Abstract

OBJECTIVE To evaluate the safety and efficacy of using ergometrine maleate injection combined with oxytocin injection, with oxytocin injection as the control, to prevent postpartum hemorrhage after vaginal delivery. METHODS A total of 305 cases who underwent vaginal delivery between December 2018 and November 2019 in 16 hospitals across China were enrolled and included in the full analysis set (FAS) and the safety analysis set (SS). Among the 299 subjects who completed the trial, 277 were included in the per protocol set (PPS). The subjects were randomly assigned by 1∶1 ratio to two groups, 152 cases in Group A, the experimental group receiving oxytocin injection plus ergometrine injection, and 153 cases in Group B, the control group, receiving oxytocin injection. The difference in total bleeding volume at 2 h, 6 h and 24 h postpartum in the two groups was documented and compared. Other measures were also compared between the two groups, including the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion, the time of placenta retention, proportion of subjects with prolonged hospital stay due to uterine asthenia, the vital signs, lab test indicators and the incidence of adverse reactions in the two groups. RESULTS The total bleeding volume at 2 h, 6 h and 24 h after delivery was significantly lower in the experimental group (P<0.05). There was no significant difference between the two groups in the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion and the time of placenta retention, heart rate, respiration, lab test indicators, or the incidence of adverse reaction (P>0.05). CONCLUSION Ergometrine maleate injection showed evident therapeutic efficacy in preventing hemorrhage after vaginal delivery, causing fewer adverse reactions and ensuring greater safety, and therefore, presenting promising prospects for clinical application.

Abstract

BACKGROUND The aim of this trial was to assess the effectiveness of quality improvement collaboratives to implement large-scale change in the National Health Service (NHS) in the UK, specifically for improving outcomes in patients undergoing primary, elective total hip or knee replacement. METHODS We undertook a two-arm, cluster randomised controlled trial comparing the roll-out of two preoperative pathways: methicillin-sensitive Staphylococcus aureus (MSSA) decolonisation (infection arm) and anaemia screening and treatment (anaemia arm). NHS Trusts are public sector organisations that provide healthcare within a geographical area. NHS Trusts (n = 41) in England providing primary, elective total hip and knee replacements, but that did not have a preoperative anaemia screening or MSSA decolonisation pathway in place, were randomised to one of the two parallel collaboratives. Collaboratives took place from May 2018 to November 2019. Twenty-seven Trusts completed the trial (11 anaemia, 16 infection). Outcome data were collected for procedures performed between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infection (SSI) caused by MSSA (within 90 days post-surgery) for the anaemia and infection trial arms, respectively. Secondary outcomes were deep and superficial SSIs (any organism), length of hospital stay, critical care admissions and unplanned readmissions. Process measures included the proportion of eligible patients receiving each preoperative initiative. RESULTS There were 19,254 procedures from 27 NHS Trusts included in the results (6324 from 11 Trusts in the anaemia arm, 12,930 from 16 Trusts in the infection arm). There were no improvements observed for blood transfusion (anaemia arm 183 (2.9%); infection arm 302 (2.3%) transfusions; adjusted odds ratio 1.20, 95% CI 0.52-2.75, p = 0.67) or MSSA deep SSI (anaemia arm 8 (0.13%); infection arm 18 (0.14%); adjusted odds ratio 1.01, 95% CI 0.42-2.46, p = 0.98). There were no significant improvements in any secondary outcome. This is despite process measures showing the preoperative pathways were implemented for 73.7% and 61.1% of eligible procedures in the infection and anaemia arms, respectively. CONCLUSIONS Quality improvement collaboratives did not result in improved patient outcomes in this trial; however, there was some evidence they may support successful implementation of new preoperative pathways in the NHS. TRIAL REGISTRATION Prospectively registered on 15 February 2018, ISRCTN11085475.

Abstract

PURPOSE To investigate whether local administration of epsilon-aminocaproic acid (EACA) is effective and safe in reducing the post-operative blood loss in surgery for Sanders III-IV calcaneal fractures. METHODS Patients with Sanders III-IV calcaneal fractures who were hospitalized in our hospital from January 2016 to February 2021 and underwent open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision were included in the current study. Eighty five patients were randomly divided into two groups, EACA group (43) and control group (42). Twenty milliliters of 5% EACA solution or normal saline was perfused into the incision of patients in EACA group and control group, respectively. The volume of post-operative drainage was investigated as the primary outcome. Post-operative blood test, coagulation test, and wound complications were analyzed as the secondary outcomes. RESULTS The volume of post-operative drainage at 24 and 48 h was 164.8 ± 51.4 ml, 18.9 ± 3.8 ml for patients in EACA group, and 373.0 ± 88.1 ml, 21.2 ± 4.4 ml for patients in the control group, respectively. EACA greatly reduced the post-operative blood loss compared to the control (normal saline). The difference between the two groups was statistically significant. No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics. Post-operative blood test results demonstrated that haemoglobin and hematocrit were significantly higher in EACA compared to those of control group. No significant difference was found between EACA group and control group in terms of the platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications. CONCLUSION Local administration of EACA is effective in post-operative blood loss reduction in ORIF surgeries for Sanders III-IV types of calcaneal fractures without increasing the incidence of periwound complication.

Abstract

To summarize and analyze the clinical efficacy and safety of neuroendoscopic surgery (NES) in the treatment of patients for severe thalamic hemorrhage with ventricle encroachment (THVE). Eighty-three patients with severe THVE were treated in the Neurosurgery Department of Anqing Hospital Affiliated to Anhui Medical University from July 2019 to August 2021. Our study was approved by the ethics committee. The patients were randomly divided into NES group and extraventricular drainage (EVD) group. The hospital stay, Glasgow coma scale (GCS) scores on the 1st and 14th days postoperatively, the incidence of intracranial infections, and the clearance of postoperative hematomas were compared and analyzed between the two groups. The patients had follow-up evaluations 6 months postoperatively. The prognosis was evaluated based on the activity of daily living (ADL) score. A head CT or MRI was obtained to determine whether there was hydrocephalus, cerebral infarction, or other related complications. Eighty-three patients were randomly divided into 41 cases of NES group and 42 cases of EVD group. The length of postoperative hospital stay was 17.42 ± 1.53 days, the GCS scores were 6.56 ± 0.21, and 10.83 ± 0.36 on days 1 and 14, respectively; intracranial infections occurred in 3 patients (7.31%) and the hematoma clearance rate was 83.6 ± 5.18% in the NES group, all of which were significantly better than the EVD group (P < 0.05). After 6 months of follow-up, 28 patients (68.29%) had a good prognosis, 5 patients (12.19%) died, and 4 patients (9.75%) had hydrocephalus in the NES group. In the EVD group, the prognosis was good in 15 patients (35.71%), 12 patients (28.57%) died, and 17 patients (40.47%) had hydrocephalus. The prognosis, mortality rate, and incidence of hydrocephalus in the NES group were significantly better than the EVD group (P < 0.05). Compared to traditional EVD, NES for severe THVE had a higher hematoma clearance rate, and fewer intracranial infections and patients with hydrocephalus, which together improve the clinical prognosis and is thus recommended for clinical use.

Abstract

BACKGROUND The treatment of atrophic acne scars represents a therapeutic challenge. Recently, plasma gel has been introduced among treatment modalities. OBJECTIVE To compare the efficacy of platelet-rich-plasma 'fluid' versus 'gel' form combined with fractional CO(2) laser in the treatment of atrophic acne scars. METHODS Twenty-seven patients with atrophic acne scars were included. Treatment with fractional CO(2) laser plus plasma fluid/gel was randomly assigned to the right/left sides of the face. Clinical and Optical Coherence Tomography (OCT) assessments were scheduled at baseline, one month, and three months after the last session. RESULTS There was a significant improvement in clinical assessment scores at third-month follow-up on the plasma gel- and plasma fluid-treated sides compared to those at the first-month follow-up (p < .001). Scar depth decreased significantly at third-month follow-up when compared to baseline on both plasma gel- and plasma fluid-treated sides (p < .001). The numerical pain score was significantly lower on the plasma fluid-treated side compared to the plasma gel-treated side (p = .004). CONCLUSION The use of platelet-rich plasma in combination with fractional CO(2) laser, both in fluid and gel form, produced significant results in the treatment of atrophic acne scars. Patients reported an immediate more noticeable effect with plasma gel. However, the fluid injection was less painful.

Abstract

STUDY OBJECTIVE Preoperative anemia results in two- to sixfold increased incidence of perioperative blood transfusion requirements and reduced postoperative hemoglobin (Hb) level. This prospective study was designed to investigate the effect of preoperative intravenous infusion of iron on Hb levels, blood transfusion requirements, and incidence of postoperative adverse events in patients undergoing coronary artery bypass grafting. DESIGN Prospective randomized trial. SETTING Academic university hospital. PATIENTS Eighty patients (52-67 years old) underwent coronary artery bypass grafting and received either iron therapy or saline infusion preoperatively. INTERVENTIONS Patients were randomly allocated to iron or placebo groups. In the iron group, patients received a single intravenous dose of ferric carboxymaltose (1000 mg in 100 mL saline) infused slowly over 15 min 7 days before surgery. In placebo group, patients received a single intravenous dose of saline (100 mL saline) infused slowly over 15 min 7 days before surgery. MEASUREMENTS Patients were followed up with regards to incidence of anemia, Hb level on admission, preoperatively, postoperatively, 1 week and 4 weeks after discharge, aortic cross-clamp time, the number of packed red blood cells (pRBCs) units, the percentage of reticulocytes pre-postoperatively and 1 week later, hospital stay and intensive care unit (ICU) stay length, and the incidence of postoperative complications. MAIN RESULTS Iron therapy was associated with lower incidence of anemia 4 weeks after discharge (P < 0.001). Hb level was significantly higher in the iron group compared to the placebo group preoperatively and postoperatively, and 4 weeks after discharge (P < 0.001). Iron therapy resulted in shorter hospital and ICU stay (P < 0.001) and shorter aortic cross-clamp time, reduced pRBCs requirements postoperatively. Percentage of reticulocytes was significantly higher in placebo group than in iron group postoperatively and 1 week after discharge and the incidence of postoperative complications was similar to the placebo group. CONCLUSIONS Preoperative IV iron infusion is a safe and feasible way to manage preoperative anemia. Preoperative administration of IV iron is associated with a higher postoperative Hb level, shorter hospital and ICU stay, and reduced perioperative red blood cell transfusion requirements with insignificant difference in incidence of postoperative complications.

Abstract

Background Total knee arthroplasty (TKA) is a procedure that has improved the quality of life of patients with knee arthritis. Postoperative pain and blood loss are the two major drawbacks of TKA which affect patient satisfaction and delay recovery and rehabilitation. Local infiltration analgesia has shown better results in controlling immediate postoperative pain, thus enabling early rehabilitation and mobilization, while local infiltration of antifibrinolytic agents has shown impressive results in controlling blood loss. In this study, we evaluate the effect of a combination of intra-articular infiltration of ropivacaine cocktail along with intra-articular instillation of tranexamic acid in reducing patient-reported postoperative pain and the level of blood loss control after TKA. Methodology Patients presenting with high-grade osteoarthritis and undergoing TKA were included and randomly allocated to two groups: one receiving the intra-articular infiltration (group A), and the other not receiving any infiltration (group B). Postoperative pain was measured through the Visual Analog Scale (VAS) every three hours for the first 24 hours, and then at 48 hours and 72 hours postoperatively. The need for additional analgesia, in the form of a slow epidural infusion, in patients experiencing severe postoperative pain was evaluated in both groups. Postoperative blood loss was assessed by measuring total drain output (in mL) and by comparing preoperative and postoperative (at 24 hours) hemoglobin, hematocrit drift, and blood transfusion rates. The duration of the postoperative hospital stay and the time taken to start postoperative knee mobilization exercises and weight-bearing were noted to assess the recovery and rehabilitation of the patients in the two groups. Results The study included 42 patients (group A, 22 patients; group B, 20 patients) with 28 knees in each group. Patients with intra-articular infiltration using ropivacaine cocktail with tranexamic acid showed excellent pain control compared to the non-infiltrated patients in the early 48 hours postoperatively. There was a significant drop in postoperative hemoglobin and hematocrit values in the non-infiltrated patients compared to the other group. Further, the intra-articular infiltration-instillation significantly reduced blood loss through the drain, the requirement of postoperative blood transfusions, and the duration of hospital stay. Conclusions It can be safely concluded that ropivacaine cocktail and tranexamic acid instillation postoperatively in knee arthroplasty patients is a very useful and effective technique to reduce postoperative pain and blood loss.

Abstract

BACKGROUND Canadian Blood Services (CBS) screens donors based on group status (e.g., men who have sex with men, MSM) instead of specific, high-risk sexual practices (e.g., occurrence of condomless sex). The MSM screening question is embedded in a cluster of questions about stigmatized attributes such as history of imprisonment and illicit substance use. This juxtaposition of the "MSM question" and stigmatized attributes may unintentionally cause blood donors to perceive MSM more negatively. The aim of this research is to determine whether the CBS donor eligibility questionnaire generates negative bias against MSM. STUDY DESIGN AND METHODS A national, randomized online study of 903 CBS donors was conducted. Participants completed either the existing blood donor eligibility questionnaire or a modified donor questionnaire that repositioned the MSM question among neutral questions. After completing the existing or modified questionnaire, bias against MSM was measured using the sexuality implicit association test (IAT) and Modern Homonegativity Scale - Gay Men (MHS-G). Lastly, participants estimated prevalence rates among MSM of certain stigmatized behaviors. RESULTS Participants who completed the existing donor eligibility questionnaire more strongly associated gay men with negative attributes on the IAT (p(one-tailed) = .045), suggesting question position generated implicit negative bias toward MSM. Responses to the MHS-G (p(one-tailed) = .506) and prevalence estimation task (p = .443) indicated that question order had no significant impact on explicit bias. DISCUSSION Positioning the MSM screening question among stigmatizing questions creates implicit negative bias against MSM. Policy makers should be mindful of question positioning when designing donor questionnaires.

Abstract

BACKGROUND Some studies have recommended combining germinal matrix excision with phenol ablation in the treatment of onychocryptosis. Matrixectomy after phenolization has been shown to be an effective modification to reduce the drawbacks associated with phenolization alone, although it increases the risk of minor postoperative bleeding. The present study aims to assess the effectiveness and safety of gelatin sponges as hemostatic agents in partial matrixectomy after phenolization. METHODS A comparative clinical trial in parallel groups was designed in 74 halluces (44 patients) with stage I, II, and III onychocryptosis. All participants were randomly assigned to 3 groups: Group A (control group), Group B (conventional gelatin sponge), and Group C (high porosity gelatin sponge). RESULTS The quantified mean blood loss in the first 48 h after surgery in patients in both experimental groups was significantly lower compared to the control group. The lowest mean blood loss was recorded in Group C (p < 0.001) and followed by Group B (p = 0.005). No adverse effects were recorded in any of the patients included in the experimental groups. CONCLUSIONS Hemostatic gelatin sponges were demonstrated to be effective and safe devices for the control of minor postoperative bleeding associated with matrixectomy after segmental phenolization.