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

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 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.

Abstract

OBJECTIVE To evaluate the clinical efficacy of intralesional platelet-rich plasma (PRP) injections compared to intralesional triamcinolone acetonide (TA) injections in the treatment of erosive oral lichen planus (EOLP). MATERIAL AND METHODS Twenty patients with EOLP were assigned randomly to either PRP or TA group. Patients received weekly intralesional injections for 4 weeks, and then followed up for 3 months on regular visits every 2 weeks. Pain scores using numerical pain score and clinical score were recorded by a blinded assessor each visit for all patients and remission score at the end of the trial was recorded. RESULTS Both groups showed significant improvement in the clinical parameters (pain and clinical score) "p = .001." Regarding remission of the lesions, 80% of patients in the PRP group showed complete remission compared to 70% in the TA group. However, there is no statistical significance when comparing the two groups in pain score, clinical score, or remission. CONCLUSIONS PRP injections could be considered as an effective alternative single treatment modality for EOLP. The protocol for this study registered in Clinicaltrials.gov registry under the identifier number: NCT03293368.

Abstract

BACKGROUND Several biomaterials have been suggested to augment the jumping gap during immediate implant placement. PURPOSE The aim of this study was to compare the effect of xenograft or platelet derived growth factor (PRF) to graft the jumping gap in immediate implant placement in the maxillary premolar region. MATERIALS AND METHODS Twenty patients underwent atraumatic extraction followed by immediate placement. The patients were equally divided into two groups. The first group received xenograft as a jumping gap filling material. The second group received PRF to graft the jumping gap. All patients received preoperative, immediate postoperative, and 6 months postoperative cone beam CT scan (CBCT). Implant stability quotient ISQ values were taken for the installed implants immediate postoperative and at 6 months. RESULTS Implants receiving PRF as a jumping gap graft material demonstrated a significantly greater amount of crestal bone loss 1.85 ± 0.89 mm as compared to xenograft group 0.77 ± 0.32 mm (t = 3.52, p = 0.005). PRF group showed significantly greater reduction in buccopalatal direction 1.63 mm as compared to xenograft group 0.59 mm (t = 4014, p <0.001). ISQ values were similar immediately postoperative (t = 0.070, p = 0.945) while the ISQ values were significantly lower in PRF group as compared to xenograft graft at the six-month interval (t = 0.248, p = 0.023). CONCLUSION The use of xenograft material as a jumping gap filling material resulted in superior results compared to PRF with regards to crestal bone loss, buccolingual socket reduction, and ISQ values.

Abstract

BACKGROUND The optimal fluid strategy to prevent maternal hypotension during caesarean delivery remains unclear. This study aim was to compare the incidence of post-spinal anaesthesia hypotension in women receiving either colloid or crystalloid coload in the setting of prophylactic phenylephrine infusion during caesarean delivery. METHODS Healthy mothers undergoing elective caesarean delivery under spinal anaesthesia were randomised to receive a rapid intravenous coload with 6% hydroxyethyl starch 130/0.4 10 mL/kg (colloid group) or balanced crystalloid solution (Plasma Solution A) 10 mL/kg (crystalloid group) during spinal anaesthesia. All women had a prophylactic phenylephrine infusion initiated at 25 μg/min immediately after the subarachnoid block and titrated to systolic blood pressure using a standardised protocol. The primary outcome was the incidence of hypotension (systolic blood pressure <80% of baseline) until delivery. RESULTS The incidence of hypotension was 50% in the colloid group and 62% in the crystalloid group (absolute difference, -12% [95% CI -33% to 9%]; relative risk, 0.8 [95% CI 0.56 to 1.14]; P=0.314). No significant difference between groups was found in the number of hypotensive episodes (median 0.5 [IQR 0 to 1] vs 1 [0 to 2], P=0.132) or phenylephrine dose (675 [IQR 425 to 975] μg vs 750 [625 to 950] μg, P=0.109). The incidence of severe hypotension, symptomatic hypotension, bradycardia, nausea, and the neonatal outcomes were not significantly different. CONCLUSIONS This study found no benefit of colloid coload compared with crystalloid coload for preventing maternal hypotension in the presence of prophylactic phenylephrine infusion during caesarean delivery.