Efficacy of Bovine Hydroxyapatite and Collagen Along With Platelet-Rich Fibrin as a Scaffold and Human Chorion as a Membrane for Ridge Preservation: A Case-Control Study
AIM: The present study aims to determine the efficacy of bovine hydroxyapatite and collagen (G-graft) mixed with platelet-rich fibrin (PRF) used as a scaffold and chorion membrane as a barrier in post-extraction sockets with extraction sites alone. METHODS AND MATERIAL Thirty individuals were randomly assigned into two groups. In the control group, after debridement of the extracted tooth socket, no additional treatment was done. In the test group, after debridement of the extracted tooth socket, the sockets were filled with bovine hydroxyapatite and collagen (G-graft) mixed with PRF. They were covered by a chorion membrane, and a non-absorbable suture material was used to secure the membrane in place. Clinical parameters assessed were plaque index, gingival index, buccolingual width, buccal bone plate height, and lingual bone plate height at baseline and at six months. RESULTS Clinically, there was a more significant reduction in the buccolingual width of the control group than the test group after six months. A statistically significant difference between the two groups for vertical ridge height at the mesial and distal socket sites was observed. No statistically significant difference in buccal and lingual bone plate height was observed between the two groups (p>0.05). CONCLUSIONS Both groups showed a significant reduction in the Buccolingual width, but it was less in the ridge preservation group. Thus, the use of G-graft with PRF and chorion membrane was highly effective in ridge preservation. Key messages: Natural bovine bone mineral, along with PRF and chorion as a membrane, can be utilized effectively for ridge preservation in extracted tooth sockets due to periodontal disease.
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.
Comparison of Laparoscopic Sleeve Gastrectomy Bleeding and Leakage Rates in Four Staple-Line Reinforcement Methods: A Prospective Observational Study
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2022
Introduction: Staple-line bleeding and gastric leakage are the most serious complications of laparoscopic sleeve gastrectomy (LSG). Reinforcement of the staple line is reported to be a method to reduce these complications rates, but the question of which method is preferable is a matter of controversy in the literature. In this study, we compared different staple-line reinforcement methods to assess their efficiency in preventing staple-line bleeding and leakage. Materials and Methods: Two hundred patients eligible for LSG were enrolled in the study and randomized into five groups based on the reinforcement method used during surgery: no reinforcement, oversewing using 3-0 polydioxanone (PDS) suture, oversewing using 4-0 barbed absorbable closure device (V-Lock), fibrin sealant glue, and buttress material. Intraoperative and postoperative complications were recorded and analyzed. Differences were considered statistically significant for P < .05. Results: The no-reinforcement group showed higher bleeding rates (20%), although only 2.5% of the patients required reintervention. All groups using staple-line reinforcement showed better outcomes in bleeding rates (P < .05). No statistically significant differences were observed among the groups in terms of the leakage rate, reintervention rate, intraoperative complications, and operative times. Conclusion: The reinforcement of the staple line decreased the bleeding rate in sleeve gastrectomy but did not affect the gastric leakage rate.
Gas Tamponade for the Prevention of Postoperative Vitreous Hemorrhaging after Diabetic Vitrectomy: a Randomized Clinical Trial: Gas versus Fluid after Diabetic Vitrectomy
American journal of ophthalmology. 2022
PURPOSE To compare vitreous substitution with sulfur hexafluoride (SF6) gas to balanced salt solution (BSS) for the prevention of postoperative vitreous hemorrhage (VH) in proliferative diabetic retinopathy (PDR) patients undergoing pars plana vitrectomy (PPV) for the indication of non-clearing VH. METHODS One hundred and forty-four PDR subjects requiring PPV for the indication of non-clearing VH were enrolled into the trial. Subjects were prospectively randomized into one of two vitreous substitution groups: Group A subjects underwent 20-30% SF6 gas tamponade, whereas Group B subjects underwent vitreous substitution with BSS. The primary outcome was the incidence of postoperative VH during the 6-month trial period. Secondary outcomes were unplanned PPV for VH and best-corrected visual acuity (BCVA) at 6-months follow-up. RESULTS Ninety six subjects underwent randomization and completed 6-months follow-up. The incidence of postoperative VH during the trial period was 11.1% (6/54) in Group A (SF6) and 33.3% (14/42) in Group B (BSS) (P=.01). The incidence of unplanned PPV during the trial period for postoperative VH was 3.7% (2/54) in Group A (SF6) and 14.2% (6/42) in Group B (BSS) (P=.06). The mean BCVA was not significantly different at 6-months follow-up between groups (P=.58). CONCLUSIONS This trial indicates that vitreous substitution with SF6 gas lowers the incidence of postoperative VH compared to BSS in PDR subjects undergoing PPV for the indication of non-clearing VH at 6-months follow-up. Specialists may consider SF6 gas tamponade during PPV as a means to help reduce postoperative VH in this patient population.
Perioperative intravenous iron to treat patients with fractured hip surgery: A systematic review and meta-analysis
Health science reports. 2022;5(3):e633
BACKGROUND Treatment of preoperative anemia with intravenous iron is common within elective surgical care pathways. It is plausible that this treatment may improve care for people with hip fractures many of whom are anemic because of pre-existing conditions, fractures, and surgery. OBJECTIVE To review the evidence for intravenous iron administration on outcomes after hip fracture. DESIGN We followed a predefined protocol and conducted a systematic review and meta-analysis of the use of intravenous iron to treat anemia before and after emergency hip fracture surgery. The planned primary outcome was a difference in length of stay between those treated with intravenous iron and the control group. Other outcomes analyzed were 30-day mortality, requirement for blood transfusion, changes in quality of life, and hemoglobin concentration on discharge from the hospital. DATA SOURCES EMBASE, MEDLINE, The Cochrane Library (CENTRAL, DARE) databases, Clinicaltrials.gov, and ISRCTN trial registries. Date of final search March 2022. ELIGIBILITY CRITERIA Adult patients undergoing urgent surgery for hip fracture. Studies considered patients who received intravenous iron and were compared with a control group. RESULTS Four randomized controlled trials (RCT, 732 patients) and nine cohort studies (2986 patients) were included. The RCTs were at low risk of bias, and the nonrandomized studies were at moderate risk of bias. After metanalysis of the RCTs there was no significant difference in the primary outcome, length of hospital stay, between the control group and patients receiving intravenous iron (mean difference: -0.59, 95% confidence interval [CI]; -1.20 to 0.03; I (2) = 30%, p = 0.23). Intravenous iron was not associated with a difference in 30-day mortality (n = 732, OR: 1.14, 95% CI: 0.62-2.1; I (2) = 0%, p = 0.50), nor with the requirement for transfusion (n = 732, OR: 0.85, 95% CI: 0.63-1.14; I (2) = 0%, p < 0.01) in the analyzed RCTs. Functional outcomes and quality of life were variably reported in three studies. CONCLUSION The evidence on the use of intravenous iron in patients with hip fracture is low quality and shows no difference in length of acute hospital stay and transfusion requirements in this population. Improved large, multicentre, high-quality studies with patient-centered outcomes will be required to evaluate the clinical and cost-effectiveness of this treatment.
Safety and efficacy of Ninjin'yoeito along with iron supplementation therapy for preoperative anemia, fatigue, and anxiety in patients with gynecological disease: an open-label, single-center, randomized phase-II trial
BMC women's health. 2022;22(1):229
BACKGROUND Preoperative anemia affects perioperative outcomes and often causes fatigue and psychological disorders. Therefore, anemia should be treated before a patient undergoes surgery. Ninjin'yoeito (NYT), a Japanese Kampo medicine composed of ginseng and Japanese angelica root with the other 10 herbs, is administered for anemia, fatigue and anxiety; however, there are a few reports that have prospectively examined the effects of NYT before surgery for gynecological diseases. Hence, we tended to investigate its efficacy and safety. METHODS In this open-label randomized trial, women with gynecological diseases accompanied by preoperative anemia (defined as < 11.0 g/dL Hemoglobin [Hb]) were randomly assigned (1:1) into the iron supplementation and NYT groups. Patients of the iron supplementation group and the NYT group received 100 mg/day iron supplementation with and without NYT (7.5 g/day) for at least 10 days before surgery. The primary endpoint was improvement in Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores between groups. Statistical analyses were performed with Wilcoxon signed rank test, Wilcoxon rank sum test, and Fisher's exact test as appropriate. RESULTS Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group. There was no difference in the characteristics between both groups. Hb significantly increased in both groups (iron supplementation group, 9.9 ± 0.8 g/dL vs. 11.9 ± 1.6 g/dL; NYT group, 9.8 ± 1.0 g/dL vs. 12.0 ± 1.0 g/dL); the difference in the elevations in Hb between both groups was statistically insignificant (P = 0.72). Contrarily, CFS (17.9 ± 10.2 vs. 8.1 ± 5.2) and VAS-A (56 mm (50-70) vs. 23 mm (6-48)) scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014). Liver dysfunction occurred in one patient of the NYT group. CONCLUSIONS For treating preoperative anemia in women with gynecological conditions, NYT administration along with iron supplementation safely and efficiently improved the preoperative fatigue and anxiety in addition to the recovery from anemia. TRIAL REGISTRATION jRCT1051190012 (28/April/2019, retrospectively registered).
Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials
Obstetrics & gynecology science. 2022
To perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated the efficacy and safety of prophylactic tranexamic acid (TXA) versus a control (placebo or no treatment) during hysterectomy for benign conditions. Six databases were screened from inception to January 23, 2022. Eligible studies were assessed for risk of bias. Outcomes were summarized as weighted mean differences and risk ratios with 95% confidence intervals in a random-effects model. Five studies, comprising six arms and 911 patients were included in the study. Two and three studies had an overall unclear and low risk of bias, respectively. Estimated intraoperative blood loss, requirement for postoperative blood transfusion, and requirement for intraoperative topical hemostatic agents were significantly reduced in a prophylactic TXA group when compared with a control group. Moreover, postoperative hemoglobin level was significantly higher in the prophylactic TXA group than in the control group. Conversely, the frequency of self-limiting nausea and vomiting was significantly higher in the prophylactic TXA group than in the control group. There were no significant differences between the groups in terms of surgery duration, hospital stay, and diarrhea rate. All the RCTs reported no incidence of major adverse events in either group, such as mortality, thromboembolic events, visual disturbances, or seizures. There was no publication bias for any outcome, and leave-one-out sensitivity analyses demonstrated stability of the findings. Among patients who underwent hysterectomy for benign conditions, prophylactic TXA appeared largely safe and correlated with substantial reductions in estimated intraoperative blood loss and related morbidities.
The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients
Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie. 2022;49(2):98-105
BACKGROUND Observational studies suggest that sex-mismatched transfusion is associated with increased mortality. Mechanisms driving mortality are not known but may include endothelial activation. The aim of this study is to investigate the effects of sex-mismatched red blood cell (RBC) transfusions on endothelial cell activation markers in critically ill patients. STUDY DESIGN AND METHODS In patients admitted to the intensive care unit who received a single RBC unit, blood samples were drawn before (T(0)), 1 h after (T(1)), and 24 h after transfusion (T(24)) for analysis of soluble syndecan-1, soluble intercellular adhesion molecule-1, soluble thrombomodulin (sTM), von Willebrand factor antigen, interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNFα). Changes in the levels of these factors were compared between sex-matched and sex-mismatched groups. RESULTS Of 69 included patients, 32 patients were in the sex-matched and 37 patients were in the sex-mismatched group. Compared to baseline, sex-matched transfusion was associated with significant reduction in sTM level (p value = 0.03). Between-group comparison showed that levels of syndecan-1 and sTM were significantly higher in the sex-mismatched group compared to the sex-matched group at T(24) (p value = 0.04 and 0.01, respectively). Also, TNFα and IL-6 levels showed a statistically marginal significant increase compared to baseline in the sex-mismatched group at T(24) (p value = 0.06 and 0.05, respectively), but not in the sex-matched group. DISCUSSION Transfusion of a single sex-mismatched RBC unit was associated with higher syndecan-1 and sTM levels compared to transfusion of sex-matched RBC unit. These findings may suggest that sex-mismatched RBC transfusion is associated with endothelial activation.
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.
The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.