Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16–2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.
Objective: Optimal wound-bed preparation consists of regular debridement to remove devitalised tissues, reduce bacterial load, and to establish an environment that promotes healing. However, lack of diagnostic information at point-of-care limits effectiveness of debridement. Method: This observational case series investigated use of point-of-care fluorescence imaging to detect bacteria (loads >104CFU/g) and guide wound bed preparation. Lower extremity hard-to-heal wounds were imaged over a 12-week period for bacterial fluorescence and wound area. Results: A total of 11 wounds were included in the study. Bacterial fluorescence was present in 10 wounds and persisted, on average, for 3.7 weeks over the course of the study. The presence of red or cyan fluorescent signatures from bacteria correlated with an average increase in wound area of 6.5% per week, indicating stalled or delayed wound healing. Fluorescence imaging information assisted in determining the location and extent of wound debridement, and the selection of dressings and/or antimicrobials. Elimination of bacterial fluorescence signature with targeted debridement and other treatments correlated with an average reduction in wound area of 27.7% per week (p<0.05), indicative of a healing trajectory. Conclusion: These results demonstrate that use of fluorescence imaging as part of routine wound care enhances assessment and treatment selection, thus facilitating improved wound healing.
Objective: Punch biopsy is a simple and effective diagnostic technique used in hard-to-heal wound management. Histologic examination can rule out cancer in the wound bed or diagnose vasculitis in a hard-to-heal or suspicious ulcer. A biopsy can determine the level of bacteria in an ulcer when infection is suspected. Despite its use, health professionals practicing in wound clinics hesitate to perform punch biopsies. The reasons vary from the invasive nature of the procedure to a fear of complications. Methods: A multicentre clinical trial evaluated the addition of fluorescence imaging to clinical examination in determining bacterial burden in hard-to-heal wounds. The protocol required a 6mm punch biopsy of any area (up to three) suspected of having moderate-to-high bacteria levels either on clinical examination or fluorescence image. If clinical examination and fluorescence imaging both did not indicate bacteria, the health professional took a biopsy of the centre of the ulcer. The biopsies were performed under local anaesthesia after cleansing the ulcer bed with sterile normal saline. Haemostasis was achieved with direct pressure and the occasional topical clotting agent. All of the patients were followed for 30 days to monitor for adverse events. Results: A total of 350 patientis with wounds (diabetic foot ulcer n=138; venous leg ulcer n=106; pressure ulcer n=22; surgical site infection n=60; other n=24), enrolled by 20 investigators at 14 sites in the US, underwent a total of 412 punch biopsies. Haemostasis was achieved in all 412 biopsies. No biopsy sites required cautery or suture ligation to control bleeding. No subjects returned to the clinic secondary to bleeding. A patient developed an infection three days post-biopsy that could have been due to the punch biopsy. However, the patient was HIV-positive and the quantitative biopsy was positive for infection, biopsy bacterial load of 106 colony forming units (CFU)/g. Conclusion: This trial used a 6mm punch to obtain tissue for culture, histology and additional biomarker research. In daily wound care practice, a smaller 3mm punch suffices. Adverse events were rare despite the larger biopsy. Punch biopsies are a safe procedure for obtaining tissue for histologic or microbiologic analysis.
elevated serum phosphorus levels and directly targeting suppression of intact parathyroid hormone (iPTH) production remain targets. This study aimed to evaluate the efficacy and safety of etelcalcetide in the treatment of secondary hyperparathyroidism in adult patients with CKD undergoing dialysis Methods: Ovid database (PubMed, Embase, and Cochrane etc.) searched from inception to 8 th January 2020 for relevant trials. No language and date restrictions were imposed. Cochrane risk of bias assessment tool was used to assess the quality of randomized controlled trials (RCTs). Two review authors independently selected, extracted the data and assessed the quality of RCTs. All RCTs assessing the efficacy and safety of etelcalcetide in secondary hyperparathyroidism adult patients with CKD undergoing dialysis were included. All statistical analyses performed using R-software Results: Five RCTs including n=1887 patients were included in the review. The pooled analyses reported 30% reduction in iPTH in favor of etelcalcetide (Odds ratio [OR] 31.77, 95% Confidence interval [CI] 22.82 to 45.14, 3 RCTs), cinacalcet (OR 20.17, 95% CI 12.76 to 32.19, 1 RCT) when compared to placebo. Moreover, significantly less overall discontinuation observed with etelcalcetide than placebo (OR 0.54, 95% CI 0.39 to 0.73, 3 RCTs). However, etelcalcetide was associated with significantly more treatment-related adverse events compared to placebo (OR 6.48, 1.94 to 30.64, 1 RCT). No significant difference was observed in terms of death between etelcalcetide and placebo (OR 0.73, 95% CI 0.32 to 1.60, 1 RCT with 2 observations Conclusions: Etelcalcetide is associated with significantly more reduction in iPTH values, less overall discontinuation and with more treatment-related adverse event
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