Scaling up Quality Improvement for Surgical Teams (QIST)-avoiding surgical site infection and anaemia at the time of surgery: a cluster randomised controlled trial of the effectiveness of quality improvement collaboratives to introduce change in the NHS
Implementation science : IS. 2022;17(1):22
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.
Local administration of epsilon-aminocaproic acid reduces post-operative blood loss from surgery for closed, Sanders III-IV calcaneal fractures
International orthopaedics. 2022
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.
Peroperative Intra-Articular Infiltration of Tranexamic Acid and Ropivacaine Cocktail in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
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.
Prospective Comparison of Functional and Radiological Outcomes of Arthroscopic Anterior Cruciate Ligament Reconstruction by Hamstring Graft Alone and Platelet-Rich Plasma Added to the Hamstring Graft
AIMS AND OBJECTIVES To measure the additional effect of platelet-rich plasma (PRP) on functional outcome of anterior cruciate ligament tear managed by augmenting anterior cruciate ligament (ACL) reconstruction with PRP. METHODS The present study was conducted on patients with ACL tear admitted in the department of orthopaedics, King George's Medical University, Lucknow wherein a total of 70 subjects were assigned into two groups of 35 patients each randomly, viz Group 1 in which the patients were treated by quadruple hamstring graft alone and Group 2 in which the patients were treated with augmented hamstring graft with PRP. The standardized anterior drawer test, Lachman's test, Lysholm knee score were quantified both preoperatively and postoperatively at different follow-ups and also tibial tunnel widening was measured postoperatively at different follow-ups. RESULT The present study had 70 patients with ACL tears. The mean age of patients in non-PRP groups was 29.71 ±2.99 years while that in the PRP group was 28.34±4.32 years. On comparing the improvement in grades at pre-op, immediate postop, 6 weeks, and 3 months follow-ups, there was no statistically significant difference between the two groups. The tibial tunnel widening also showed no significant difference between the two groups. CONCLUSION In our study, it was found that both the groups showed improvements in grades of anterior drawer test and Lachman's test postoperatively but the difference between both the groups was not significant. Similarly, while comparing the improvements in Lysholm knee score and tibial tunnel widening among both the groups, the difference was not significant. Follow up of 3 months was a limiting factor in our study. This technique needs further clinical evaluation to assess the long-term results.
Intra-articular Versus Intravenous Tranexamic Acid in Primary Total Knee Replacement
Background Total knee replacement (TKR) is an artificial joint surgical procedure that replaces the damaged articular surfaces of the knee joint. Despite several studies on the efficacy of intra-articular and intravenous Tranexamic acid (TX) use in reducing blood loss following TKR, the route of TXA administration is still an ongoing topic of debate. Our study aimed to compare total knee replacement efficacy (hemoglobin level, hematocrit level, hospital stay, and complications) of intra-articular and intravenous tranexamic acid administration. Material and Methods A Prospective study was conducted at the Department of Orthopedics, Shifa International Hospital, Islamabad. The study duration was six months (August 2020 to February 2021). A sample size of 60 patients was calculated using the WHO calculator. Patients were selected through non-probability consecutive sampling. Patients were randomly divided into two groups; Group A was given intraarticular TXA, while group B was given intra-venous TXA following total knee replacement. Patients were followed for 48 hours. Data were analyzed using SPSS version 24. An Independent T-test was applied, and a P value≤0.05 was considered significant. Results A total of 60 patients were included in the study. There were 20 (33.3%) male and female 40 (66.7%). The mean age of patients was 64.4±10.8SD. Post-operative hemoglobin level in group A was 11.09±0.39SD, and in group B was 9.93±1.73SD (p=0.03). Postoperatively, the mean HCT level in group A was 30.53±4.26SD and group B 26.88±5.48SD (p=0.01). Conclusion Intra-articular administration of TXA is more effective than intravenous administration in controlling postoperative blood loss following total knee replacement.
Finding the optimal regimen for short-term daily recombinant human erythropoietin treatment for blood-saving purpose in patients undergoing unilateral primary total hip arthroplasty: a double-blinded randomized placebo-controlled trial
BMC musculoskeletal disorders. 2022;23(1):243
PURPOSE To find the best short-term daily recombinant human erythropoietin (rhEPO)-based treatment protocols for blood-saving purpose in THA. METHOD The patients were randomized to 1 of 3 interventions: Patients in group A received 10,000 IU (150 IU/kg) of subcutaneous rhEPO (1 ml) daily from 5 days preoperatively to 3 days postoperatively (9 doses in total); Patients in group B received 1 ml of subcutaneous normal saline daily from 5 days preoperatively to 3 days preoperatively and then 10,000 IU (150 IU/kg) of subcutaneous rhEPO daily until 3 days postoperatively (6 doses in total). Patients in group C received 1 ml of subcutaneous normal saline daily from 5 days preoperatively to one day preoperatively and then 10,000 IU (150 IU/kg) of subcutaneous rhEPO daily from the day of surgery to 3 days postoperatively (4 doses in total). RESULTS One hundred eighty patients were included. On postoperative day one, patients in the group A showed significantly higher Hb level (108.4 ± 11.4 g/L) than group C (103.9 ± 8.8 g/L). Group B (107.8 ± 8.4 g/L) also showed significantly higher Hb level than group C (103.9 ± 8.8 g/L) (p < 0.05). On postoperative day 3, no significant difference was found between group B and group C in Hb level (98.7 ± 10.5 and 94.9 ± 8.7 g/L, respectively) (p = 0.094), but the Hb level in group A (103.6 ± 11.0 g/L) was still markedly higher than in group B and the Hb level in group A was also markedly higher than in group C. In terms of blood loss, no markedly difference was found in intraoperative blood loss among group A, B and C (78.3 ± 22.4, 84.6 ± 29.1, and 80.3 ± 23.9 ml, respectively) (p = 0.381), but on postoperative day one, the mean blood loss in group C (522.4 ± 189.4 ml) was significantly more than group B (371.2 ± 124.6 ml), and group B was also significantly more than group A (284.8 ± 112.9 ml) with 95% confidence interval, and group B had significantly less blood loss than group C (p < 0.001). With respect to the total blood loss, the total blood loss in group C (881.6 ± 314.9 ml) was significantly more than group B (642.6 ± 232.9 ml), and group B was also significantly more than group A (514.5 ± 204.6 ml) with 95% confidence interval (Table 2). Only 2 patients in each group received allogeneic blood transfusion and each patient received 2 units of red blood cells, so, the transfusion requirements among the three groups were comparable. CONCLUSIONS Daily small-dose of subcutaneous rhEPO administered from 5 days before THA could significantly decrease perioperative blood loss and improve postoperative Hb levels, without increasing risks of complications, when compared with the application of rhEPO from 3 days before THA or from the day of surgery. However, surgeons should choose the regimen individually according to different patients' personal circumstances.
Platelet-Rich Plasma and Adipose-Derived Mesenchymal Stem Cells in Association with Arthroscopic Microfracture of Knee Articular Cartilage Defects: A Pilot Randomized Controlled Trial
Advances in orthopedics. 2022;2022:6048477
BACKGROUND This study aims to compare the effects of platelet-rich plasma (PRP) alone or in combination with adipose-derived mesenchymal stem cells (AD-MSCs) in patients affected by cartilage defects, undergoing knee arthroscopic microfracture. METHODS Thirty-eight patients diagnosed with a knee monocompartmental cartilage defect (Outerbridge grade IV) on the MRI, underwent an arthroscopic procedure. After the confirmation of the lesion, they all received the same bone marrow stimulation technique (microfracture) and were randomized into two groups: the first one had additional PRP injection (group A), while the second received PRP and AD-MSC injection (group B). Knee assessment and pain score were documented with Knee Injury Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, Short-Form (SF) 12, and Visual Analogue Scale (VAS) before the treatment and at 1, 3, 6, and 12 months of follow-up postoperatively. An additional arthroscopic procedure, performed in four patients for a subsequent meniscal lesion, let us evaluate cartilage evolution by performing a macro/microscopical assessment on cartilage biopsy specimens. RESULTS At the 12-month follow-up, both groups showed a comparable functional improvement. The scores on the IKDC form, KOOS, pain VAS, and SF-12 significantly improved from baseline (p < 0.05) to 12 months postoperatively in both treatment groups. The four second-look arthroscopies showed a complete repair of the articular defects by smooth solid cartilage layer, with a good chondrocytic population, in both groups. A thick smooth hyaline-like cartilage with a predominantly viable cell population and normal mineralization (a form closely resembling native tissue) was observed in group B. CONCLUSIONS Modern regenerative medicine techniques, such as PRP and AD-MSC, associated with traditional arthroscopic bone marrow stimulating techniques, seem to enhance cartilage restoration ability. The preliminary results of this pilot study encourage the synergic use of these regenerative modulating systems to improve the quality of the regenerated cartilage.
A prospective randomized study, use of closed suction drainage after revision hip arthroplasty may lead to excessive blood loss
Scientific reports. 2022;12(1):881
Suction drainage after primary total hip arthroplasties (THA) offers no benefits. Revision hip arthroplasties (RHA) are more demanding procedures and associated with greater blood loss compared to primary cases. There is still a lack of literature regarding the application of drainage in RHA. A total of 40 patients who underwent RHA were included in this prospective study. Simple randomization with an allocation ratio 1:1 was performed. Primary outcomes: total blood loss, hemoglobin drop, joint hematoma size in USG, infection. Secondary outcomes: blood transfusion rate, soft tissue hematomas, C-reactive protein levels, Visual Analogue Scale before and on 3rd day after surgery, Harris Hip Score before and 6 weeks after surgery. An intention to treat analysis was performed, with a 2-year follow up. Statistically significant differences between groups was in blood loss: drainage 1559.78 ml, non-drainage 1058.27 ml, (p = 0.029) and hemoglobin level on 1st day after surgery: drainage 10.58 g/dl, non-drainage 11.61 g/dl (p = 0.0496). In terms of the other analyzed parameters, statistical differences were not found. Our study revealed that the use of suction drainage may lead to higher blood loss in the early postoperative period. Further studies are needed to evaluate our results.
Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery
Revista espanola de cirugia ortopedica y traumatologia. 2022
OBJECTIVE Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in two parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS Total blood loss (TBL) for the placebo group was 831.5 ml and 662.3 ml for the TXA group. The difference between the two groups was 169.2 ml; which means a save of 20.4 per cent; this difference being statistically significant (p<0.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.
Application of Different Doses of Tranexamic Acid Plus Traditional Chinese Medicine in Hip Arthroplasty in Patients with Diabetes and Its Influence on Intraoperative Blood Loss and Postoperative Drainage
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:1197495
OBJECTIVE To evaluate the efficacy of different doses of tranexamic acid plus traditional Chinese medicine (TCM) in hip arthroplasty in diabetic patients and the effect on intraoperative hemorrhage and postoperative drainage. METHODS One hundred patients admitted to our hospital from January 2019 to September 2021 were randomly divided into group B (n = 50) and group A (n = 50), and tranexamic acid was injected intravenously at a dose of 10 mg/kg and 20 mg/kg 30 min before skin incision, and then tranexamic acid 1.0 g was injected into the joint cavity through the drainage after incision closure, followed by 3 h of drainage clamping. The amount of blood loss, coagulation index, postoperative drainage, and incidence of venous thromboembolism (VTE) were compared between the groups. RESULTS Group A had significantly less total blood loss, dominant blood loss, and hidden blood loss than group B (P < 0.05). No significant difference in postoperative coagulation indexes and postoperative drainage flow was found between the two groups (P > 0.05). Serological examination results demonstrated no statistical difference in D-dimer (D-D) levels between the two groups. The absence of VTE in both groups was determined by imaging. CONCLUSION Tranexamic acid is effective in reducing intraoperative hemorrhage in diabetic patients undergoing hip arthroplasty. The dose of 20 mg/kg outperforms 10 mg/kg in terms of clinical efficacy with a favorable safety profile, which can be applied according to the patient's actual condition.