Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study.

PURPOSE: To evaluate the safety and efficacy of an at-home photobiomodulation (PBM) device for the treatment of diabetic foot ulcers (DFUs) in a frail population with severe comorbidities. METHODS: Prospective, randomized, double-blind, sham-controlled pilot study. Patients (age = 63 ± 11 years, male:female 13:7) with insulin-dependent diabetes type 2, neuropathy, peripheral artery disease, significant co-morbidities, and large osteomyelitis-associated DFUs (University of Texas grade ≥ III) were randomized to receive active (n = 10) or sham (n = 10) at-home daily PBM treatments (pulsed near-infrared 808 nm Ga-Al-As laser, 250 mW, 8.8 J/cm2) for up to 12 weeks in addition to standard care. The primary outcome was the %wound size reduction. The secondary was adverse events. RESULTS: With the numbers available, PBM-treated group had significantly greater %reduction compared to sham (area [cm2], baseline vs endpoint: PBM 10[20.3] cm2 vs 0.2[2.4] cm2; sham, 7.9 [12.0] cm2 vs 4.6 [13.8] cm2, p = 0.018 by Mann-Whitney U test). Wound closure > 90% occurred in 7 of 10 PBM-treated patients but in only 1 of 10 sham patients (p = 0.006). No adverse device effects were observed. CONCLUSIONS: Photobiomodulation at home, in addition to standard care, may be effective for the treatment of severe DFUs in frail patients with co-morbidities and is particularly relevant at these times of social distancing. Our preliminary results justify the conduction of a larger clinical trial. CLINICALTRIALS: gov: NCT01493895.

Body image and scar assessment: A longitudinal cohort analysis of cardiothoracic, neurosurgery and urology patients.

BACKGROUND: Scar severity and scar viewing are known to affect body image. The literature is lacking on the relationship between body image and surgical scar assessment. The aims of this study were to compare patients from 3 different surgical departments in terms of body image and scar assessment at discharge, in comparison with nurses' scar assessment, and 3 months post-surgery. In addition, the research examined age and gender in relation to the main variables. METHODS: A longitudinal, comparative, correlational study was conducted using an instrument which included a health history, a nurses scar assessment tool and a patient scar assessment tool at hospital discharge, as well as a body image tool used both at discharge and at 3 months' post-surgery. The 10-item body image scale was comprised of affective items, behavioural items and cognitive items. The STROCSS 2019 checklist is used. RESULTS: 75 patients were studied who were mostly male (68.0%) with a mean age of 59 and married (77.3%). The sample distribution of departments included 30.7% cardiothoracic, 29.3% neurosurgery and 40% urology. Cardiothoracic patients displayed a significant negative body image pre-surgery compared to post-surgery. Neurosurgical patients' scar assessments were significantly higher than nurses' assessments with no differences found in the other departments. CONCLUSIONS: The healthcare team needs to consider engaging patients in post-surgery discussions concerning scarring and body image. The results of this study revealed that expectations in both clinician and patient participants need to be assessed and evaluated for congruency in order to offer a greater patient-focused peri-operative experience.

Improved sensitivity, safety, and rapidity of COVID-19 tests by replacing viral storage solution with lysis buffer.

Conducting numerous, rapid, and reliable PCR tests for SARS-CoV-2 is essential for our ability to monitor and control the current COVID-19 pandemic. Here, we tested the sensitivity and efficiency of SARS-CoV-2 detection in clinical samples collected directly into a mix of lysis buffer and RNA preservative, thus inactivating the virus immediately after sampling. We tested 79 COVID-19 patients and 20 healthy controls. We collected two samples (nasopharyngeal swabs) from each participant: one swab was inserted into a test tube with Viral Transport Medium (VTM), following the standard guideline used as the recommended method for sample collection; the other swab was inserted into a lysis buffer supplemented with nucleic acid stabilization mix (coined NSLB). We found that RT-qPCR tests of patients were significantly more sensitive with NSLB sampling, reaching detection threshold 2.1±0.6 (Mean±SE) PCR cycles earlier then VTM samples from the same patient. We show that this improvement is most likely since NSLB samples are not diluted in lysis buffer before RNA extraction. Re-extracting RNA from NSLB samples after 72 hours at room temperature did not affect the sensitivity of detection, demonstrating that NSLB allows for long periods of sample preservation without special cooling equipment. We also show that swirling the swab in NSLB and discarding it did not reduce sensitivity compared to retaining the swab in the tube, thus allowing improved automation of COVID-19 tests. Overall, we show that using NSLB instead of VTM can improve the sensitivity, safety, and rapidity of COVID-19 tests at a time most needed.

Does Retrograde Treatment of Upper Urinary Tract Stones Necessitate Postoperative Upper Urinary Tract Drainage? Conclusions from More Than 500 Single Center Consecutive Cases.

BACKGROUND AND PURPOSE: Temporary drainage of the upper urinary tract after ureterorenoscopy for the treatment of urinary stones is almost a routine in endourologic practice. In these cases, a Double-J stent (DJS) is left for 7 or more days. In borderline cases, a ureteral catheter attached to the urethral catheter may be left for 24-48 hours. In some situations, tubeless approach is possible. The purpose of this study was to evaluate the necessity and immediate postoperative implications of upper tract drainage by comparing complications and symptoms at the immediate postoperative period in these three groups of patients. MATERIALS AND METHODS: A database of 516 consecutive patients who underwent ureterorenoscopy for ureteral and/or renal stones between October 2014 and September 2016 was retrospectively evaluated. The cohort was divided according to postoperative drainage type of the upper urinary tract. The data consisted of demographic parameters, stone location, number and burden, severity of preoperative obstruction, and postoperative complications. Symptoms at the immediate postoperative period, assessed by visual analog scale (VAS) score, frequency, and type of analgesics used, were evaluated and compared. Categorical dependent variables were evaluated using chi-square or Spearman's correlation tests, whereas continuous dependent variables were analyzed using Pearson correlation analysis. RESULTS: There were 196 (38%) tubeless, 214 (41%) UC, and 106 (21%) DJS cases. Patients who were drained with DJS at the end of the procedure were significantly with higher stone volume (p < 0.005), higher stone density (p < 0.005), and with more severe preoperative obstruction (p < 0.005). Postoperative complications (infection, stone-street, and acute renal failure), mean VAS score, or analgesics used were not different in the three subgroups. CONCLUSIONS: A tubeless approach is safe in properly selected cases. There is no difference in postoperative course compared with drained groups. Tubeless procedures may facilitate an outpatient approach for treatment of upper urinary tract stones.