of residents, we consider our population as representative for the nursing home population. It may be an advantage to appoint specific ward nurses and to provide them specifically with knowledge and skills concerning chronic wounds.     

IPARZINE‐SKR study: randomized,double‐blind clinical trial of a new topical product versus placebo to prevent pressure ulcers

This study compared the efficacy of a new topical agent (IPARZINE‐4A‐SKR) on preventing category I pressure ulcers (PUs) over a 2‐week period, compared with a placebo. A double‐blind, randomised, multi‐centre, placebo‐controlled clinical trial in two parallel groups was conducted. The primary objective was to compare PU incidence between groups. Hospital and socio‐sanitary centre patients (n = 194) at risk of developing a PU (Braden scale) were randomised into two groups. The intervention group included 99 patients, and the placebo group comprised 95 patients. Patients were comparable in terms of age, sex and PU risk. In both groups, patients had a high risk of developing PUs. The product was applied on the sacrum, trochanters and heels. Six PUs (incidence = 6·1%) were detected in the intervention group versus seven (incidence = 7·4%) in the placebo group. Differences were not statistically significant (z = 0·08; P = 0·94), relative risk = 0·82 (95% confidence interval = 0·29–2·36). The main limitation of the study was the sample size and, therefore, the main difficulty encountered was in determining whether the product is ineffective or simply has not been used with sufficient patients. In conclusion, it is not possible to confirm that there are any differences between the studied and the placebo treatments in the prevention of PUs. The results obtained were similar to those obtained in studies of PU prevention using products based on topical fatty acids.     

Pressure ulcers in trauma patients with suspected spine injury: a prospective cohort study with emphasis on device‐related pressure ulcers

Of all patients in a hospital environment, trauma patients may be particularly at risk for developing (device‐related) pressure ulcers (PUs), because of their traumatic injuries, immobility, and exposure to immobilizing and medical devices. Studies on device‐related PUs are scarce. With this study, the incidence and characteristics of PUs and the proportion of PUs that are related to devices in adult trauma patients with suspected spinal injury were described. From January–December 2013, 254 trauma patients were visited every 2 days for skin assessment. The overall incidence of PUs was 28·3% (n = 72/254 patients). The incidence of device‐related PUs was 20·1% (n = 51), and 13% (n = 33) developed solely device‐related PUs. We observed 145 PUs in total of which 60·7% were related to devices (88/145). Device‐related PUs were detected 16 different locations on the front and back of the body. These results show that the incidence of PUs and the proportion of device‐related PUs is very high in trauma patients.     

Diabetic foot disease is associated with reduced erythrocyte deformability

The pathogenesis of diabetic foot disease is multifactorial and encompasses microvascular and macrovascular pathologies. Abnormal blood rheology may also play a part in its development. Using a cell flow analyser (CFA), we examined the association between erythrocyte deformability and diabetic foot disease. Erythrocytes from diabetic patients with no known microvascular complications (n = 11) and patients suffering from a diabetic foot ulcer (n = 11) were isolated and their average elongation ratio (ER) as well as the ER distribution curve were measured. Average ER was decreased in the diabetic foot patients compared with the patients with diabetes and no complications (1·64 ± 0·07 versus 1·71 ± 0·1; P = 0·036). A significant rise in the percentage of minimally deformable red blood cells RBCs in diabetic foot patients compared with the patients with no complications was observed (37·89% ± 8·12% versus 30·61% ± 10·17%; P = 0·039) accompanied by a significant decrease in the percentage of highly deformable RBCs (12·47% ± 4·43% versus 17·49% ± 8·17% P = 0·046). Reduced erythrocyte deformability may slow capillary flow in the microvasculature and prolong wound healing in diabetic foot patients. Conversely, it may be the low‐grade inflammatory state imposed by diabetic foot disease that reduces erythrocyte deformability. Further study of the rheological changes associated with diabetic foot disease may enhance our understanding of its pathogenesis and aid in the study of novel therapeutic approaches.     

Candida albicans colonisation,continence status and incontinence‐associated dermatitis in the acute care setting: a pilot study

Candida albicans is the most prevalent human fungal commensal organism and is reported to be the most frequent aetiological organism responsible for infection associated with incontinence‐associated dermatitis. However, it remains unclear whether incontinence predisposes a patient to increased Candida colonisation or whether incontinence acts as a trigger for Candida infection in those already colonised. The purpose of this observational cross‐sectional study was to estimate colonisation rates of C. albicans in continent, compared to incontinent patients, and patients with incontinence‐associated dermatitis. Data were collected on 81 inpatients of a major Australian hospital and included a pelvic skin inspection and microbiological specimens to detect C. Albicans at hospital admission. The mean age of the sample was 76 years (SD = 12.22) with 53% being male. Incontinent participants (n = 53) had a non‐significant trend towards greater Candida colonisation rates at the perianal site (43% versus 28%) χ²(1, N = 81) = 4·453, p = ·638 and the inguinal site (24% versus 14%) χ²(1, N = 81) = 6·868, p = ·258 compared to continent patients (n = 28). The incontinent subgroup with incontinence‐associated dermatitis (n = 22) showed no difference in colonisation rates compared to those without incontinence‐associated dermatitis. Understanding the epidemiology of colonisation may have implications for the prevention of Candida infection in these patients.     

Adaptive compression therapy for venous leg ulcers: a clinically effective,patient‐centred approach

A prospective, randomised, 12‐week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four‐layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient‐perceived product performance and quality of life. Ulcer healing rate was similar (31·6% versus 42·3%, respectively, P = 0·30) between the treatments. Adverse events and patient‐rated comfort were also similar. Average daily usage for the dual system was 10·5 and 1·8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0·68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0·04), skin protection (P < 0·001), removal ease (P = 0·0007), bathing (P < 0·0001) and sleep comfort (P = 0·0405). The adjusted final quality‐of‐life score was 0·1025 higher for adaptive compression (P = 0·0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0·0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four‐layer bandage management but is better accepted and achieves higher patient‐reported quality‐of‐life scores in these challenging patients.     

Efficacy and cost‐effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings

The aim of this study was to determine the efficacy, safety and cost‐effectiveness of an octenidine‐based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound‐phase‐adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound‐phase‐adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3–5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1–3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost‐effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing.     

Mediastinitis after coronary artery bypass grafting increases the incidence of left internal mammary artery obstruction

Mediastinitis after coronary artery bypass grafting (CABG) gives a longstanding chronic inflammation and has a detrimental negative effect on long‐term survival. For this reason, we aimed to study the effect of mediastinitis on graft patency after CABG. The epidemiologic design was of an exposed (mediastinitis, n = 41) versus non‐exposed (non‐mediastinitis, controls, n = 41) cohort with two endpoints: (i) obstruction of saphenous vein grafts (SVG) and (ii) obstruction of the internal mammary artery (IMA) grafts. The graft patency was evaluated with coronary CT‐angiography examination at a median follow‐up of 2·7 years. The number of occluded SVG in the mediastinitis group was 18·9% versus 15·5% in the control group. Using generalized estimating equations model with exchangeable matrix, and confounding effect of ischaemic time and patients age, we found no significant association between presence of mediastinitis and SVG obstruction [rate ratio (RR) = 0·96, 95% CI (0·52–2·67), P = 0·697]. The number of occluded IMA grafts was 10·5% in the mediastinitis group and 2·4% in the control group. Using the Poisson regression model, we estimated RR = 5·48, 95% CI (1·43–21·0) and P = 0·013. There was a significant association between mediastinitis and IMA graft obstruction, when controlling for the confounding effect of ischaemic time, body mass index, presence of diabetes mellitus and the number of diseased vessels. Presence of mediastinitis increases the risk of IMA graft obstruction. This may confirm the importance of inflammation as a major contributor to the pathogenesis of atherosclerosis and explain the negative effect of mediastinitis on a long‐term survival.     

Quality‐of‐life evaluation in chronic wounds: comparative analysis of three disease‐specific questionnaires

The study directly compared the feasibility and performance of three instruments measuring health‐related quality of life (HRQoL) in chronic ulcers: the Freiburg Life Quality Assessment for wounds (FLQA‐w), the Cardiff Wound Impact Schedule (CWIS) and the Würzburg Wound Score (WWS). The questionnaires were evaluated in a randomly assigned order in a longitudinal observational study of leg ulcer patients. Psychometric properties (internal consistency, responsiveness and construct validity) were analysed. Patient acceptance was recorded. Analysis of n = 154 patients revealed good internal consistency (Cronbach's alpha ≥ 0·85) for all instruments. There were minor floor effects in all questionnaires (<1%) and some ceiling effects in the CWIS. Construct validity was satisfactory, for example, correlation with EuroQoL‐5D was r = 0·70 in the FLQA‐w, r = 0·47/0·67/0·68 in the CWIS dimensions and r = 0·60 in the WWS. The proportion of missing values was higher in the CWIS, and overall patient acceptance was highest in the FLQA‐w for wounds (54% best preferences) and lowest in the WWS (14%). In conclusion, the FLQA‐w, the CWIS and the WWS are reliable, sensitive and valid instruments for the assessment of HRQoL in leg ulcers. However, they show differences in clinical feasibility and patient acceptance.     

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix®) allograft for the treatment of venous leg ulcers

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan–Meier analysis was performed to compare the time‐to‐healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log‐rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25–4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing, full‐thickness venous leg ulcers.     

A randomised controlled trial of the effectiveness of soft silicone multi‐layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial

The prevention of hospital acquired pressure ulcers in critically ill patients remains a significant clinical challenge. The aim of this trial was to investigate the effectiveness of multi‐layered soft silicone foam dressings in preventing intensive care unit (ICU) pressure ulcers when applied in the emergency department to 440 trauma and critically ill patients. Intervention group patients (n = 219) had Mepilex^® Border Sacrum and Mepilex^® Heel dressings applied in the emergency department and maintained throughout their ICU stay. Results revealed that there were significantly fewer patients with pressure ulcers in the intervention group compared to the control group (5 versus 20, P = 0·001). This represented a 10% difference in incidence between the groups (3·1% versus 13·1%) and a number needed to treat of ten patients to prevent one pressure ulcer. Overall there were fewer sacral (2 versus 8, P = 0·05) and heel pressure ulcers (5 versus 19, P = 0·002) and pressure injuries overall (7 versus 27, P = 0·002) in interventions than in controls. The time to injury survival analysis indicated that intervention group patients had a hazard ratio of 0·19 (P = 0·002) compared to control group patients. We conclude that multi‐layered soft silicone foam dressings are effective in preventing pressure ulcers in critically ill patients when applied in the emergency department prior to ICU transfer.     

Adherence to evidence‐based pressure injury prevention guidelines in routine clinical practice: a longitudinal study

The aim of this longitudinal study was to describe adherence to evidence‐based pressure injury (PI) prevention guidelines in routine clinical practice in Australian hospitals. Data were analysed from four control sites of a larger‐cluster randomised trial of a PI intervention. The sample of 799 included 220 (27·5%) Not at risk, 344 (43·1%) At risk and 110 (13·8%) At high risk patients. A total of 84 (10·5%) patients developed a PI during the study: 20 (9·0% of 220) in the Not at risk group, 45 (13·1% of 344) in the At risk group, 15 (13·6% of 110) in the At high risk group and 4 (3·2% of 125) patients who did not have a risk assessment completed. Of all patients, 165 (20·7%) received only one PI prevention strategy, and 494 (61·8%) received ≥2 strategies at some point during the study period. There was no statistical difference in the proportion of time the three risk groups received ≥1 and ≥2 strategies; on average, this was less than half the time they were in the study. Thus, patients were not receiving PI prevention strategies consistently throughout their hospital stay, although it is possible patients' risk changed over the study period.     

Assessment of vacuum‐assisted closure therapy on the wound healing process in cardiac surgery

Postoperative deep sternal wound infection (DSWI) is a serious complication in cardiac surgery (1–5% of patients) with high mortality and morbidity rates. Vacuum‐assisted closure (VAC) therapy has shown promising results in terms of wound healing process, postoperative hospital length of stay and lower in‐hospital costs. The aim of our retrospective study is to report the outcome of patients with DSWI treated with VAC therapy and to assess the effect of contributory risk factors. Data of 52 patients who have been treated with VAC therapy in a single institution (study period: September 2003–March 2012) were collected electronically through PAtient Tracking System PATS and statistically analysed using SPSS version 20. Of the 52 patients (35 M: 17 F), 88·5% (n = 46) were solely treated with VAC therapy and 11·5% (n = 6) had additional plastic surgical intervention. Follow‐up was complete (mean 33·8 months) with an overall mortality rate of 26·9% (n = 14) of whom 50% (n = 7) died in hospital. No death was related to VAC complications. Patient outcomes were affected by pre‐operative, intra‐operative and postoperative risk factors. Logistic EUROscore, postoperative hospital length of stay, advanced age, chronic obstructive pulmonary disease (COPD) and long‐term corticosteroid treatment appear to be significant contributing factors in the long‐term survival of patients treated with VAC therapy.     

Improved detection of clinically relevant wound bacteria using autofluorescence image‐guided sampling in diabetic foot ulcers

Clinical wound assessment involves microbiological swabbing of wounds to identify and quantify bacterial species, and to determine microbial susceptibility to antibiotics. The Levine swabbing technique may be suboptimal because it samples only the wound bed, missing other diagnostically relevant areas of the wound, which may contain clinically significant bacteria. Thus, there is a clinical need to improve the reliability of microbiological wound sampling. To address this, a handheld portable autofluorescence (AF) imaging device that detects bacteria in real time, without contrast agents, was developed. Here, we report the results of a clinical study evaluating the use of real‐time AF imaging to visualise bacteria in and around the wound bed and to guide swabbing during the clinical assessment of diabetic foot ulcers, compared with the Levine technique. We investigated 33 diabetic foot ulcers (n = 31 patients) and found that AF imaging more accurately identified the presence of moderate and/or heavy bacterial load compared with the Levine technique (accuracy 78% versus 52%, P = 0·048; adjusted diagnostic odds ratio 7·67, P < 0·00022 versus 3·07, P = 0·066) and maximised the effectiveness of bacterial load sampling, with no significant impact on clinical workflow. AF imaging may help clinicians better identify the wound areas with clinically significant bacteria, and maximise sampling of treatment‐relevant pathogens.     

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi‐centre,controlled, randomised,blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix^®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.     

Personalized subcutaneous administration of hepatitis B surface antibodies without nucleos(t)ide analogs for patients at risk of renal failure after liver transplantation: a prospective single center cohort study

Currently, nucleos(t)ide analogs (NAs) in monotherapy are favored as prophylaxis against hepatitis B recurrence after liver transplantation. However, in patients at risk of renal failure, renal safety of NAs is of concern. We investigated the safety and efficacy of subcutaneous (SC) hepatitis B immunoglobulins (HBIG) in monotherapy. This is a single‐arm prospective trial in patients transplanted >1 year. We included 43 Caucasian patients. The majority was treated with calcineurin inhibitors, and several patients had other risk factors for renal impairment as well: diabetes mellitus (n = 10/43), arterial hypertension (n = 11/43), and hyperlipidemia (=10/43). At inclusion, 42% (n = 18) had chronic kidney disease ≥ grade 3a. All patients were switched from IV HBIG with or without NAs to SC HBIG without NAs. After one year, the targeted titer was lowered to ≥150 IU/l in patients with low risk of recurrence. Mean follow‐up time was 36 ± 5 months. None of the patients had a relapse of HBsAg or HBV DNA. The treatment was well tolerated, safe and the renal function remained unchanged both in patients with (n = 18) or without (n = 25) renal impairment at baseline. The mean HBsAb titer could be decreased from 343 ± 163 to 199 ± 81 IU/l in the low‐risk group (n = 17) and 218 ± 71 IU/l in the high‐risk group (n = 26). In 86% (n = 37) doses, reductions were possible, which significantly lowered the cost of treatment. SC HBIG without NAs had a 100% success rate in the long‐term prevention of HBsAg and HBV DNA reappearance, without deterioration of renal function.