Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures.

OBJECTIVE: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). METHOD: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. RESULTS: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60-253) days in the MCB group versus 137 (IQR: 68-300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. CONCLUSION: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.

Prevention of pressure injuries using a non-motorised decompression air mattress: a non-interventional study.

OBJECTIVE: Prevention of pressure injuries (PI) is a public health issue. Among the preventive measures, the use of support surfaces adapted to the risk of PI occurrence is recommended. This study aimed to report the incidence of PIs in patients at medium-to-high risk of occurrence of PIs and using a new non-motorised automated decompression air mattress combined with other recommended PI prevention measures. METHOD: An observational, national, multicentre, prospective, non-comparative study, with a follow-up period of 35 days was conducted. Patients at medium-to-high risk of PIs and without PIs at baseline were included if they were lying on a specific non-powered automated decompression air mattress. The primary outcome was the percentage of patients who developed at least one category 2 or more severe PI of the sacrum, backbone or heel between day 0 and day 35. RESULTS: In total, 81 patients were included from four participating centres. There was one report of a patient with a PI that fitted within the definition of the primary outcome, meaning an incidence of 1.2% (95% confidence interval (CI) 0-6.7%). More than 80% of patients rated the overall comfort and the stability of the non-motorised automated decompression air mattress as satisfactory or very satisfactory. In more than 80% of cases, the healthcare teams found the use of the mattress to be easy or very easy. CONCLUSION: This study has shown that in combination with other preventive measures, the use of a specific non-motorised air mattress with automated decompression is associated with a low incidence of PIs in patients with medium-to-high risk of occurrence of PIs.

Healico-a wound care assistant in your pocket.

Non-optimal wound management and late referral to specialised units negatively impacts patient prognosis and quality of life, as well as healthcare costs. Healico is a new mobile application (app), created in the wound care field, in response to the challenges and difficulties encountered by health professionals (HPs) who deal with patients with wounds on a daily basis. This article aims to describe how this new app was developed, how it works, as well as the real-life clinical benefits and evidence supporting its use. The Healico App assists nurses, physicians and other HPs by: supporting a holistic approach to patient management; facilitating wound assessment and documentation, irrespective of where care is provided (primary, specialised or hospital services, in either public or private institutions); and supporting consistent and safe clinical practice, as well as reducing variation in care. It also provides a fast, fluid and secure communication channel, and effective coordination between HPs, supporting early interventions. The app has also been shown to improve therapeutic adherence of patients by promoting inclusive dialogue with them.

The diagnosis, management and prevention of intertrigo in adults: a review.

Intertrigo is a common inflammatory skin disorder caused by skin-on-skin friction in skin folds, due to moisture becoming trapped because of poor air circulation. This can occur in any area of the body where two skin surfaces are in close contact with each other. The aim of this scoping review was to systematically map, review and synthesise evidence on intertrigo in adults. We identified a wide range of evidence and performed a narrative integration of this related to the diagnosis, management and prevention of intertrigo. A literature search was conducted within the following databases: Cochrane Library, MEDLINE, CINAHL, PubMed and EMBASE. After reviewing articles for duplicates and relevance, 55 articles were included. The incorporation of intertrigo in the ICD-11 provides a clear definition and should improve the accuracy of estimates. With regards to the diagnosis, prevention and management of intertrigo, the literature demonstrates consensus among health professionals in approach and this forms the basis for the recommendations of this review: identify predisposing factors and educate patient in reducing these; educate patients in skin fold management and adopt structured skin care routine; treat secondary infection with appropriate topical agent; consider using moisture-wicking textiles within skin folds to reduce skin-on-skin friction, wick away moisture and reduce secondary infection. Overall, the quality of evidence on which to determine the strength of any recommendations for practice remains low. There remains the need for well-designed studies to test proposed interventions and build a robust evidence base.

Anti-biofilm Activity of Povidone-Iodine and Polyhexamethylene Biguanide: Evidence from In Vitro Tests.

Biofilm in chronic wounds is associated with delayed healing and ineffective local treatment. The purpose of this study was to investigate the in vitro anti-biofilm activity of two commonly used antimicrobials, povidone-iodine (PVP-I) and polyhexamethylene biguanide (PHMB). The rate of anti-biofilm activity of PVP-I, PHMB, and phosphate-buffered saline (negative control) was assessed on monomicrobial biofilms of varying maturity and composition. Antimicrobial efficacy was determined by counting colony-forming units (CFU). Live/dead cell staining and time-lapse confocal microscopy were also performed. Both PVP-I and PHMB demonstrated robust in vitro anti-biofilm activity against all tested biofilms; however, PVP-I had a more rapid action versus PHMB against methicillin-resistant Staphylococcus aureus (MRSA) biofilms, as determined by both CFU counts and microscopy. PVP-I completely eradicated Pseudomonas aeruginosa biofilms of 3- and 5-day maturity (in ≤0.5 h) and 7-day maturity (in ≤3 h), while PHMB only partially depleted cell density, with no complete biofilm eradication even after 24 h. In conclusion, PVP-I had a similar in vitro anti-biofilm activity to PHMB against biofilms of varying microbial compositions and maturity, and in some cases demonstrated more potent and rapid activity versus PHMB. PVP-I may be particularly effective in treating MRSA biofilms. However, further high-quality clinical research on the efficacy of antimicrobials is required.

Avant-propos.

Hard-to-heal wounds are a problem for both patients and caregivers. The biofi lm is one of the local factors of delayed healing. Wound hygiene carried out in 4 steps (cleansing, debridement, refashion - care of the edges, and dressing) constitutes the basis of proactive and curative anti-biofi lm strategies.

Calcified Leg Ulcers in Older Patients: Clinical Description, Morphology, and Chemical Characterization.

Chronic wounds, including leg ulcers, constitute an important medical problem among older patients. Dystrophic calcifications (DC) are associated with a variety of disorders, including leg ulcers. The aim of this study was to report the clinical and biological characteristics of older patients with DC in leg ulcers and to determine the morphology and chemical composition of these calcifications. We conducted a prospective monocentric study in our Geriatric-Wound and Healing ward, Rothschild Hospital, Paris, from January 2018 to December 2019. Patients with leg ulcers were screened for DC by palpation. Patients' clinical, biological, and radiological findings were collected. DC morphology was analyzed using field-emission scanning electron microscopy and chemical composition was analyzed using µFourier transform infra-red spectroscopy and X-ray Fluorescence. Ten (7%) of the 143 patients hospitalized for leg ulcers presented DC. Older patients with DC were more likely to have leg ulcers with venous insufficiency (p = .015), colonized by Pseudomonas aeruginosa (p = .026), with a longer healing evolution (p = .0072) and hypercalcemia (p = .041). Five DC were extracted from ulcers: 2 presented 500 nm lacunar spheres and intermingled fibrils of about 10 nm in diameter, consistent with bacterial and biofilm imprints. DC were always composed of calcium-phosphate apatite and associated to the presence of zinc. Our analyses were consistent with the involvement of microorganisms and inflammatory process in DC formation. Early management of venous insufficiency, treatment of chronic bacterial colonization and use of calcium-solubilizing drugs seem to be rational strategies for calcified leg ulcer management in older patients.

Prevalence and risk factors of dermatoporosis in older adults in a rehabilitation hospital.

BACKGROUND: The term dermatoporosis (DP) is used to describe the clinical signs and functional consequences of age-related extreme skin fragility. It is associated with potentially severe complications, including deep dissecting hematomas and extended skin lacerations. No studies have evaluated the prevalence and risk factors of DP in adults aged 75 and older. METHODS: The aim of our study was to assess the prevalence, complications, and risk factors of DP in a cohort of older patients hospitalized in a rehabilitation center. A case-control, single-center study was conducted between September and October 2020 in our rehabilitation ward, Rothschild Hospital, Paris, France. A senior dermatologist and a resident in geriatric medicine performed a systematic dermatological examination. The presence of DP, its stage, its location, and complications were collected, as were demographical data, comorbidities, past sun exposure, skin phototype, treatments, and biological data. RESULTS: A total of 101 patients (62 women, median age 86 years [extreme values 75-104]) were included. The overall prevalence of DP was 27%. Stage 1 was the most frequent. DP was mainly located on the upper limbs. Ten (37%) patients had a DP complication: eight (30%) skin lacerations and two (7%) deep dissecting hematomas. Multivariate analysis revealed a significant association between DP and age (odds ratio [OR] 5.82, 95% confidence interval [CI] 1.67-24.92, p = 0.009), smoking (OR 8.67, 95% CI 2.59-34.85, p = 0.001), recreational sun exposure (OR 4.23, 95% CI 1.30-15.21, p = 0.02), and anticoagulant therapy (OR 4.53, 95% CI 1.32-17.26, p = 0.02). CONCLUSION: Our study is the first to analyze the prevalence and risk factors of DP in older adults in rehabilitation. Frequency of DP makes it relevant for the geriatrician and should be described more to prevent potential severe complications. A multicentric study, with inpatients and outpatients, could evaluate the prevalence of DP in a more representative older adult population.

Use of multilayer silicone foam dressings as adjuvant therapy to prevent pressure injuries.

Despite progress in the prevention of pressure injuries (PIs), they remain a challenging public health problem because of their frequency and morbidity. Protection of the skin by multilayer silicone foam dressings may be an adjuvant measure to prevent PIs in high-risk patients. Despite the available clinical data and published recommendations on this measure, caregivers face difficulties in identifying patients who would benefit from this adjuvant measure. The objective of this work was to define the profiles of high-risk patients who would benefit optimally from this measure in combination with basic preventive procedures. This consensual expert opinion was drawn up using two methods: the Nominal Group Technique with eight medical and paramedical experts, and the Delphi process with 16 experts. The bases for this expert consensual opinion were a formal search and analysis of the published literature regarding evidence on the prevention of PIs using multilayer silicone foam dressings. The consensual expert opinion reported here addresses five proposals mostly intended to define patients who would benefit from the use of a multilayer silicone foam dressing (≥4 layers) to prevent PIs (sacrum and heels).

Incidence of pressure ulcer in patients using an alternating pressure mattress overlay: the ACTIVE study.

OBJECTIVE: The primary objective was to determine the clinical benefit of using a specific alternating-pressure mattress overlay (APMO) in the prevention of pressure ulcer (PU) in patients at medium to high risk. METHOD: This prospective study was conducted in five rehabilitation centres and three nursing homes. Patients at medium to high risk of PU, but without PU at baseline, and lying between 15 and 20 hours per day on a specific APMO were included. The primary endpoint was the percentage of patients who developed a sacral, spine, heel or trochanteric PU (supine support areas) of at least category II, at day 35. All patients were included in the analysis. RESULTS: A total of 89 patients were included; of whom six patients (6.7%) dropped out of the study (average (±standard deviation) follow-up 32±5.4 days). No sacral, spine, heel or trochanteric PU of at least category II was reported (i.e., an incidence of 0% [95% Confidence Interval: 0-4.1%] according to the exact Clopper-Pearson method]. Patients were 'satisfied' or 'very satisfied' with the comfort and stability of the APMO. The caregivers assessed as 'very easy' or 'easy' the implementation, maintenance and use of the APMO (turning over, moving to a sitting position). CONCLUSION: In combination with the usual measures to prevent PU, the results of our study showed a low incidence of PU in high-risk patients lying for between 15 and 20 hours a day on an APMO, use of which is therefore recommended in these patients.

Update on the role of antiseptics in the management of chronic wounds with critical colonisation and/or biofilm.

Biofilms play a major role in delaying chronic wounds from healing. A wound infiltrated with biofilm, or "critically colonised" wound, may become clinically infected if the number of microbes exceeds a critical level. Chronic wound biofilms represent a significant treatment challenge by demonstrating recalcitrance towards antimicrobial agents. However, a "window of opportunity" may exist after wound debridement when biofilms are more susceptible to topical antiseptics. Here, we discuss the role of antiseptics in the management of chronic wounds and biofilm, focusing on povidone-iodine (PVP-I) in comparison with two commonly used antiseptics: polyhexanide (PHMB) and silver. This article is based on the literature reviewed during a focus group meeting on antiseptics in wound care and biofilm management, and on a PubMed search conducted in March 2020. Compared with PHMB and silver, PVP-I has a broader spectrum of antimicrobial activity, potent antibiofilm efficacy, no acquired bacterial resistance or cross-resistance, low cytotoxicity, good tolerability, and an ability to promote wound healing. PVP-I represents a viable therapeutic option in wound care and biofilm management, with the potential to treat biofilm-infiltrated, critically colonised wounds. We propose a practical algorithm to guide the management of chronic, non-healing wounds due to critical colonisation or biofilm, using PVP-I.

Acceptability of oral liquid pharmaceutical products in older adults: palatability and swallowability issues.

BACKGROUND: In institutional care, oral liquid pharmaceutical products are widely prescribed for older patients, especially for those with swallowing disorders. As medicines acceptability is a key factor for compliance in the older population, this study investigated the acceptability of oral liquid pharmaceutical products in this targeted population. METHODS: An observational, multicenter, prospective study was conducted in eight geriatric hospitals and eight nursing homes in France. Observers reported several behaviours/events describing the many aspects of acceptability for various pharmaceutical products' uses in patients aged 65 and older. Acceptability scores of oral liquid pharmaceutical products were obtained using an acceptability reference framework (CAST - ClinSearch Acceptability Score Test®): a 3D-map summarizing the different users' behaviors, with two clusters defining the positively and negatively accepted profiles materialized by the green and red zones, respectively. RESULTS: Among 1288 patients included in the core study and supporting the acceptability reference framework, 340 assessments were related to the administration of an oral liquid pharmaceutical product. The mean age of these patients was 87 (Range [66-104y]; SD = 6.7), 68% were women and 16% had swallowing disorders. Globally, the oral liquid pharmaceutical products were classified as "positively accepted," the barycenter of the 340 assessments, along with the entire confidence ellipses surrounding it, were positioned on the green zone of the map. Sub-populations presenting a different acceptability profile have also been identified. For patients with swallowing disorders, the oral liquid pharmaceutical products were classified as "negatively accepted," the barycenter of the 53 assessments along with 87% of its confidence ellipses were associated with this profile. A gender difference was observed for unflavored oral liquids. In women, they were classified "negatively accepted," the barycenter of the 68 assessments with 75% of its confidence ellipses were located in the red zone, while they were classified "positively accepted" in men. CONCLUSION: This study showed that oral liquid pharmaceutical products are a suboptimal alternative to solid oral dosage forms in patients with swallowing disorders. To ensure an optimal acceptability, prescribers should also consider the presence of a taste-masker in these oral liquids. As highlighted herein, palatability remains crucial in older populations, especially for women.

Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single-arm, prospective, open-label clinical trials.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new TLC-NOSF dressing with poly-absorbent fibres in the management of exuding leg ulcers, at the different stages of healing. METHOD: This work presents the results of two prospective, multicentric clinical studies: NEREIDES and CASSIOPEE. Patients with a non-infected, moderate-to-strongly exudating leg ulcer of venous or mixed origin, were treated with the dressing and an appropriate compression system for 12 weeks. The wounds included in NEREIDES had to be in debridement stage, and those in CASSIOPEE at granulation stage. In both studies, the primary outcome was the relative wound area reduction (RWAR) at week 12. Main secondary outcomes included healing rate, time-to-reach wound closure, adverse events and acceptability of the dressing by patients and health professionals. RESULTS: There were 37 patients included in NEREIDES and 51 in CASSIOPEE. The two cohorts presented similar patient and wound characteristics, except from the percentage of sloughy tissue on wound bed at baseline (median: 75% NEREIDES and 30% CASSIOPEE). At week 12, the RWAR (60% NEREIDES and 81% CASSIOPEE), wound closure rates (18% NEREIDES and 20% CASSIOPEE) and mean times-to-reach wound closure (58±27 days NEREIDES and 55±23 days CASSIOPEE) supported the beneficial outcomes of the treatment in both cohorts. In patients with a wound duration ≤6 months, the wound area reduction reached 85% in NEREIDES and 81% in CASSIOPEE, highlighting the importance to initiate adequate treatment as soon as possible. The nature and frequency of the local adverse events were similar in both studies and consistent with the good safety profiles of the poly-absorbent fibres and of the TLC-NOSF dressings. The acceptability of the dressing (easy to apply, conformable and non-adherent to the wound bed at removal, with no pain or bleeding at removal) has been judged 'very good' or 'good' at each stage of the healing process, by both nursing staff and patients. CONCLUSION: These clinical results establish the new TLC-NOSF dressing with poly-absorbent fibres (UrgoStart Plus, Laboratoires Urgo) as an effective, safe and simple treatment for the local management of leg ulcers, at the different stages of healing and until wound closure.

Impregnated acetate gauze compared with lipido-colloid contact layer at dressing removal pain: a single-blind cross-over randomised control trial.

OBJECTIVE: To evaluate the performance of Jelonet Plus (JP) and UrgoTul (UT), assessing pain at dressing removal when managing acute or chronic wounds at granulation and epithelialisation stages. METHODS: This was a randomised, multicentre, controlled single-blinded study using a cross-over design. Hospitalised and ambulatory patients presenting with non-infected acute or chronic wounds (at least 40% of wound area of ≤100cm2 covered with granulation tissue) were randomly allocated to be treated with either JP or UT dressings applied according to a standardised local care procedure for two days. At the following visit, patients received the other dressing for a second 2-day period. Pain was evaluated after two days of dressing application and immediately after its removal using a 100mm Visual Analog Scale (VAS). A pain level >30mm was considered as clinically relevant. A lower limit of -12% was determined as the threshold necessary to demonstrate the non-inferiority of JP compared to UT. RESULTS: For the 99 patients completing the study, a difference of 7.9% was observed in favour of JP (83.8% JP versus 75.9% UT) for pain immediately after dressing removal (VAS score < 30mm) with a confidence interval (CI) lower limit of -2.6%, demonstrating non-inferiority (pre-defined limit of -12%). Concerning pain at dressing removal, a difference of 19.6% was observed in favour of JP (81.6% versus 62.0%; p=0.029 for superiority analysis), with a CI lower limit ranging from 2.4% to 38.9%. Therefore, superiority could be concluded. A statistically significant period effect was detected (p=0.003) with fewer patients experiencing pain after the second period day 2 (D2) to day 4 (D4) than the first day 0 (D0) to D2. A statistically significant cross-over effect was also detected (p=0.047), with fewer patients experiencing pain when JP was applied first followed by UT. This suggests a carry-over effect thus preventing a full cross-over design analysis. Adherence of the dressing was less frequent with the JP than the UT dressing (2.0% JP versus 6.9% with UT). CONCLUSION: Non-inferiority of pain at dressing removal was demonstrated with JP. Superiority on this criteria was non-significant but we found adherence of the dressing to the wound bed to be more rare.

Silver Sulfadiazine and Cerium Nitrate in Ischemic Skin Necrosis of the Leg and Foot: Results of a Prospective Randomized Controlled Study.

Flammacerium is a topical treatment composed of silver sulfadiazine and cerium nitrate initially used in burns. The objective was to assess the effectiveness of silver sulfadiazine and cerium nitrate on ischemic necrosis wounds of the lower limb as an alternative to amputation for a period of 12 weeks. Patients were prospectively randomized to receive silver sulfadiazine and cerium nitrate or standard care. Patients included adults with an ischemic wound of the lower limb, with necrosis covering over at least 50%. Critical ischemia limb was confirmed by an ankle-brachial index <0.7 or >1.3 with radiological confirmation. Patient demographic data, amputations procedures, wound area, Visual Analogue Scale pain rating, clinical infection, and adverse events were recorded. Fifty patients, 34 males and 16 females, were recruited between January 2010 and April 2014, 25 in each group. The mean age was 75.14 years (±11.64). Nine amputations (36%) occurred in each group. Amputation-free survival was superior in the active treatment group versus the standard group (169 393 days, 95% confidence interval = 134.926-203.861, vs 169 393 days, 95% confidence interval = 134.926-203.861). It was not statistically significant (log-rank, P = .958). Wound area reduction between both groups was not statistically different ( P = .651). Less adverse events of the lower limb occurred in the active treatment group ( P = .001). Our study showed that silver sulfadiazine and cerium nitrate is not inferior to standardized care on ischemic necrotic wounds of the lower extremity. Further studies are still needed to confirm its effectiveness.