Abstract

The present study aimed to compare the efficacies of intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA) following single needle arthrocentesis in patients with TMJ internal derangement. This double-blinded randomised controlled trial involved the enrolment of patients diagnosed with unilateral TMD, falling into either Wilkes' stages II or III. In Group A, single needle arthrocentesis was performed using Ringer's lactate serving as a control group; in Group B, intra-articular injection of 1 ml hyaluronic acid injection was given following arthrocentesis; and in Group C, autologous intraarticular injections of 1 ml of PRP was given after arthrocentesis, twice in two weeks' interval. The primary outcome variables were maximum mouth opening and pain, while TMJ clicking sounds formed the secondary outcome variable. All the outcome variables were assessed preoperatively (T0) and postoperatively after the second dose of injection at one month (T1), three months (T2), and six months (T3). The alpha level was set to p < 0.05. Ninety patients (N = 90) comprised the final sample size of the study with thirty patients(n = 30) in each treatment group. A statistically significant decrease in the management in mean pain scores was noted between T0 [mean scores were 7.30 ± 1.05 (Group A), 7.63 ± 1.12 (Group B), and 7.56 ± 1.04(Group C)] and T3 [mean scores were 2.66 ± 0.88 (Group A), 2.4 ± 0.72 (Group B), and 1.66 ± 0.66 (Group C)] time intervals between Group A and C(p < 0.001). Significant improvement was noted in preoperative maximum mouth opening (MMO) of Group A, B, and C which was 22.83 ± 3.58, 22.17 ± 4.07, and 21.37 ± 3.69, respectively to 28.90 ± 2.72, 32.17 ± 3.97, and 34.10 ± 3.80 mm, respectively at six months postoperatively (p < 0.001). A significant decrease in joint sounds was evident for all three groups(p = 0.003 for Group A, p < 0.001 for Group B, and p < 0.001 for Group C) across the time intervals. Moreover, Group C showed a significant decrease in the prevalence of joint sound compared to the other two groups at all-time intervals postoperatively when equated to baseline (p = 0.02 at T1, p = 0.009 at T2, and p = 0.002 at T3). Within the limitations of the present study, it can be concluded that intra-articular PRP may be preferable over HA whenever appropriate, following single needle arthrocentesis in the treatment of TMJ internal derangement.

Abstract

OBJECTIVE To evaluate a novel curriculum to enhance knowledge and preparedness of Emergency Medicine (EM) residents in the management of postpartum hemorrhage (PPH) METHODS A randomized controlled trial examined two pedagogical approaches. Following baseline testing of knowledge and confidence in PPH management, participants were randomized to receive a didactic lecture on PPH management (group A, n=14) or to the didactic lecture followed by simulation-based training on PPH management and debriefing (group B, n=16). Post-intervention, proficiency in PPH management was evaluated by clinical skills simulation and post-intervention assessment for participants. The change in the mean test and clinical skills scores were compared using student's t test. Linear regression examined the effects of covariates. RESULTS Both forms of intervention increased participants' knowledge (group A: mean=2.50 CI (1.63, 3.37), p<0.001; group B: mean=1.56 CI (0.89, 2.24), p<0.001) of and confidence (group A: mean=1.00 (0.46, 1.54),p=0.003; group B: mean=1.00 CI (0.52, 1.48),p=0.001) in PPH management, relative to baseline. However, addition of simulation and debriefing to didactic session did not offer any advantage (knowledge: mean=-0.94 CI (-1.97, 0.10), p=0.074; confidence: mean=0.00 CI (-0.66,0.66), p=1.000). CONCLUSION Delivery of a structured curriculum led to improvement of knowledge and confidence in the management of PPH by EM residents.

Abstract

INTRODUCTION This study aimed to evaluate the effect of platelet-rich plasma (PRP) on the rate of orthodontic tooth movement (OTM) during en-masse anterior retraction. METHODS Twenty adult patients with Angles Class I bimaxillary protrusion or crowding requiring first premolar extraction for routine orthodontic treatment were divided into control and experimental groups. The control group did not receive PRP, whereas the experimental group received PRP in the alveolar mucosa of the maxillary 6 anterior teeth just before starting en-masse retraction. Measurements were recorded on digital models made from scanned plaster casts at the beginning of space closure and the end of 3 months. The overall rate of OTM between both groups was compared. The amount of anchorage loss and type of anterior retraction on lateral cephalogram was also compared between the groups. RESULTS The overall rate of OTM was minimally increased but not statistically significant in the experimental vs control group (P = 0.838). Anterior retraction parameters in both groups showed incisors moving primarily by controlled tipping and partly by translation. An intergroup comparison of all cephalometric parameters for anchorage loss and anterior retraction showed statistically insignificant differences between both groups. CONCLUSIONS PRP is ineffective in accelerating the rate of OTM during en-masse anterior retraction.

Abstract

INTRODUCTION Iron deficiency anemia (IDA) in pregnancy has a prevalence as high as 40-60% in different countries of the world. Oral iron is used to treat his commonest medical disorder in pregnancy. Ferrous sulphate is associated with considerable side effects. Ferric carboxymaltose (FCM) is a newer iron preparation which allows for single and higher dose (up to 1000 mg) of IV iron infusion. This study was conducted to compare the efficacy of FCM and FS in treating IDA during pregnancy. METHODS A randomised control trial was done at a tertiary care centres involving 362 women (181 women each in FS and FCM group). The pregnant anemic women with IDA were enrolled between 18 and 34 weeks of pregnancy. They were given 1000 mg of FCM iv as single dose or were given FS tablets twice daily (120 mg iron daily). The data were collected for rise in the Hb and serum ferritin over a period of 6 weeks. RESULTS Nine and 18 patients were lost to follow-up in the FCM and FS group, respectively. The data were analysed as per protocol analysis. FCM group women showed 2.6 gm% rise in Hb compared to 1.7 gm% of FS group. One hundred and sixty-six out of 172 women in FS group achieved anemia correction at 6 weeks. No difference was observed in the neonatal outcome. No major side effects were observed in the either group. CONCLUSION In our study, FCM was more effective than oral FS in increasing Hb in women with IDA during pregnancy. This clinical benefit with FCM was achieved without the concerns for safety and tolerability of the drug.

Abstract

BACKGROUND Intravenous iron therapy can improve symptoms in patients with heart failure, anemia and iron deficiency. The mechanisms underlying such an improvement might involve chemoreflex sensing and nocturnal breathing patterns. METHODS Patients with heart failure, reduced left ventricular ejection fraction, anemia (hemoglobin <13 g/dL in men; <12 g/dL in women) and iron deficiency (ferritin <100 or 100-299 mcg/L with transferrin saturation <20%) were 2:1 randomized to patients-tailored intravenous ferric carboxymaltose dose or placebo. Chemoreflex sensitivity cardiorespiratory sleep study, symptom assessment and cardiopulmonary exercise test were performed before and two weeks after the last treatment dose. RESULTS Fifty-eight patients (38 active arm / 20 placebo arm) completed the study. Intravenous iron was associated with less severe symptoms, higher hemoglobin (12.5±1.4 vs. 11.7±1.0mg/dl p<0.05) and improved hematinic parameters. Ferric carboxymaltose improved the central hypercapnic ventilatory response (-25.8%, p<0.05 vs. placebo), without changes in peripheral chemosensitivity. In particular, the central hypercapnic ventilatory responses passed from 4.6±6.5 to 2.9±2.9 L/min/mmHg after ferric carboxymaltose and from 4.4±4.6 to 4.6±3.9 L/min/mmHg after placebo (p(treatment*condition) =0.046). In patients presenting with sleep-related breathing disorder, apnea-hypopnea index was reduced with active treatment as compared to placebo (12±11 vs. 19±13 events/h, p<0.05). After ferric carboxymaltose, but not after placebo, both peak oxygen uptake (VO2) increased (Δ1.1±2.0 mL/Kg/min, p<0.05) and VO2/workload slope was steeper (Δ0.67±1.7 L/min/W, p<0.01). CONCLUSIONS Intravenous ferric carboxymaltose improves the hypercapnic ventilatory response and sleep-related breathing disorders in patients with heart failure, anemia and iron deficiency. These newly described findings, along with improved oxygen delivery to exercising muscles, likely contribute to the favorable effects of ferric carboxymaltose in anemic patients with heart failure. This article is protected by copyright. All rights reserved.

Abstract

BACKGROUND The most commonly used topical haemostatic agents during flexible bronchoscopy (FB) are cold saline and adrenaline. Data on usage of other agents such as tranexamic acid (TXA) for this purpose are limited. RESEARCH QUESTION Is TXA effective and safe in controlling iatrogenic bleeding during FB compared to adrenaline? STUDY DESIGN AND METHODS We conducted a cluster-randomized, double blind, single centre trial in a tertiary teaching hospital. Patients were randomized in weekly clusters to receive up to 3 applications of TXA (100mg, 2ml) or adrenaline (0.2mg, 2ml, 1:10000) following haemostasis failure after 3 applications of cold saline (4°C, 5ml). Crossover was allowed (for up to 3 further applications) before proceeding with other interventions. Bleeding severity was graded by the bronchoscopist using a visual analogue scale (VAS; 1 - very mild, 10 - severe). RESULTS A total of 2033 FB were performed and 130 patients were successfully randomized to adrenaline (N=65) or TXA (N=65), while 12 had to be excluded for protocol violations (2 from the adrenaline and 10 from TXA arm). Bleeding was stopped in 83.1% (54/65) of patients in both groups (p=1). The severity of bleeding and number of applications needed for bleeding control (N) were similar in both groups (adrenaline mean VAS= 4.9±1.3, N=1.8±0.8; TXA mean VAS=5.3±1.4, N=1.8±0.8). Both adrenaline and TXA were more successful in controlling moderate (86.7% and 88.7%) than severe (40% and 58.3%) bleeding (p=0.008 and p=0.012, respectively), and required more applications for severe (3.0±0 and 2.4±0.5) than moderate (1.7±0.8 and 1.7±0.8) bleeding control (p=0.006 and p=0.002, respectively). We observed no drug related adverse events in both groups. INTERPRETATION We found no significant difference between adrenaline and TXA for controlling non-catastrophic iatrogenic endobronchial bleeding after cold saline failure, adding to the body of evidence that TXA can be used safely and effectively during FB. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov; No.: NCT04771923; URL: www. CLINICALTRIALS gov.

Abstract

BACKGROUND COVID-19 is a viral prothrombotic respiratory infection. Heparins exert antithrombotic and anti-inflammatory effects, and might have antiviral properties. We aimed to investigate whether thromboprophylaxis with enoxaparin would prevent untoward hospitalisation and death in symptomatic, but clinically stable outpatients with COVID-19. METHODS OVID was a randomised, open-label, parallel-group, investigator-initiated, phase 3 trial and was done at eight centres in Switzerland and Germany. Outpatients aged 50 years or older with acute COVID-19 were eligible if they presented with respiratory symptoms or body temperature higher than 37·5°C. Eligible participants underwent block-stratified randomisation (by age group 50-70 vs >70 years and by study centre) in a 1:1 ratio to receive either subcutaneous enoxaparin 40 mg once daily for 14 days versus standard of care (no thromboprophylaxis). The primary outcome was a composite of any untoward hospitalisation and all-cause death within 30 days of randomisation. Analysis of the efficacy outcomes was done in the intention-to-treat population. The primary safety outcome was major bleeding. The study was registered in ClinicalTrials.gov (NCT04400799) and has been completed. FINDINGS At the predefined formal interim analysis for efficacy (50% of total study population), the independent Data Safety Monitoring Board recommended early termination of the trial on the basis of predefined statistical criteria having considered the very low probability of showing superiority of thromboprophylaxis with enoxaparin for the primary outcome under the initial study design assumptions. Between Aug 15, 2020, and Jan 14, 2022, from 3319 participants prescreened, 472 were included in the intention-to-treat population and randomly assigned to receive enoxaparin (n=234) or standard of care (n=238). The median age was 57 years (IQR 53-62) and 217 (46%) were women. The 30-day risk of the primary outcome was similar in participants allocated to receive enoxaparin and in controls (8 [3%] of 234 vs 8 [3%] of 238; adjusted relative risk 0·98; 95% CI 0·37-2·56; p=0·96). All hospitalisations were related to COVID-19. No deaths were reported during the study. No major bleeding events were recorded. Eight serious adverse events were recorded in the enoxaparin group versus nine in the control group. INTERPRETATION These findings suggest thromboprophylaxis with enoxaparin does not reduce early hospitalisations and deaths among outpatients with symptomatic COVID-19. Futility of the treatment under the initial study design assumptions could not be conclusively assessed owing to under-representation of older patients and consequent low event rates. FUNDING SNSF (National Research Programme COVID-19 NRP78: 198352), University Hospital Zurich, University of Zurich, Dr-Ing Georg Pollert (Berlin), Johanna Dürmüller-Bol Foundation.

Abstract

PURPOSE In this study, we investigated the effect of reverse Trendelenburg position (RTP), with five, ten, and twenty degrees, on intraoperative bleeding and postoperative edema and ecchymosis around the eye in open rhinoplasty operations. MATERIALS AND METHODS Ninety patients undergoing open rhinoplasty were divided into three groups, 5° angle RTP (Group 5; n = 30), 10° angle RTP (Group 10; n = 30), and 20° angle RTP (Group 20; n = 30). After 3 min of preoxygenation, anesthesia was induced with 3 mg.kg(-1) propofol, 1 μg.kg(-1) fentanyl, and 0.6 mg/kg rocuronium for muscle relaxation. Maintenance of anesthesia was provided with a minimum alveolar concentration of 1-1.5 with sevoflurane, 1:1 O2/N2O. Hemodynamic variables, intraoperational bleeding, postoperative 1st, 3rd and 7th days ecchymosis and edema around the eyes of the patients were compared between the groups. RESULTS Edema changes on postoperative 1st, 3rd and 7th days and ecchymosis changes around the eyes on postoperative 1st and 3rd days in Group 20 were found significantly lower than Group 5 (p < 0.017). Besides, the change of ecchymosis on the postoperative 1st day was found significantly lower in Group 20 compared to Group 10 (p < 0.017). The amount of intraoperative bleeding and surgical field evaluation score were found to be significantly lower in Group 10 and Group 20 compared to Group 5 (p < 0.017). CONCLUSION We concluded that in open rhinoplasty surgeries, 20° degree RTP reduces intraoperative blood loss and provides a more bloodless surgical field, as well as reducing edema and ecchymoses around the eyes in the postoperative period.

Abstract

PURPOSE A seroma is a collection of exudates after surgical trauma in wound healing. Fibrin glue is used to prevent seroma by reducing the generation of exudate. However, the impact of fibrin glue on the prevention of seroma remains debatable. Therefore, we conducted a randomized controlled pilot trial to investigate the effect of the amount of fibrin glue used on the generation of exudate after thyroidectomy and the sample size of future definitive trials. METHODS Between February and December 2020, 41 patients were enrolled; 21 patients in the low fibrin group and 20 in the high fibrin group. Stratified randomization was performed based on sex, body mass index, and thyroiditis. All patients underwent total thyroidectomy and bilateral central compartment dissection. In the low and high fibrin groups, 2 mL and 6 mL of fibrin glue were applied to patients, respectively. RESULTS Both the total drain volume and flow rate during the first 12 hours were lower in the high fibrin group than in the low fibrin group (65.0 mL vs. 47.6 mL, P = 0.008 and 2.7 mL/hr vs. 1.8 mL/hr, P = 0.002, respectively). The calculated sample size for future randomized controlled trial was 32 patients (α = 0.05, power = 0.8), and the power of this trial was 0.91 with µ(1) = 2.7, µ(2) = 1.8, σ = 0.9, and α = 0.05 (µ = mean, σ = standard deviation). CONCLUSION Six milliliters of fibrin glue could reduce total drain volume and flow rate of exudate after thyroidectomy. Therefore, applying an appropriate amount of fibrin glue after thyroidectomy may reduce postoperative seroma.

Abstract

INTRODUCTION The effectiveness of hemorrhoidal artery ligation supplementation in reducing the incidence of post laser hemorrhoidoplasty bleeding has not been investigated. METHODS This was a double-blind, randomized controlled trial comparing post-operative bleeding incidence in patients undergoing laser hemorrhoidoplasty (LHP) only versus LHP with hemorrhoidal artery ligation (HAL). Outcome measures included post-operative bleeding and its severity (i.e. verbal rating scale and Clavien-Dindo classification), presence of perianal swelling and pain score (visual analog score) at 1-day, 1-week and 6-weeks post-operatively. Statistical tests were performed and a value of P < 0.05 was considered significant. RESULTS Seventy-six patients were randomized. There was no difference in median operating time. The bleeding incidence was highest at 1-week post-operatively (17.1%), and decreased to 1.3% at 6-weeks. There was no significant difference in bleeding incidence between both groups at any of the measured timepoints (P > 0.05). Severity of bleeding and incidence of post-operative perianal swelling were similar in both groups (P > 0.05). There was no difference in median pain scores. CONCLUSION Supplementation of HAL to LHP does not reduce the post-operative bleeding incidence. LHP is sufficient as a stand-alone procedure for treating haemorrhoids. TRIAL REGISTRATION National Registration Number is NMRR-15-1112-24065 (IIR). The trial start date was 1st January 2015 with the ClinicalTrials.gov identifier and registration number as NCT04667169.