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The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSil((R))) Application in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreaticoduodenectomy: A Randomized Clinical Trial
Kwon J, Shin SH, Lee S, Park G, Park Y, Lee SJ, Lee W, Song KB, Hwang DW, Kim SC, et al
World journal of surgery. 2019
Abstract
BACKGROUND Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF. METHODS This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis. RESULTS A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084). CONCLUSIONS Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).
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Use of platelet-rich fibrin in regenerative dentistry: a systematic review
Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, et al
Clinical Oral Investigations. 2017;21((6):):1913-1927
Abstract
OBJECTIVES Research across many fields of medicine now points towards the clinical advantages of combining regenerative procedures with platelet-rich fibrin (PRF). This systematic review aimed to gather the extensive number of articles published to date on PRF in the dental field to better understand the clinical procedures where PRF may be utilized to enhance tissue/bone formation. MATERIALS AND METHODS Manuscripts were searched systematically until May 2016 and separated into the following categories: intrabony and furcation defect regeneration, extraction socket management, sinus lifting procedures, gingival recession treatment, and guided bone regeneration (GBR) including horizontal/vertical bone augmentation procedures. Only human randomized clinical trials were included for assessment. RESULTS In total, 35 articles were selected and divided accordingly (kappa = 0.94). Overall, the use of PRF has been most investigated in periodontology for the treatment of periodontal intrabony defects and gingival recessions where the majority of studies have demonstrated favorable results in soft tissue management and repair. Little to no randomized clinical trials were found for extraction socket management although PRF has been shown to significantly decrease by tenfold dry sockets of third molars. Very little to no data was available directly investigating the effects of PRF on new bone formation in GBR, horizontal/vertical bone augmentation procedures, treatment of peri-implantitis, and sinus lifting procedures. CONCLUSIONS Much investigation now supports the use of PRF for periodontal and soft tissue repair. Despite this, there remains a lack of well-conducted studies demonstrating convincingly the role of PRF during hard tissue bone regeneration. Future human randomized clinical studies evaluating the use of PRF on bone formation thus remain necessary. CLINICAL RELEVANCE PRF was shown to improve soft tissue generation and limit dimensional changes post-extraction, with little available data to date supporting its use in GBR.
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The effect of tranexamic acid used for spine surgery on blood loss and transfused volume Korean
Yoo TJ, Jeon SG, Lee S, Kim K-M, Yon JH, Hong KH
Anesthesia and Pain Medicine. 2009;4((02):):106-112.
Abstract
Background:In this randomized controlled study, we evaluate the effect of tranexamic acid on perioperative blood loss and transfused volume in patients undergoing spine surgery. Methods: We enrolled and randomly allocated 40 patients scheduled for spine surgery under general anesthesia to either tranexamic group or control group.Tranexamic acid was given to tranexamic group with loading dose 10 mg/kg for 15 minutes followed by continuous infusion at the rate of 1 mg/kg/h.In control group, equivalent volume of normal saline was given with the same manner and rate, until the end of procedure. We examined the total blood loss and transfused volume perioperatively. Also we evaluated hemoglobin, platelet, prothrombin time, partial thromboplastin time and thromboelastography before and after surgery. Results: The groups did not differ significantly. Intraoperative blood loss was 1,130.0 ± 563.9 (mean ± SD) ml in control group and 1,061.5 ± 509.7 ml in tranexamic group.Blood loss at postoperative 12 h and 24 h were 392.0 ± 222.0 ml, 466.0 ± 323.2 ml in control group and 158.5 ± 100.6 ml, 470.2 ± 232.7 ml in tranexamic group respectively.Transfused volumes at intraoperative and postoperative period were differing significantly (1,300.0 ± 7 09.3 ml, 800.0 ± 343.3 ml in control group compared to 1,020.0 ± 476.3 ml, 340.0 ± 325.0 ml in tranexamic group). Conclusions: Loading dose of 10 mg/kg tranexamic acid and followed infusion at 1 mg/kg/h reduce perioperative blood trans-fused volume during spinal surgery.
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Efficacy of Crosseal fibrin sealant (human) in rhytidectomy
Lee S, Pham AM, Pryor SG, Tollefson T, Sykes JM
Archives of Facial Plastic Surgery. 2009;11((1):):29-33.
Abstract
OBJECTIVE To examine the potential efficacy of Crosseal (the human protein, bovine component-free fibrin sealant) (OMRIX Biopharmaceuticals, Ltd, Brussels, Belgium) to reduce ecchymoses and hematoma formation in patients undergoing rhytidectomy. METHODS Before initiation of the study, approval was obtained from the US Food and Drug Administration for an Investigational New Drug Application and off-label use of Crosseal and from the Institutional Review Board of the University of California, Davis. Patients undergoing rhytidectomy with or without concomitant procedures were voluntarily enrolled without compensation in the study (N = 9). Patients were randomized according to which side of the rhytidectomy the tissue sealant was placed. In all patients in the study, 1 side of the rhytidectomy was treated with Crosseal; the other, untreated side was used as a control. Before closure of the skin, 2 mL of Crosseal was sprayed through a pressure regulator under the skin flap of the dissected area of the rhytidectomy only on 1 side. The skin was pretrimmed before placement and closed in standard fashion. A pressure dressing was left in place for 3 days before removal. Nine patients were originally enrolled in the study. On postoperative days 3 and 7, photographs were taken of the patients. The photographs were judged by 5 independent reviewers who were blinded as to which side had been treated with Crosseal. The judges rated the degree of ecchymoses on a scale of 1 (minimal) to 10 (severe) and were asked their opinion as to which side of the facelift had been treated with Crosseal. These results were compared using statistical analysis. Also on days 3 and 7, patients were examined for seroma or hematoma formation on each side of the face. RESULTS Our study demonstrated efficacy of Crosseal in reducing ecchymoses and swelling in all patients. The mean score for ecchymosis on the Crosseal-treated side was 4. 5 and on the untreated (control) side was 6. 2 (P < . 01, Wilcoxon rank sum test). The rate of hematoma or seroma formation was 22% (2 of 9 patients) for the untreated side vs 0% (0 of 9 patients) for the treated side. This did not reach statistical significance (P = . 43, Fisher exact test). Small hematomas developed in 2 patients on the control side, which were needle aspirated. There were no known long-term complications from either the use of Crosseal or the rhytidectomy. CONCLUSION Crosseal is efficacious in reducing ecchymoses after rhytidectomy.