OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications.
METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling.
RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).
CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.
Patients and methods: This single-blind, prospective, randomized-controlled study included a total of 20 patients (8 males, 12 females; mean age: 53.5±13.8; range, 31 to 82 years) with chronic neuropathic pain between January 2014 and June 2014. The patients were randomized to BEST (n=10) or placebo (n=10) group. Pain was measured using the Visual Analog Scale, and serum cortisol levels were measured before and after treatment.
Results: There was no significant difference in the baseline demographics, diagnosis, and treatment modalities between the groups. Approximately 50% patients in the treatment group reported that the treatment was effective, compared to 30% in the placebo group. Pain score reduction after treatment in the BEST group was significant (p<0.05), while it was not significant in the placebo group (p=0.4). Cortisol levels significantly reduced only in the BEST group after treatment (p=0.013).
Conclusion: The BEST yields reduction in pain severity and cortisol levels. Based on these results, it seems to be effective in the treatment of chronic neuropathic pain after a single treatment and may be more effective for long-term management.
METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.
METHODS: Sixty-six (66) patients with unilateral uncomplicated inguinal hernia were randomized into 34 patients in the tacker and 32 patients in cyanoacrylate glue mesh fixation in TEP repair. The extent of surgical trauma was evaluated by measuring inflammatory markers of C-reactive protein, white blood cell count at 48 h, and ESR at 3 months postoperatively. Postoperative acute and chronic pain was assessed by recording the visual analogue scale scores and surgical complications were recorded over 3 months of the study period.
RESULTS: The median CRP and WBC levels at postoperative 48 h in both groups raised significantly from the baseline values (p 0.05). The median ESR level increased significantly at 3 months postoperatively from baseline in the glue mesh fixation group only (p 0.05). There was no significant difference for VAS scores at all timelines between the tacker and glue mesh fixation group (p > 0.05).
CONCLUSION: Cyanoacrylate glue mesh fixation technique as an alternative method to mechanical fixation in TEP repair is comparable to tacker and can be considered to be safe and feasible.
METHODS: This was a single-center, prospective, and single-blind randomized controlled trial conducted at the University Malaya Medical Centre. Patients older than 65 years presenting to the hospital emergency department or geriatric clinic with 1 injurious fall or 2 falls in the past year and with impaired functional mobility were included in the study. The intervention group received a modified OEP intervention (n = 34) for 3 months, while the control group received conventional care (n = 33). All participants were assessed at baseline and 6 months.
RESULTS: Twenty-four participants in both OEP and control groups completed the 6-month follow-up assessments. Within-group analyses revealed no difference in grip strength in the OEP group (P = 1.00, right hand; P = .55, left hand), with significant deterioration in grip strength in the control group (P = .01, right hand; P = .005, left hand). Change in grip strength over 6 months significantly favored the OEP group (P = .047, right hand; P = .004, left hand). Significant improvements were also observed in mobility and balance in the OEP group.
CONCLUSIONS: In addition to benefits in mobility and balance, the OEP also prevents deterioration in upper limb strength. Additional benefits of exercise interventions for secondary prevention of falls in term of sarcopenia and frailty should also be evaluated in the future.
METHODS: 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores.
RESULTS: Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09).
CONCLUSIONS: Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.
METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year.
RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction.
CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
METHODS: This was a prospective, randomised controlled trial. We recruited diabetic patients aged > 18 years, American Society of Anesthesiologists class II-III, who were scheduled for unilateral diabetic foot surgery below the knee. All patients were assessed for autonomic dysfunction using the Survey of Autonomic Symptoms score. Participants were randomly assigned to receive either PNB or SAB for the surgery. Hemodynamic data, including usage of vasopressors, were recorded at 5-min intervals for up to 1 h after the induction of anesthesia. Pain scores were recorded postoperatively, and follow-up was done via telephone 6 months later.
RESULTS: Compared to the PNB group, the SAB group had a larger number of patients with significant hypotension (14 vs. 1; p = 0.001) and more patients who required vasopressor boluses (6 vs. 0 patients). Compared to SAB group, the patients in the PNB group had a longer postoperative pain-free duration (9 vs. 4.54 h; p = 0.002) and lower pain scores 1 day after surgery (3.63 vs. 4.69; p = 0.01).
CONCLUSION: Peripheral nerve block should be considered, whenever possible, as the first option of anesthesia for lower limb surgery in diabetic patients as it provides hemodynamic stability and superior postoperative pain control compared to SAB.
TRIAL REGISTRATION: Clinical trial registry: ClinicalTrials.gov. ID NCT02727348.
Subjects and Methods: Two groups of 40 patients each having dentinal hypersensitivity were treated using 8% proarginine and iontophoresis. The patients were recalled after 1, 2, and 4 weeks. The scores were tabulated and the results were analyzed using SPSS statistical software.
Results: Visual analog scale between the two groups showed a significant difference from the 1st week till the 4th week. ANOVA values showed the reduction in the dentinal hypersensitivity in Group 2 using the iontophoresis along with the 8.0% arginine-calcium carbonate toothpaste. The Cochran-Mantel-Haenszel correlation test of the Schiff's dentinal hypersensitivity cross-tabulation showed P < 0.001 which was statistically significant reduction after the 4th week following the application of 8.0% arginine-calcium carbonate along with iontophoresis.
Conclusion: Iontophoresis, when used along with Colgate® Sensitive Pro-Relief™ toothpaste, can provide additional benefit as this provides a better sealing effect.
METHODS: A participant blinded, multi-centre, randomised controlled trial was conducted in which the participants in the intervention group (IG) practiced deep breathing exercise guided by sound cues and those in the control group (CG) listened to the music. The primary end point was reduction in blood pressure at eight weeks.
RESULTS: 87 patients, 46 males and 41 females with mean age of 61.1 years were recruited and 93.1% of them successfully completed the study. There was significant reduction in systolic and diastolic Blood Pressure from baseline by 8 weeks in both groups. The reduction in Mean systolic blood pressure (SBP) in the control arm was 10.5mmHg compared to 8.3mmHg (p<0.001) in intervention group. Diastolic blood pressure (DBP) reduction in control and intervention groups were 5.2 mmHg (p<0.001) and 5.6 mmHg (p<0.001) respectively. The absolute difference in SBP reduction from baseline in IG & CG was -2.2 (95%CI: -7.8 to 3.5) and DBP was -0.4 (95%CI: -2.9 to 3.6). However, blood pressure reduction between the two groups was not significant.
CONCLUSIONS: Both listening to music and deep breathing exercise were associated with a clinically significant reduction in SBP and DBP. However, deep breathing exercise did not augment the benefit of music in reducing BP.