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A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
High specification mattresses periodically redistribute pressure using alternating air cells, offloading tissues. This study aimed to evaluate the effects of alternating air pressure gradients on sacral tissue physiology. This randomised cross-over study recruited 15 healthy participants to test the three mattress settings (fast cycle, normal cycle, and slow cycle). Participants were asked to adopt supine, lateral, and high sitting (head of bed at 40°) postures, whilst transcutaneous tissue gas tensions and interface pressures at the sacrum were continuously monitored. Comparison between mattress settings and postures showed no statistical difference (p > 0.05) between peak pressure index values at the sacrum for each air inflation cycle speed setting. By contrast, a significantly higher sacral (p < 0.05) contact area was observed for high sitting. During high sitting, ischemic responses during both fast and normal air inflation cycle speed settings were recorded. During the slow air inflation cycle speed, most participants (60%–100%) showed high levels of perfusion. The present study identified a main effect of posture on interface pressure and perfusion over the sacrum. The alternating mattress speed influenced local tissue perfusion, with the greatest changes in tissue oxygenation occurring in a high-speed setting.
Diabetes related foot ulcers (DFUs) are complex and costly to manage, with the prevalence of non-healing wounds steadily increasing across the globe. Non-healing wounds can occur when clinicians fail to undertake an appropriate assessment, fail to recognise the importance of systemic or local complications, or provide the optimal treatment. The aetiological causes behind non-healing wounds are multifactorial; however, the purpose of this article is to focus on the role of oxygen in non-healing wounds and to introduce readers to advances in the delivery of topical oxygen therapy (TOT) via a haemoglobin spray. Importantly, this article incorporates a clinical decision support tool (CDST) to help clinicians identify the most appropriate individuals for whom topical haemoglobin may be most beneficial and the most appropriate time for introducing the intervention to improve wound healing outcomes.
Closed incision negative pressure therapy (ciNPT) with foam dressings has received broad recognition for its ability to support incision healing for a variety of surgical procedures. Over time, these dressings have evolved to include linear and ‘area’ shapes to better conform to different incision types and surface geometries. To address new studies on these configurations and provide guidance for dressing selection, an international, multidisciplinary panel of experts was convened. The panel reviewed recent publications on ciNPT with reticulated open cell foam (ROCF) dressings, shared their cases and experiences and engaged in roundtable discussions on benefits, drawbacks and technical challenges. Topics were ranked by importance and refined into potential consensus statements. These were shared for anonymous feedback, requiring 80% agreement for consensus. This manuscript establishes 12 consensus statements regarding risk factors supporting the use of ciNPT, conditions supporting preference of linear or area ciNPT dressings and tips for practical application of ciNPT with ROCF dressings. While this consensus panel expands on previous publications to aid clinicians' decision-making, further research is needed to refine recommendations and identify the strengths and limitations of ciNPT. Continued multidisciplinary collaboration will ensure ciNPT remains vital for improving surgical outcomes and patient care.
To develop a concise Consensus Statement on the management of venous leg ulcers (VLUs) that incorporates existing standards and guidance on new technology, including improvement of calf muscle pump function and the utilisation of advanced wound therapies. A multidisciplinary panel of 19 wound healthcare providers from across Canada, who treat patients with VLUs, was formed. A draft document was created and four rounds of consultation and feedback were sought from the panel. The Consensus Statement was completed in June 2024 with 100% consensus on 20 sections and > 85% consensus on the remaining three sections. The key elements are—Clinical assessment and investigations; Treatment-compression to improve calf muscle pump function, and wound treatment with the principles of Wound Bed Preparation; When not healing or only suboptimal compression can be used - add treatment with muscle pump activator by continuous Neuromuscular Electrical Stimulation of the common peroneal nerve to improve calf muscle pump function; When VLUs are not healing with optimal therapy - an algorithm for the use of advanced wound therapies; and Prevention of VLU recurrence. The Consensus Statement is a concise guide for healthcare providers to use at the bedside and has been endorsed by leading nursing and homecare associations in Canada that also have physician representation.
As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).
Complex, chronic or hard-to-heal wounds are a prevalent health problem worldwide, with significant physical, psychological and social consequences. This study aims to identify factors associated with the healing process of these wounds and develop a mobile application for wound care that incorporates these factors. A prospective multicentre cohort study was conducted in nine health units in Portugal, involving data collection through a mobile application by nurses from April to October 2022. The study followed 46 patients with 57 wounds for up to 5 weeks, conducting six evaluations. Healing time was the main outcome measure, analysed using the Mann–Whitney test and three Cox regression models to calculate risk ratios. The study sample comprised various wound types, with pressure ulcers being the most common (61.4%), followed by venous leg ulcers (17.5%) and diabetic foot ulcers (8.8%). Factors that were found to impair the wound healing process included chronic kidney disease (U = 13.50; p = 0.046), obesity (U = 18.0; p = 0.021), non-adherence to treatment (U = 1.0; p = 0.029) and interference of the wound with daily routines (U = 11.0; p = 0.028). Risk factors for delayed healing over time were identified as bone involvement (RR 3.91; p < 0.001), presence of odour (RR 3.36; p = 0.007), presence of neuropathy (RR 2.49; p = 0.002), use of anti-inflammatory drugs (RR 2.45; p = 0.011), stalled wound (RR 2.26; p = 0.022), greater width (RR 2.03; p = 0.002), greater depth (RR 1.72; p = 0.036) and a high score on the healing scale (RR 1.21; p = 0.001). Integrating the identified risk factors for delayed healing into the assessment of patients and incorporating them into a mobile application can enhance decision-making in wound care.
A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
Venous ulcers affect up to 3% of the global population, with a high impact on economies and quality of life. This is exacerbated by its recurrence rates, which reach 70% at 12 months after healing. The perpetuation of these cycles of healing and recurrence is not interrupted or even attenuated by the self-care activities recommended and directed toward their prevention. In this context, we sought to identify the effectiveness of interventions that promote adherence to self-care to prevent venous ulcer recurrence. In August 2022, we conducted a literature search via EBSCO in the following databases: CINAHL Complete, MEDLINE Complete, Cochrane Database of Systematic Reviews, Scopus, and Web of Science. The inclusion criteria were researched in the form of randomised controlled trials or systematic literature reviews, and 99 studies were identified. During the different times of selection, four studies met the defined inclusion criteria and were included. As the main conclusions, the emphasis goes to the importance of the use of compression and the greater effectiveness of higher compression classes for the prevention of recurrence. Different educational methodologies seem to be important to increase knowledge about prevention, specifically regarding the aetiology of recurrence and the implementation of prevention measures.
Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.
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