Conectar
There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.
This study investigates cortical reorganisation and hemodynamic responses in individuals with lower extremity amputation and replantation using functional near-infrared spectroscopy (fNIRS). A total of 15 healthy controls, four left lower limb amputees and one replantation patient were included. Oxyhemoglobin (oxy-Hb) activations were measured during 10 unilateral lower limb motor tasks (toe, ankle, knee and hip movements). Non-parametric analyses revealed significant differences in cortical activation between amputees and controls, particularly during knee flexion and extension. Three-dimensional contrast maps demonstrated that oxy-Hb activity in amputees extended from the M1-leg area into somatosensory regions, reflecting neuroplastic remapping. In contrast, the replantation patient exhibited activation patterns closer to the control group, especially in knee and hip tasks. These findings indicate that fNIRS can sensitively capture hemispheric dynamics during unilateral lower limb movements and highlight neuroplastic adaptations following amputation and replantation. Such insights may guide future neuroprosthetic design and rehabilitation strategies.
The article describes the outcomes of a single-centre investigation on the use of OZOILE to improve the healing process in patients with chronic diabetic ulcers. This is a non-randomised interventional study which aims to assess the differences between two groups (total 200 patients) by evaluating healing time at 15, 30, 45, 60, 75 and 90 days. Pain assessment with VAS scale at 15, 30 and 45 days, biofilm test and tissue regeneration by histological evaluation were also taken into consideration. The outcomes show faster healing, reduced pain, control of local infection, aesthetically pleasing and qualitatively better healing. Our treatment strategy involves applying OZOILE detergent without rinsing, Ozoile spray oil and Ozoile cream followed by a non-adherent dressing (paraffin gauze). This integrated protocol shows a safe and effective treatment for diabetic chronic wound healing in a cost-effective manner. The group treated with the Rigenoma/Ozoile protocol demonstrated significantly superior outcomes compared to the control group, including accelerated healing, reduced pain levels, effective management of unpleasant odour, and high levels of compliance from both patients and surgeons. Overall, Ozoile markedly reduced healing time compared with standard care, with results robust across multiple analytical approaches.
EPIFIX, a dehydrated human amnion/chorion membrane allograft, received regulatory approval as a medical device in 2021 by the Ministry of Health, Labour and Welfare following review by the Pharmaceuticals and Medical Devices Agency, for the treatment of refractory ulcers, including diabetic foot ulcers. Insurance reimbursement under the Japanese national health insurance system was approved in 2022. This study investigated the efficacy of EPIFIX for diabetic foot ulcers in Japan. This study included 55 patients who were treated with EPIFIX after debridement, evaluating the treatment duration and wound outcomes. Treatment was considered complete upon successful wound closure (i.e., reconstruction or epithelialization) or when adverse events (i.e., wound infection, death, or other complications) occurred. The wounds were classified as either healed or nonhealed. Wound healing was observed in 43 patients. Comparing the patients with healed and non-healed wounds, there was a significant difference in the presence of chronic kidney disease (G5d), coronary artery disease, and certain laboratory findings (albumin, C-reactive protein, white blood cell count, and haemoglobin) (p < 0.05). The treatment duration was similar between the healed and non-healed groups (24.39 vs. 24.83 days, p = 0.14). Wound bed preparation and an improved general health condition were key factors for healing. EPIFIX promotes wound healing in diabetic foot ulcers, although careful patient selection is essential to maximise its effectiveness.
Hard-to-heal wounds are frequently associated with underlying conditions such as diabetes, vascular disease, and biofilm-related infections. Accurate identification of microbial origin is essential, but is often hindered by biofilms. This study evaluated whether sonication of wound dressings, combined with different sample transport methods, improves bacterial detection in venous leg ulcers. In a prospective observational case–control study, six patients with hard-to-heal venous leg ulcers received treatments with medical-grade honey (MGH) (n = 1), ceramic dressings – “Cerdak” (n = 2), or hydroactive dressings (n = 3). Three microbiological samples were collected per patient: (1) conventional wound swab (Levin's technique) in Amies medium; (2) sonicate fluid from used dressings transported in sterile tubes without medium; and (3) sonicate fluid in haemoculture tubes (BACT/ALERT). Total pathogen count and diversity were compared across sampling methods. Patient quality of life (QoL) was assessed using the Wound-QoL instrument. Sonication revealed additional pathogens not detected by conventional swabs. The highest number of pathogens was found in sonicate fluid transported in haemoculture tubes (n = 43), followed by swabs (n = 39) and sterile tube transport (n = 30). Adequate treatment significantly improved patients' QoL during the healing process. Dressing sonication, especially with haemoculture tube transport, enhances microbial identification and may improve diagnosis and management of hard-to-heal wounds.
This study evaluates the predictive value of the WIfI (Wound, Ischemia, and foot Infection) classification system and pre-amputation transcutaneous oxygen pressure (TcPO2) measurements in forecasting post-amputation complications in major lower limb amputations (MLLA). A retrospective analysis was conducted on 132 MLLA patients with complete WIfI data and 87 patients with documented TcPO2 values. Associations between WIfI stage, TcPO2, and post-amputation outcomes—including healing time, surgical revisions, re-amputation, and wound complications—were assessed using statistical modeling and receiver operating characteristic (ROC) curve analyses. Higher WIfI stages correlated with prolonged healing (WIfI 4 failure rate: 12.8%) but did not significantly predict complications. Unexpectedly, WIfI 2 patients had a 4.4-fold higher risk of revision (p = 0.011) and a 3.1-fold higher re-amputation risk (p = 0.033) compared to WIfI 4. TcPO2 levels showed a significant relationship with healing outcomes, with a 36.9% failure rate in TcPO2 < 15 mmHg. A TcPO2 cut-off of > 46 mmHg optimized healing prediction (HR = 2.81, p = 0.004). TcPO2 is a stronger predictor of post-amputation complications than WIfI staging. A cut-off of > 46 mmHg at the amputation site is recommended to improve healing outcomes.
Diabetic foot ulcers (DFUs) are severe complications of diabetes that often lead to major amputations. Despite care advancements, approximately 50% of minor amputations do not heal, resulting in major amputations and increased mortality. This study evaluated the effectiveness of adipose-derived stem cells (ASCs) obtained through superficial enhanced fluid fat injection (SEFFI) in improving healing rates after minor amputations in DFUs. It was a prospective, single-arm, observational cohort study. The patients were monitored for half a year using monthly assessments. The primary endpoint was the healing rate of the amputation stumps after minor amputations coupled with ASC injections. Secondary endpoints included safety, feasibility, adverse events and analysis of variables associated with healing including the analysis of the injected mesenchymal adipose stem cell populations. Of the 256 screened patients, 40 were enrolled. At 6 months, 55% of the treated stumps had healed completely. The median healing time was 69 days. Technical success was achieved in all cases without device-related complications. Multivariable Cox models identified haemodialysis, opioid use and the injected number of CD45-positive cells as risk factors for healing failure. CD73 expression was positively associated with healing. The SEFFIDiFA trial demonstrated a promising 69% healing probability at 6 months post-amputation. This minimally invasive approach showed a higher healing rate with fewer complications. This study supports the potential of ASCs in enhancing wound healing in DFUs and highlights the importance of CD73 expression for successful outcomes. Further research is warranted to validate these findings and optimise the technique.
This study aimed to determine if skin types can be accurately assessed via melanin scores measured with a colormeter, and whether scar characteristics of people with different skin types are different at various stages of healing. Melanin scores of a Cortex DSM Colormeter were validated against the Fitzpatrick skin type questionnaire in healthy volunteers and unaffected skin of burn and scar patients (N = 137) to determine melanin index cut-offs per skin type. Scar quality in children and adults at 3, 6, and 12 months post-burn using DSM Colormeter and the Patient and Observer Scar Assessment Scale (POSAS) was analysed in a cohort of > 1000 patients. Data from 137 individuals showed good correlation between melanin index and Fitzpatrick skin types (Spearman's rho: 0.72 Dermaspectrometer, 0.69 DSM II; p < 0.0001). Scar characteristics varied by skin type for erythema, pigmentation, vascularization, and overall POSAS scores. Children had significantly thicker scars than adults, regardless of skin type, varying from 0.3 to 1.4 points difference on the observer scale at 12 months post burn. We conclude that skin type can be objectively classified using the melanin index, showing a strong correlation with the Fitzpatrick questionnaire. Skin type influences scar outcomes, especially pigmentation and vascularization. Children, particularly those with lighter skin, tend to develop thicker scars than adults. Recognising these differences can improve scar management and patient education.
The aim of this study was to assess the performance and safety of daily treatment with a 0.2% hyaluronic acid-based hydrogel (Hyalo4 Skin Gel) in patients with chronic and acute wounds. The primary endpoint was the amelioration rate after 14 days of treatment, defined as the percentage of patients showing improvement in at least one of the following wound characteristics: wound tissue type, exudate amount, or type. Secondary endpoints included assessments of the treatment's effects on wound bed type, exudate amount and type, and patients' quality of life (EQ-5D QoL), as well as its safety and ease of application. Data were collected up to 56 days of treatment. A total of 170 patients were enrolled. Wound bed amelioration was observed in 46.0% of the patients after 14 days. The amelioration rate increased from 0.291 after 7 days to 0.561 after 56 days. The treatment promoted wound healing, increased granulation tissue formation, and normalized exudate levels. Additionally, QoL significantly improved, and the product was deemed easy to apply and safe, with no serious treatment-related adverse events reported. Being effective in enhancing the re-epithelialization of both acute and chronic wounds, Hyalo4 Skin Gel emerges as a promising strategy, improving clinical outcomes across a wide range of patients.
This prospective, double-blind controlled trial was conducted to determine the effect of silicone gel in the reduction of postoperative scar after bilateral inguinal varicocelectomy. Thirty-four patients were enrolled in this study; the right-side inguinal scar was treated with silicone gel and petroleum jelly (Vaseline) applied on the left side as a placebo for 60 consecutive days. Scars were evaluated using the Vancouver Scar Scale, pruritus and pain. The result of this study showed that silicone gel was effective in the regression of postoperative scar after microscopic inguinal varicocelectomy in five key parameters, including vascularity, pigmentation, pliability, height and pruritus in comparison to placebo application (p < 0.05), while its effect on pain was insignificant (p > 0.05). The study showed that silicone gel had a considerable effect in the treatment and management of postoperative scar management. Varicocele is a condition that is considered the most common cause of male infertility. While microscopic inguinal varicocelectomy is considered a gold standard in the management of varicocele, its postoperative complications, such as scar formation remain a concern. Recent studies show that silicone gel can be an effective non-invasive treatment for scar regression. Accordingly, we designed this trial to evaluate the effect of silicone gel after microscopic inguinal surgery. A prospective double-blind controlled trial was conducted on 34 patients who had microscopic bilateral inguinal varicocelectomy (their age ranged from 19 to 41) at Namazi hospital. Two weeks after surgery, each patient received two identical tubes for application on the scars, the first tube containing silicone gel and the second one dispensed with petroleum jelly (Vaseline). The right side was treated with silicone gel, and the left side with Vaseline twice daily for 60 days. Then, patients were evaluated three times: firstly 2 weeks after surgical repair; second appointment after 2 months and third one after 6 months after surgery, using the Vancouver Scar Scale, pruritus and pain score. The collected data were analysed in SPSS 26, using the chi-square and Mann–Whitney U tests. The significance level was defined at p < 0.05. This study showed that silicone gel was highly effective in scar parameters, including pliability, height, vascularity pruritic and pigmentation. However, its effect on pain reduction was not significant (p > 0.05). The results of the study indicated that silicone gel effectively improved scar characteristics following microscopic inguinal varicocelectomy, while its efficacy against pain was not significant.
This study aimed to gain clinician consensus on which signs/symptoms reported to be indicative of biofilm in chronic wounds are likely to be so. An international, two-round eDelphi process including wound care clinicians ran from December 2023 to February 2024. Participants rated 26 items on a 9-point Likert scale. Consensus to include: ≥ 70% of respondents rate an item 7–9, ≤ 15% rate it 1–3. Consensus to exclude: ≥ 70% of respondents rate an item 1–3, ≤ 15% rate it 7–9. Eleven items (visual indicators [a shiny, slimy, persistent layer, easily removed, returns quickly without frequent intervention]; failure to respond to antimicrobials; infection > 30 days duration; poor quality granulation tissue; stalled wound despite optimal management; persistent/prolonged inflammation; wound > 6 weeks duration; soft tissue deterioration despite antimicrobials/debridement; signs of local infection; tunnelling/undermining; presence of slough) achieved consensus to include status. To our knowledge, consensus work on this topic has not previously been performed on such a wide scale. When examined alongside similar work, clinical opinion on the matter lacks coherence. We hope that these findings will help direct us toward greater cohesiveness. The work supports a need for research to quantify the predictive abilities of signs and symptoms reported to be indicative of biofilm in chronic wounds.
In England, diabetes-related foot ulcers and related amputations equate to approximately 1% of the National Health Service budget. Most of these costs are related to hospital admissions with diabetes-related foot ulcers, found to be 8.04 days longer when compared to those without ulcers. Although South Asian (SA) populations living in Western countries experience disproportionately high diabetes rates, they exhibit significantly lower prevalence of diabetes-related foot ulcers and lower-limb amputations compared to White European populations. This paradox remains underexplored, necessitating a scoping review to map existing evidence, elucidate disparities, and identify gaps. To explore the burden of diabetes-related foot ulcers among South Asians living in Western countries by examining their incidence, prevalence, and predisposing factors. Assessing clinical outcomes and lived experiences during the ulcerative phase and reviewing existing literature on recurrence and long-term post-healing complications. Following Joanna Briggs Institute methodology and reported in line preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews. A comprehensive search will be conducted across databases, and registered with open science framework. This will be the first scoping review to map diabetes-related foot ulcers burden among South Asians in Western settings. Clarifying incidence and outcome disparities, highlighting research gaps, and suggesting directions for future studies.
Complex reconstructions are often required after head and neck tumour resections, particularly in irradiated fields and areas with exposed bone. Fish skin grafts (FSG) have recently emerged as a potential adjunct in difficult wound healing. This case report series evaluates the effectiveness of FSG in combination with octenidine-based antiseptics, which have already shown beneficial results in split-thickness skin transplantation in high-risk patients, focusing on the time period for granulation and wound closure. Five patients with seven defects of different aetiology in the head and neck region received FSG applications. Defect sizes ranged from 2 × 4 cm (occipital) to 7 × 6 cm (temporal). Granulation was determined, with irradiated and non-irradiated wounds analysed separately. In three consecutive cases, octenilin gel (octenidine-based hydrogel) was implemented in the treatment regimen. Three patients achieved complete granulation, while two reached 66%–80% granulation. Non-irradiated wounds demonstrated faster granulation (mean 16.5 days) compared to irradiated wounds (mean 48.8 days). Although there was no statistical significance, a trend toward delayed healing in irradiated tissue was observed. Patients treated with octenilin gel showed favourable healing outcomes, including shorter granulation times. Despite the poor prognosis for uncomplicated healing in this cohort, both treatment protocols—octenisept with Flaminal forte and octenisept with octenilin gel—achieved satisfactory outcomes when combined with FSG transplantation. This approach appears promising for reconstruction in challenging head and neck wounds and warrants further evaluation in prospective clinical studies.
Surgical Site Infections (SSIs) are common causes of readmission after spine surgery; however, not all postoperative wound issues are SSIs. This study introduces the concept of “Wound Healing Problem (WHP)” as a distinct condition. A retrospective analysis was conducted on 26 patients who underwent spinal fusion surgery between 2017 and 2018. Although these patients were discharged in good health, they presented with wound-related problems an average of 11 days post-surgery. Initial assessments suggested SSIs, but further evaluation indicated a separate pathology: WHP. WHP was observed an average of 10.62 ± 1.81 days after surgery, with significant variations in recovery times among patients. While WHP differs from SSIs, it is commonly managed with initial SSI protocols. This article aims to introduce WHP as a new concept, setting a foundation for further studies.
This study retrospectively reviewed 46 patients undergoing transmetatarsal amputation (TMA) between January 2017 and January 2023 to evaluate complication rates within 6 months and assess the predictive value of the SINBAD classification for re-amputation risk. Patients were categorised based on re-amputation occurrence, and clinical and demographic data were collected. Each case was evaluated using the SINBAD scoring system, with logistic regression used to assess associations. Among the patients, 28 (60.9%) experienced no re-amputation, while 18 (39.1%) underwent re-amputation. Baseline demographics and laboratory findings did not significantly differ between groups. The mean SINBAD score was significantly higher in the re-amputation group (3.67 vs. 2.29; p < 0.001), with logistic regression identifying SINBAD score as an independent predictor (OR 6.76; 95% CI: 2.18–21.02; p < 0.001). A SINBAD score of ≥ 4 was associated with a re-amputation rate of 90.9%. In conclusion, the SINBAD classification proves to be a simple and effective tool for predicting re-amputation post-TMA, facilitating risk stratification and surgical planning for diabetic foot ulcer patients.
This study aimed to determine the level of knowledge of nurses caring for inpatients about medical device-related pressure injuries (MDRPI). This descriptive and cross-sectional study was conducted in a city hospital. A self-reporting survey was provided to a sample of 217 nurses. The research data were collected using the ‘Personal Information Form’ to assess the independent variables and the ‘MDRPI Knowledge Questionnaire’ to measure the dependent variable, which is the nurses' knowledge level regarding MDRPI. The mean total score of the MDRPI knowledge questionnaire of the participant nurses was found to be 12.82 ± 2.99 on a scale from 0 to 25. In the study, a statistically significant difference was found between the educational level and the clinic where the nurses worked and the mean scores of the questionnaire (p < 0.05). When examining the correct responses given by nurses to the survey items assessing their knowledge of MDRPIs, the highest correct response rate was 94.9% for the statement “The appropriate medical device with the right size should be chosen for the patient to avoid MDRPIs,” whilst the statement with the lowest correct response rate, at 6.5%, was “To avoid the occurrence of MDRPIs, the skin under and around the medical device should be checked at least once a day.” As a result, it was found that nurses' knowledge level about MDRPI was moderate.
Hypertrophic scars (HTSs) result from excessive collagen accumulation and impaired wound remodelling, leading to considerable aesthetic and functional concerns. Despite the availability of various treatment strategies, their clinical success remains limited, emphasising the need for alternative approaches. Human amniotic fluid (hAF), naturally enriched with cytokines and growth factors, has emerged as a promising biological material for tissue regeneration. This study investigated the therapeutic potential of two forms of hAF—pooled-frozen and pooled-frozen gamma-irradiated—in a rat model of hypertrophic scarring. Fifteen adult male Sprague–Dawley rats were randomly assigned to receive subcutaneous injections of either saline, pooled-frozen hAF, or pooled-frozen gamma-irradiated hAF at the wound margins on days 1, 3 and 5 following the induction of hypertrophic scars via talc powder application. After 21 days, wound healing was evaluated through histological and immunohistochemical analyses. Both treatment groups demonstrated significantly improved wound healing compared to the control group. Granulation tissue formation was enhanced in the treated groups, particularly in animals receiving gamma-irradiated fluid, which also showed superior collagen remodelling characterised by aligned and mature collagen bundles. Both treatment groups demonstrated an increase in M2 macrophage density, as evidenced by elevated Arg+/CD68+ cell ratios; however, this effect was more pronounced in the gamma-irradiated group, indicating a stronger shift towards a regenerative immune profile. Enhanced reepithelialisation, increased hair follicle density and reduced scar thickness were also observed. These findings suggest that gamma-irradiated hAF provides a more effective and minimally invasive therapeutic option for modulating scar formation and improving wound healing outcomes, supporting its potential translation into clinical applications for the management of hypertrophic scars.
Surgical site infections (SSI) and surgical site complications (SSC) significantly impact surgery outcomes, increasing hospital stays and mortality rates, and negatively affecting patients' quality of life. Closed-incision negative pressure therapy (ciNPT) emerged as a prophylactic strategy to reduce these complications. However, its applicability across different surgical procedures remains unclear. A scoping review was conducted to synthesise the available evidence on the use of ciNPT in different surgical contexts. A multidisciplinary panel of experts from different surgical specialties was assembled to identify patient risk factors for SSCs specific to each modality. Surgical procedures were categorised based on anticipated SSC rates and the impact of SSI. A decision diagram was finally developed, providing tailored recommendations for ciNPT use according to individual surgical circumstances. The findings of the review indicate that ciNPT effectively reduces SSI and SSC in most surgical procedures. Key patient-related factors influencing outcomes, such as age, obesity, and malnutrition, were outlined. Additionally, a specialty-based list of surgical procedures was compiled, specifying whether ciNPT is recommended, not recommended, or conditionally recommended based on specific criteria. This study underscores the benefits of ciNPT and provides a comprehensive guide to its application across several surgical specialties, aiming to optimise patient management and inform clinical practise.
Soft silicone multi-layer dressings are commonly used for pressure ulcer (pressure injury) prevention, yet their effectiveness varies based on design, construct, and material properties. This study evaluated the protective efficacy of a new multi-layer dressing, ALLEVYN COMPLETE CARE (ACC, Smith & Nephew Limited), which incorporates an advanced structure facilitating the dissipation of shear forces through internal layer-on-layer frictional sliding within the dressing. Using a combination of experimental frictional energy absorber effectiveness (FEAE) testing and computational finite element modelling, we quantified the capacity of this dressing to mitigate strain and stress concentrations in the soft tissues of the supported posterior heel. The dressing demonstrated considerable frictional sliding between its adjacent layers, resulting in FEAE = 93% under simulated, clinically relevant usage conditions. This was associated with the dissipation of shear forces and alleviation of strain/stress concentrations in the skin and underlying soft tissues below the dressing. The dressing completely eliminated the stress and strain peaks at the top quartiles of the strain/stress domain (with reference to a no-dressing case). This work provided valuable insights into advanced testing methods and beneficial design principles for pressure ulcer prevention dressings. Earlier investigations concluded that a previous-generation ALLEVYN LIFE dressing achieved high levels of FEAE and thus provided protection. Our findings here establish that the next-generation dressing, ACC, demonstrates even greater protective capacity.
Limited evidence exists regarding the effectiveness of learning approaches in supporting interprofessional wound care education transnationally. The aim of this pilot study was to explore the feasibility and preliminary impact of an international, online interprofessional masterclass in supporting baccalaureate health students' learning about wound care. Data were collected using multiple methods including quantitative survey, qualitative focus groups, and interviews with baccalaureate nursing, pharmacy, dietetics, podiatry and paramedicine students from two universities based in Australia and Northern Ireland. A retrospective pre-test design was used. A survey retrospectively assessed students' self-reported confidence and understanding before and after the masterclass, while qualitative methods explored students' experiences of interprofessional learning and wound care. Self-reported improvements in students' understanding of wound assessment and management, as well as heightened awareness of interprofessional contributions to patient care indicated the potential value of this interprofessional and international collaboration in supporting wound care education. Qualitative analysis identified four themes: recognising a wound is a person's wound; comparing international healthcare practices; fostering learner engagement; interprofessional recognition, acknowledgment, and understanding of each profession's roles, contributions and expertise. This pilot study has highlighted key issues to be addressed in future research examining the impact of a collaborative online international initiative on baccalaureate students' interprofessional learning about wound care.
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