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Venous leg ulcers (VLUs) are traditionally managed with standard-of-care dressings, compression and appropriate adjunctive venous interventions for pathologic venous reflux. Due to pathophysiological complexity and underlying patient comorbidities, conducting randomised controlled trials to evaluate the comparative efficacy of advanced treatment modalities is difficult, as many patients would likely be excluded. This retrospective, pragmatic, real-world evidence (RWE) study compared the healing outcomes of VLUs treated with either ovine forestomach matrix (OFM) (n = 312) or collagen/oxidised regenerated cellulose (ORC) (n = 239) in outpatient wound care centres. Unlike restrictive randomised controlled trials, minimal inclusion and exclusion criteria were applied to create two treatment cohorts that reflected the general VLU population. The incidence (%) of closure was greater in OFM-treated VLUs at 12, 24 and 36 weeks, and this difference was significant at 24 and 36 weeks compared to collagen/ORC. Median time to wound closure was significantly faster (p = 0.045) in the OFM cohort (11.1 ± 0.6 weeks) compared to the collagen/ORC group (12.3 ± 1.0 weeks). Cox proportional hazards analysis demonstrated that OFM-treated VLUs had a significantly greater probability of healing (up to ~40%). This RWE comparative efficacy study further substantiates the clinical benefit of OFM in the treatment of chronic wounds, such as VLU, in a real-world patient cohort.
Trauma and orthopaedic surgery (TOS) can result in surgical site infections (SSIs), and the repercussions include prolonged and increased cost of treatment. This study investigated the incidence and risk factors of SSI following TOS. A prospective cohort study was conducted at the Tamale Teaching Hospital from September 2023 to May 2024. Data on demographics, comorbidities, preoperative, intra-operative and postoperative parameters were collected from patients, medical records and the operation report. SSI was defined following the Centers for Disease Control and Prevention criteria. The incidence of SSI during the study period was determined, and univariate and multivariate logistic regression analyses were used to identify the independent risk factors of SSI. A total of 210 patients were enrolled of which 6.7% (14) developed SSIs, including 1.0% (2) deep and 5.7% (12) superficial SSIs. The incidence of open fractures and closed fractures in this study was 3.3% (7) and 2.9% (6), respectively. According to multivariate regression analysis, blood transfusion before surgery (p = 0.034; OR = 3.53; 1.10–11.33) was identified as an independent risk factor of SSI following TOS. However, there was a significant association between the type of dressing used on the surgical site after surgery (p = 0.035; OR = 4.08; 1.10–15.08) and SSI. The study reported the overall incidence rate of SSI after TOS to be 6.7% (67 per 1000 surgical operations). Blood transfusion before surgery was an independent risk factor of SSI following TOS. Local and global measures that limit the rates of SSI after TOS should be adopted especially in managing high-risk patients such as those who require pre-operative blood transfusion.
Coronary artery disease (CAD) is a common problem amongst diabetic foot syndrome (DFS) patients, associated with peripheral arterial disease. This analytic cross-sectional study investigates the diagnostic efficacy of the Toe Brachial Index (TBI) in the detection of CAD in 62 DFS patients. The presence of CAD was assessed by longitudinal strain echocardiography, a sensitive method that provides a more accurate measure of intrinsic left ventricular contractility than left ventricular ejection fraction, especially in diabetic patients. Univariate and multivariate logistic regression identified CAD-associated factors. Receiver operating characteristic curve evaluated TBI and toe pressure's diagnostic performance for CAD. p-Values < 0.05 were considered significant. There was a significant association between TBI and CAD, with each 0.01 increase in TBI associated with a 15% decrease in the odds of CAD development (odds ratio = 0.85, 95% CI: 0.72–0.99, p = 0.039). TBI demonstrated an area under the curve of 0.854, a sensitivity of 80.0% and a specificity of 66.7% at a cut-off of 0.69. Additionally, toe pressure exhibited an area under the curve of 0.845, sensitivity of 74.0% and specificity of 75.0% at a cut-off of 68.0 mmHg. Overall accuracy for TBI and toe pressure was 77.4% and 74.2%, respectively, indicating their potential for CAD risk stratification in the DFS population. This study highlights a significant association between low TBI and the presence of CAD in DFS patients. Consequently, TBI emerges as a valuable screening tool for identifying CAD within this population.
For assessing health-related quality of life in patients with chronic wounds, the Wound-QoL questionnaire has been developed. Two different versions exist: the Wound-QoL-17 and the Wound-QoL-14. For international and cross-cultural comparisons, it is necessary to demonstrate psychometric properties in an international study. Therefore, the aim of this study was to test both questionnaires in a European sample, using item response theory (IRT). Participants were recruited in eight European countries. Item characteristic curves (ICC), item information curves (IIC) and differential item functioning (DIF) were calculated. In both questionnaires, ICCs for most items were well-ordered and sufficiently distinct. For items, in which adjacent response categories were not sufficiently distinct, response options were merged. IICs showed that items on sleep and on pain, on worries as well as on day-to-day and leisure activities had considerably high informational value. In the Wound-QoL-14, the item on social activities showed DIFs regarding the country and age. The same applied for the Wound-QoL-17, in which also the item on stairs showed DIFs regarding age. Our study showed comparable results across both versions of the Wound-QoL. We established a new scoring method, which could be applied in international research projects. For clinical practice, the original scoring can be maintained.
The Wound-QoL assesses the impact of chronic wounds on patients' health-related quality of life (HRQoL). A 17-item and a shortened 14-item version are available. The Wound-QoL-17 has been validated for multiple languages. For the Wound-QoL-14, psychometric properties beyond internal consistency were lacking. We aimed to validate both Wound-QoL versions for international samples representing a broad range of European countries, including countries for which validation data had yet been pending. Patients with chronic wounds of any aetiology or location were recruited in Austria, Lithuania, the Netherlands, Poland, Slovakia, Spain, Switzerland and Ukraine. Psychometric properties were determined for both Wound-QoL versions for the overall sample and, if feasible, country-wise. We included 305 patients (age 68.5 years; 52.8% males). Internal consistency was high in both Wound-QoL-17 (Cronbach's α: 0.820–0.933) and Wound-QoL-14 (0.779–0.925). Test–retest reliability was moderate to good (intraclass correlation coefficient: 0.618–0.808). For Wound-QoL-17 and Wound-QoL-14, convergent validity analyses showed highest correlations with global HRQoL rating (r = 0.765; r = 0.751) and DLQI total score (r = 0.684; r = 0.681). Regarding clinical data, correlations were largest with odour (r = −0.371; r = −0.388) and wound size (r = 0.381; r = 0.383). Country-wise results were similar. Both Wound-QoL versions are valid to assess HRQoL of patients with chronic wounds. Due to its psychometric properties and brevity, the Wound-QoL-14 might be preferrable in clinical practice where time is rare. The availability of various language versions allows for the use of this questionnaire in international studies and in clinical practice when foreign language patients are being treated.
In 2012 the European Medicines Agency approved a pineapple stem-derived Bromelain-based debridement concentrate of proteolytic enzymes (NexoBrid®, MediWound Ltd, Yavne, Israel) for adult deep burns. Over 10 000 patients have been successfully treated with NexoBrid® globally, including in the US. The aim of our study is to perform a systematic review of the current literature on Nexobrid® outcomes. We conducted a literature search in PubMed, Google Scholar, Embase, and other search engines (2013–2023). The online screening process was performed by two independent reviewers with the Covidence tool. The protocol was reported using the Preferred Reporting Items for Systematic Review and Meta-Analyses, and it was registered at the International Prospective Register of Systematic Reviews of the National Institute for Health Research. We identified 103 relevant studies of which 34 were found eligible. The included studies report the positive effects of Nexobrid® on burn debridement, functional and cosmetic outcomes, scarring, and quality of life. Also, they validate the high patient satisfaction thanks to enhanced protocols of analgosedation and/or locoregional anaesthesia during Bromelain-based debridement. Two studies investigate potential risks (coagulopathy, burn wound infection) which concluded there is no strong evidence of these adverse events. NexoBrid® is a safe, selective, non-surgical eschar removal treatment modality. The benefits of Bromelain-based debridement are faster debridement and healing times, reduced operations, length of stay, cases of sepsis, blood transfusions, and prevention of compartment syndrome. Existing evidence suggests that the indications and the role of Bromelain-based debridement are expanding to cover “off-label” cases with significant benefits to the global healthcare economy.
Chronic wounds can severely limit patient's social life. This cross-sectional study investigated quantitatively social support of patients with chronic wounds, its association with health-related quality of life as well as qualitatively changes in social participation of these patients. Overall, 263 patients from seven countries participated. The most frequent wound class was leg ulcer (49.2%). Results revealed generally high levels of social support (mean global score: 5.5) as measured with the Multidimensional Scale of Perceived Social Support. However, individuals differed considerably (range 1.0–7.0). All dimensions of social support differed by patients' family and living situations (p < 0.001 to p = 0.040) and were positively correlated with generic health-related quality of life (r = 0.136–0.172). Having children, living with others and being in a relationship were significant predictors of having higher global social support. Patients reported great support from family members. Many participants reported no changes in relationships with friends. Wound care managers took an important role and provided additional emotional support. Patients reported a range of discontinued activities. Despite the high overall level of social support, inter-individual differences should be acknowledged. The importance of family carers should be acknowledged to be able to reduce caregiver burden and to ensure high-qualitative wound care.
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