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1.
An alternative method for personalized tourniquet pressure in total knee arthroplasty: a prospective randomized and controlled study
Wu J, Fu Q, Li H, Han Y, Deng J, Chen Y, Qian Q
Scientific reports. 2022;12(1):9652
Abstract
Tourniquet use always carries potential risks, which can range from mild transient functional impairments of thigh pain, skin blisters to severe permanent dysfunction of limb paralysis, nerve injuries or compartment syndrome. The ideal method for minimizing intraoperative tourniquet pressure (TP) for reducing postoperative complications remains controversial. In this prospective, randomized and controlled study, we reinvestigated an estimation formula for TP based on thigh circumferences and systolic blood pressure (SBP) with two traditional methods for TP determination in total knee arthroplasty (TKA): SBP plus 100 mmHg and a fixed value of 300 mmHg. TP values and postoperative thigh pain scores were compared among three groups. The intraoperative TP value of the formula-calculated group was lower than that of the traditional groups (14.7 mmHg, P = 0.3475 and 94.7 mmHg, P < 0.0001, respectively), while no differences of hemostatic effect at the surgical fields and wound complications were detected among groups. The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery. Estimation method for TP was easy and rapid, without relying on specific equipment. It could provide a practical low TP and comparable hemostatic effect in TKA using an inflating tourniquet.
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2.
Prospective, randomized, controlled, noninferiority clinical trial to evaluate the safety and efficacy of absorbable macroporous polysaccharide composites as adjunct to hemostasis during open surgery
Li H, Li Z, He X, Zhang F, OuYang Z, Wu G, Liu P, Yang S, Dong L, Zhen M, et al
Journal of cardiac surgery. 2022
Abstract
BACKGROUND To address intraoperative bleeding in cardiac surgery, reducing blood transfusion requirements, is mandatory to achieve effective hemostasis. Hemostatic agents may limit localized persistent bleeding. The introduction of carboxymethyl-chitosan component into the hemostatic agent and the application of the radiation crosslinking technique maintain its capacity for achieving intraoperative hemostasis, thus increasing the clinical utility. METHODS A prospective, noninferiority and randomized controlled clinical trial to compare the safety and efficacy of absorbable macroporous polysaccharide composites (AMPC, treatment group) with compound microporous polysaccharide hemostatic powder (CMPHP, control group) (2:1 ratio) as adjuncts to hemostasis in open surgery. The main indication was used for hemostasis in various traumatic hemorrhage areas, including cardiothoracic, vascular, and general surgery. The primary endpoint was success rate of hemostasis within 300 s (at a 10% noninferiority margin). The secondary endpoint was hemostasis time. Both endpoints were assessed in the modified intention-to-treat (MITT) population. Safety parameters were assessed. This study is fully compliant with the CONSORT statement. RESULTS Randomized patients in AMPC and CMPHP groups were 168 and 84, respectively. In MITT population, the success rates of hemostasis within 300 s were 98.8% (163 of 165) in AMPC and 94.0% (78 of 83) in CMPHP (treatment difference 4.8% [95% CI -0.57% to 10.20%]). AMPC was thus noninferior to CMPHP. Hemostasis time (median [interquartile range]) with AMPC (87 [52.5, 180] s) was better than CMPHP (110 [54.5, 181] s). Changes in laboratory parameters over time and shifts to abnormal values were typical of surgeries and similar between two groups. No noticeable adverse effects associated with AMPC or CMPHP were observed. CONCLUSIONS AMPC is well tolerated as topical hemostatic agent, noninferior to commercial CMPHP, and exhibits excellent safety. This study provides a novel hemostatic agent which appears to offer significant clinical advantage in various hemorrhage areas.
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3.
Association of iron supplementation with risk of transfusion, hospital length of stay, and mortality in geriatric patients undergoing hip fracture surgeries: a meta-analysis
Chen R, Li L, Xiang Z, Li H, Hou XL
European geriatric medicine. 2021;12(1):5-15
Abstract
AIMS: To assess the efficacy and safety of iron supplementation for perioperative anemia in geriatric patients with hip fracture. METHODS A systematic search was conducted for studies published using PubMed, EMBASE and Cochrane Library Databases that compared iron supplementation with placebo in patients undergoing hip fracture surgery. The outcomes were blood transfusion rate and volume, length of stay, infection and mortality (last follow-up). Sub-group and sensitivity analyses were performed in cases of substantial heterogeneity. RESULTS The meta-analysis (6 studies: 1201 patients) indicated that iron supplements were not associated with reducing blood transfusion rate (OR 0.92, 95% CI 0.60-1.41; P = 0.69), but high heterogeneity (I(2) = 61%) was detected and a significant association was found in sensitivity analysis of four studies (n = 637; OR 0.68, 95% CI 0.49-0.95; P = 0.02). A significant reduction was detected in transfusion volume (two studies: n = 234; MD - 0.45 units/patient, 95% CI - 0.74 to - 0.16; P = 0.002), hospital stay (five studies: n = 998; MD - 1.42, 95% CI - 2.18 to - 0.67; P = 0.0002) and caused no increased risk of mortality (five studies: n = 937; OR 0.94, 95% CI 0.65-1.36; P = 0.76) and infection (four studies: n = 701; OR 0.58, 95% CI 0.38-0.90; P = 0.01). Sub-group analyses of four studies showed that the preoperative intravenous use of iron at 200-300 mg (two studies) may be the beneficial option for hip fractures patients. CONCLUSIONS Iron supplementation, especially preoperative intravenous use of 200-300 mg iron, is safe and associated with reducing transfusion requirement and hospital stay. Unfortunately, data were too limited to draw a definite conclusion. Further evaluation is required before recommending iron supplementation for older patients with hip fracture surgeries.
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4.
Intravenous Tranexamic Acid Improves the Intraoperative Visualization of Endoscopic Sinus Surgery for High-Grade Chronic Rhinosinusitis: A Randomized, Controlled, Double-Blinded Prospective Trial
Yang W, Gou H, Li H, Liu Y, Wan Y, Wang C, Wang G, Zhang L
Frontiers in surgery. 2021;8:771159
Abstract
Objective: Intraoperative bleeding during endoscopic sinus surgery (ESS) for high-grade rhinosinusitis can be serious and can further obscure the surgical field. This study was designed to evaluate the effect of tranexamic acid (TXA) on the surgical visualization of ESS for high-grade rhinosinusitis. Methods: In total, 60 patients with high-grade chronic rhinosinusitis (Lund-Mackay score 12 or greater) treated by ESS were randomized into two groups: the control group (Group C) or the TXA group (Group T). Each group included 30 patients. Patients in Group T received intravenous TXA, and those in Group C received normal saline. The Boezaart grading scale (BS) score was assessed as the primary outcome. Total blood loss (TBL), whole blood coagulation, and fibrinolysis were assessed by Sonoclot analysis, and complications were recorded and compared between the groups. Result: A significant difference was found in the BS score between Group T and Group C [2.02 (1.88-2.05) vs. 2.27 (2.13-2.41), P = 0.011]. Increases in platelet function (PF) and fibrin degradation time (FDT) were assessed during the operation and showed significant differences between Group T and Group C (P = 0.040 for PF; P = 0.010 for FDT). No difference in complications was found between the two groups. Conclusion: A 15 mg/kg bolus of intravenous TXA before surgery can improve the surgical visualization of ESS for high-grade chronic rhinosinusitis without causing significant adverse effects. Intravenous TXA may be beneficial in ESS for high-grade chronic rhinosinusitis. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=121653&htm=4.
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5.
Effects of platelet-rich fibrin combined with guided bone regeneration in the reconstruction of peri-implantitis bone defect
Sun G, Cao L, Li H
American journal of translational research. 2021;13(7):8397-8402
Abstract
OBJECTIVE To investigate the clinical effect of platelet-rich fibrin (PRF) combined with guided bone regeneration (GBR) in the reconstruction of peri-implantitis bone defect. METHODS This prospective study included 80 patients with peri-implantitis who underwent implant restoration in the Department of Stomatology in our hospital. The eligible patients were randomly divided into control group and observation group, with 40 cases in each group. Patients in the control group were treated with flap curettage combined with GBR, while those in the observation group received a mixture of PRF and bone powder implanted with GBR and covered with PRF biofilm. The differences of pain 24 hours after surgery, bleeding at 7 days after surgery, and the degree of bone defect between the two groups at 60 days after surgery were compared. At 60 days and 120 days after surgery, separately, the regenerated bone density of patients in the two groups was measured, analyzed and compared. The degree of regenerated bone defect in transverse and longitudinal directions after 60 days was compared between the two reconstruction procedures. RESULTS The pain at 24 hours after surgery and the bleeding at 7 days after surgery in the observation group were milder than those in the control group (P<0.001). There was significant difference in the degrees of bone defect at 60 days after surgery (P<0.05). Compared with the control group, the regenerated bone density of the observation group was significantly higher both at 60 days and 120 days after surgery (P<0.001). CONCLUSION The combination of PRF and GBR technology has an obvious effect in repairing bone defects in patients with peri-implantitis, and can reduce the pain of patients during the repair process.
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6.
Assessment of Bone Formation After Secondary Alveolar Bone Grafting With and Without Platelet-Rich Plasma Using Computer-Aided Engineering Techniques
Chen S, Liu B, Yin N, Wang Y, Li H
The Journal of craniofacial surgery. 2020
Abstract
The aim of this study was to analyze the newly formed bone volume (FV), 6 months after secondary alveoloplasty using iliac cancellous bone graft, with and without platelet-rich plasma (PRP). Forty patients with unilateral alveolar cleft were involved in this randomized, prospective, comparative study, with 20 patients each forming the control (group A) and PRP (group B) groups, respectively. The preoperative alveolar defect volume (DV) and the postoperative FV were automatically calculated by the computer-aided engineering software using the patients' pre and postsurgical computed tomography data. The volume of the actual bone graft (AV) was identical to the DV calculated before surgery. The bone formation ratio (BF%) was calculated as follows: BF% = (FV/AV) x 100%. The mean BF% was 42.54 +/- 9.32% in group A and 46.97 +/- 18.49% in group B. There was no statistically significant difference between the 2 groups for BF% (P > 0.05). The study presents a fast and accurate method for assessing the effect of PRP in alveolar grafting. However, the study found no conclusive evidence on the effect of PRP on bone growth.
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7.
Two Doses of Tranexamic Acid Reduce Blood Loss in Primary Posterior Lumbar Fusion Surgery: A Randomized-controlled Trial
Zhu X, Shi Q, Li D, Wu J, Guo K, Zheng X, Li H
Clin Spine Surg. 2020
Abstract
PURPOSE Tranexamic acid (TXA) has been widely used in hip and knee arthroplasty to reduce perioperative blood loss and blood transfusion, but the dosage and efficacy of TXA in posterior lumbar spinal surgery are not fully clear. The aim of this study was to investigate the efficacy and safety of TXA and to determine whether 2 doses of TXA could reduce the blood loss in primary single-segment or double-segment posterior lumbar fusion surgery. MATERIALS AND METHODS A total of 150 patients with lumbar degenerative disease undergoing posterior lumbar interbody fusion surgery between October 2017 and February 2019 were randomized to 3 groups. Group A was treated with 0.9% normal saline solution without TXA, group B was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery, and group C was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery; then, the same dose was administered again 3 hours later. The assessed outcomes were the operation time, the total blood loss, the hidden blood loss, postoperative drainage, blood transfusions, incidence of venous thromboembolism, and incision infection. RESULTS The total blood loss, the hidden blood loss, and postoperative drainage were the lowest in group C. The amount of intraoperative blood loss was similar among the 3 groups. The hemoglobin and hematocrit values of the third postoperative day were the highest in group C. No significant differences in the incidence of complications and adverse events from TXA use were observed among the 3 groups. The use of TXA, the operation time, and the number of fusion segments were identified as risk factors related to total blood loss. CONCLUSION Two doses of TXA significantly reduced the total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit drop in patients undergoing posterior lumbar fusion without increasing the risk of complications.
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8.
[Clinical study on reconstruction of posterior cruciate ligament with platelet rich plasma combined with 3-strand peroneus longus tendons]
Wu S, Lin W, Xu W, Li H
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2020;34(6):713-719
Abstract
Objective: To investigate the effectiveness of the reconstruction of posterior cruciate ligament (PCL) with platelet rich plasma (PRP) and 3-strand peroneal longus tendons under arthroscope. Methods: Between June 2014 and December 2017, 58 patients with PCL rupture were randomly divided into two groups: the trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone), 29 cases in each group. There was no significant difference in gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score between the two groups (P>0.05). Before operation, at 3 months and 12 months after operation, the IKDC score and Lysholm score of the two groups were recorded to evaluate the knee joint function, AOFAS ankle-hindfoot score was used to evaluate ankle function; KT-2000 examination (knee flexion of 90 degrees , 30 lbs) was used to evaluate the difference of bilateral knee joint posterior relaxation at 12 months after operation, and MRI was used to evaluate ligament reconstruction; CT was used to evaluate the bone tunnel expansion of femur and tibia at 3 months and 12 months after operation. Results: The operation was completed successfully in both groups, there was no complication in the donor tendon area. All the incisions healed by first intention. All the patients were followed up for more than 1 year. The follow-up time of the trial group was 13-17 months, with an average of 15.0 months; that of the control group was 15-20 months, with an average of 15.4 months. At 3 and 12 months after operation, there was no significant difference in AOFAS ankle-hindfoot score when compared with preoperative score and between the two groups ( P>0.05). At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months ( P<0.05); the scores in the trial group were significantly better than those of the control group ( P<0.05). At 12 months after operation, the difference of the posterior relaxation of the bilateral knees in the trial group was less than 5 mm in 27 cases, 6-10 mm in 2 cases; in the control group was less than 5 mm in 20 cases, 6-10 mm in 6 cases, and >10 mm in 3 cases; the difference between the two groups was not significant ( Z=0.606, P=0.544). At 12 months after operation, MRI of knee joint showed that all patients had good PCL graft. The MRI score of the trial group was better than that of the control group ( t=2.425, P=0.019). CT examination at 3 and 12 months after operation showed that the bone tunnel expansion of femur and tibia in the trial group were significantly better than those in the control group ( P<0.05). Conclusion: PRP combined with 3-stand peroneal longus tendons can significantly improve the function and stability of knee joint, effectively promote graft remodeling, and promote tendon bone healing, reduce the expansion of bone tunnel. The effectiveness is satisfactory.
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9.
The efficacy and safety of multiple doses of oral tranexamic acid on blood loss, inflammatory and fibrinolysis response following total knee arthroplasty: A randomized controlled trial
Tang Y, Wen Y, Li W, Li H, Yang Y, Liu Y
International journal of surgery (London, England). 2019;65:45-51
Abstract
BACKGROUND The aim of the study was to identify the efficacy and safety of multiple doses of oral tranexamic acid (TXA) on reducing blood loss and minimizing the postoperative inflammatory and fibrinolytic responses following primary total knee arthroplasty (TKA). MATERIALS AND METHODS In this prospective, double-blinded, randomized trial, we randomly assigned a total of 151 patients into three groups to receive 2g of oral TXA 2h preoperatively (group A); an additional dose of 2g of oral TXA 4h postoperatively (group B); or additional doses of 2g of oral TXA at 4, 10, and 16h postoperatively (group C). The primary outcome was total blood loss (TBL). The secondary outcomes were maximum drop in hemoglobin (Hb) and hematocrit (Hct), level of inflammatory and fibrinolytic parameters, transfusion rate, and the incidence of complications. RESULTS The results were represented as mean+/-standard deviation. The mean TBL was 607+/-254mL in group C, 743+/-347mL in group B (p=0.027 vs group C), and 978+/-335mL in group A (p<0.001 vs group C). The maximum Hb and Hct drop was 18.3+/-7.7g/L and 0.051+/-0.025 in group C, 22.3+/-9.7g/L and 0.070+/-0.028 in group B (p=0.022 and p=0.001 vs group C), 29.6+/-11.7g/L and 0.090+/-0.034 in group A (p<0.001 and p<0.001 vs group C). In addition, C-reactive protein and interleukin-6 in group C were lower than in group A (p<0.001 and p=0.003) and in group B (p=0.031 and p<0.001) on postoperative day (POD) 3. Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on both POD 1 and POD 3. The incidence of complications did not differ significantly between the three groups (p>0.05). CONCLUSION Multiple postoperative doses of oral TXA could further reduced blood loss and the drop in Hb and Hct, and diminished the postoperative inflammatory and fibrinolytic responses in primary TKA with no apparent increase in the incidence of complications. LEVEL OF EVIDENCE Level , therapeutic study.
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10.
Platelet-rich fibrin as an alternative adjunct to tendon-exposed wound healing: A randomized controlled clinical trial
Zhang S, Cao D, Xie J, Li H, Chen Z, Bao Q
Burns : journal of the International Society for Burn Injuries. 2019
Abstract
BACKGROUND The use of platelet-rich fibrin (PRF) has attracted great interest in the treatment of oral and maxillofacial procedures, gingival recessions, and bone healing. However, PRF has been reported hardly to prepare wound bed before skin grafting. This randomized clinical study sought to identify the effect of PRF as an alternative adjunct to tendon-exposed wound healing. METHODS Thirty-six patients with tendon-exposed wounds were treated by applying Integra or PRF (n=18 per group). The take rate of Integra or PRF and pain levels assessed with the four-point verbal rating scale (VRS-4) for the first 5days after application were measured for each condition. Data of texture change analysis were assessed and recorded for a duration of 3 months postoperatively. RESULTS The take rate was less in the Integra group than in the PRF group (92.39 vs 97.83 P<0.001). After surgery, compared to the Integra group, the patients in the PRF group reported significantly lower pain scores (P<0.001). Texture changes from the Integra group were rated higher than those from the PRF (P<0.001). CONCLUSION The use of PRF could be an option for tendon exposed areas where the wound is unfit for standard skin grafting or flap transfer.