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300 result(s) for "Gelatin Sponge, Absorbable"
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A cost-effective measure to prevent hemorrhage in ultrasound-guided percutaneous liver biopsy
Background Liver biopsy is a procedure whereby a biopsy needle is used to extract tissue from the liver parenchyma or focal lesions of the liver for pathological or microbiological examination. Percutaneous liver biopsy(PC-LB) is the most commonly employed and least expensive modality. However, it is associated with a significant risk of bleeding complications, which may potentially result in patient mortality. The objective of this study was to investigate the efficacy of Absorbable Gelatin Sponge sheet filler agent (AGS-SFA) in preventing bleeding complications during liver tissue biopsy and to validate a cost-effective surgical technique. Methods In this study, patients who underwent ultrasound-guided percutaneous liver tissue biopsy at our hospital were selected and randomly assigned to either an observation or control group. The observation group employed the use of AGS-SFA to fill the biopsy needle channel. Immediately following the biopsy procedure, the biopsy needle path was examined using Doppler ultrasound. The incidence of bleeding complications following biopsy and the associated factors influencing bleeding were analysed in the two groups. Results The observation and control groups were successfully biopsied, with a 100% success rate for both. The incidence of bleeding complications was significantly lower in the observation group than in the control group. Four factors, including fatty liver, prothrombin time, albumin and INR, were found to have a significant effect on biopsy bleeding in the control group. Conclusion The use of coaxial needles to inject AGS-SFA is an effective and economical procedure that significantly improves the safety of biopsy without increasing the burden of patient care.
Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
Background. The efficacy of a thrombin-based hemostatic agent (Floseal®) on reducing postoperative blood loss after total knee arthroplasty (TKA) was still unclear. The aim of our study was to conduct a prospective randomized controlled study to compare the blood conservation effects of Floseal® and topical TXA in patients with preexisting thromboembolic risk undergoing primary minimally invasive TKA. Methods. Our power analysis of this study was based upon the following description, to obtain a statistical power of 0.90 and an alpha error of 0.05, 30 patients were required in each group. Therefore, we enrolled a total of 103 patients with at least one of the risk factors for thromboembolism who underwent unilateral primary minimally invasive TKA, and the participants were randomly divided into the topical TXA group (n=34), receiving intra-articular injection of 3 g of TXA in 100 mL saline after TKA, the topical Floseal® group (n=34), receiving 10 mL of Floseal® intra-articularily during surgery, and the placebo group (n=35), receiving an intra-articular saline injection only. The total blood loss (TBL) and hemoglobin (Hb) drop were compared among the 3 groups. Results. The TXA group had a lower TBL of 645 mL (227 to 1090) in comparison with 1145 mL (535 to 1942) in the Floseal® group and 1103 mL (424 to 1711) in the placebo (p<0.001, respectively). The TBL was similar between the Floseal® group and the placebo group (p=0.819). No patients in any group had symptoms of venous thromboemblism. Conclusion. Our prospective randomized controlled study showed that intra-articular application of TXA was superior to hemostatic matrix (Floseal®) in terms of blood conservation in patients with preexisting thromboembolic risk undergoing minimally invasive TKA. This trial is registered with Clinicaltrials.gov (NCT02865174) on 08/09/2016.
The effects of chlorhexidine gel and tranexamic acid application after tooth extraction on the risk of alveolar osteitis formation: a double blind clinical study
Background Alveolar osteitis(AO), one of the most common complications occurring in 1–10% of cases following tooth extraction, occurs due to the disruption of clot formation in the extraction socket. This study aims to evaluate the effect of using absorbable gelatin sponge, chlorhexidine gel, and tranexamic acid agents on the development of AO following extraction. Methods Between March and October 2023, the teeth of 98 healthy patients (average age: 38, range: 19–62) with extraction indications were extracted at Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery. 113 extraction sockets(85 molars and 28 premolars) were randomly treated with absorbable gelatin sponge(AGS), chlorhexidine gel with AGS, and tranexamic acid with AGS. Pain and edema levels were recorded using visual analog scale(VAS) ranging from 0 to 10 by the patients. Additionally, presence of halitosis, trismus and exposed bone was noted on forms on 3rd and 7th days (recorded as present or absent). The study prospectively aimed to prevent AO using 3 different dental agents in the extraction sockets. Statistical analyses of the study were conducted using the SPSS software package. Results Alveolitis was observed in 12 out of 113 tooth extractions(%10.6). Pain and edema scores significantly decreased in absorbable gelatin sponge group on the 7th day ( p  < 0.05). Pain score on the 7th day in chlorhexidine group and age, edema score on the 7th day in tranexamic acid group, were found to be significantly higher ( p  < 0.05). Conclusion Incidence of AO, can be reduced by placing agents in the extraction socket, preventing post-extraction pain experienced by patients. Clinical trials ID NCT06435832.
Using tranexamic acid soaked absorbable gelatin sponge following complex posterior lumbar spine surgery: A randomized control trial
•A prospective randomized control trail for the use of TXA-soaked Gelfoam in spine surgery was reported.•TXA-soaked Gelfoam could more effectively reduce post-operative blood loss and blood transfusions.•TXA-soaked Gelfoam could lead to significant cost savings. This paper aims to determine whether the use of Tranexemic Acid (TXA) – soaked absorbable gelatin sponge could more effectively reduce post-operative blood loss and blood transfusion requirements among low-risk adult patients undergoing lumbar spine surgery. A total of 90 consecutive patients undergoing surgery for multilevel posterior lumbar degenerative procedures were prospectively randomized into one of three groups: – TXA Soaked Gelfoam group, absorbable gelatin sponge group or control group. Demographic distribution, total drain output, blood transfusion requirement, length of hospital stay, the number of readmissions, and postoperative complications were analyzed. In the TXA Soaked Gelfoam, Gelfoam, and control groups, the respective hemovac drainage at the first 8h postoperatively was 81.06±61.21, 166.73±76.76, and 155.67±92.94ml respectively. The second 8h period drainage for the same groups postoperatively was 46.67±40.09, 55.10±43.43, and 82.50±56.67ml and 23.73±25.56, 32.43±25.81 and 44.20±32.44ml for the third 8h period postoperatively. The duration of the post-operative drain left in the TXA Soaked Gelfoam group was significantly shorter than the Gelfoam and control groups (p=0.019 and 0.000, respectively). The TXA Soaked Gelfoam and Gelfoam also had a significantly shorter hospital stay than the control group (p=0.014, and 0.036, respectively). No patient developed adverse reactions attributable to the tranexamic acid soaked absorbable gelatin sponge. TXA-soaked absorbable gelatin sponge is a safe, effective treatment for reduction of post-operative blood loss and blood transfusions among low-risk adult patients undergoing lumbar spine surgery.
Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial
Background Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis. Methods A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed. Results There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p  = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p  = 1.000), requirement for admission (15.4% vs. 46.1%, p  = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p  = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p  = 0.0022), treatment (0.50 vs. 4.46, p  = 0.0007) and removal (0 vs. 3.85, p  = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment. Conclusions Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile. Trial registration Trial registration number: NCT02488135 . Date registered: June 26, 2015.
Use of Fluid Gelatin in Lumbar Spinal Stenosis Undergoing Unilateral Biportal Endoscopic: A Prospective, Randomized Controlled Trial
Objectives In patients with lumbar spinal stenosis (LSS) undergoing unilateral biportal endoscopic unilateral laminotomy for bilateral decompression (UBE‐ULBD), damage to the epidural venous plexus often leads to bleeding, increasing the risk of surgical complications. Surgiflo Hemostatic Matrix (SHM) is a gelatin extracted from porcine skin, used for intraoperative hemostasis. This study aims to evaluate the effectiveness and safety of using SHM during UBE‐ULBD surgery. Methods From October 2023 to July 2024, a total of 96 patients with LSS underwent UBE‐ULBD surgery. These 96 patients were randomly divided into two groups: the SHM group (48 patients, using flowable gelatin) and the non‐SHM group (48 patients, not using flowable gelatin). The primary outcomes included intraoperative blood loss, postoperative drainage volume, and the 3‐min hemostasis success rate. Secondary outcomes included symptomatic postoperative epidural hematoma (SPEH), surgical time, postoperative hospital stay, hospitalization costs, and complications. We used independent sample t‐tests to compare continuous data, and chi‐square tests or Fisher's exact tests to analyze categorical data. Results The intraoperative blood loss and postoperative drainage volume in the SHM group were significantly less than those in the non‐SHM group (p < 0.05), and the 3‐min hemostasis success rate in the SHM group was significantly higher than that in the non‐SHM group (p < 0.05). There were no statistically significant differences between the two groups regarding SPEH, postoperative hospital stay, hospitalization costs, and complications such as thrombosis formation and allergic reactions. However, the surgical time in the SHM group was significantly shorter than that in the non‐SHM group (p < 0.05). Conclusion When patients with LSS undergo UBE‐ULBD, the use of fluid gelatin can effectively reduce intraoperative and postoperative bleeding without introducing additional complications. The 96 patients were randomly assigned to two groups: the Surgiflo Hemostatic Matrix (SHM) group and the non‐SHM group. The use of fluid gelatin effectively reduces intraoperative and postoperative bleeding without leading to additional complications.
Endoscopic push-through technique compared to microscopic underlay myringoplasty in anterior tympanic membrane perforations
Microscopic myringoplasty is the most frequently performed procedure for repairing tympanic membrane perforations. The endoscopic transcanal approach bypasses the narrow ear canal segment and provides a wider view. An open-label randomised clinical trial was conducted on 56 patients with small anterior tympanic membrane perforations. Perforations were repaired with an endoscopic push-through technique (n = 28) or a microscopic underlay technique (n = 28). Follow up was conducted using endoscopic examination and pure tone audiometry three months' post-operatively. Graft success rate was 92.9 per cent in the endoscopic group versus 85.7 per cent in the microscopic group. The corresponding pre-operative mean air-bone gaps were 17.4 dB and 18.5 dB, improving to 6.1 dB and 9.3 dB post-operatively (p > 0.05). Mean air-bone gap closure was 11.4 dB in the endoscopic group and 9.2 dB in the microscopic group (p > 0.05). Mean operative time and estimated blood loss were 37.0 minutes and 29 ml in the endoscopic group, versus 107 minutes and 153 ml in the microscopic group (both p < 0.05). The endoscopic push-through technique for anterior tympanic membrane perforations is as effective as microscopic underlay myringoplasty; furthermore, it is less invasive and takes less operative time.
Efficacy of topical tranexamic acid soaked absorbable gelfoam in relieving post-extraction pain in warfarin patients: a randomized, triple-blinded, split-mouth, active-controlled clinical trial
Background Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients. Methods This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel ( n  = 30). Group 2: TXA-Gel ( n  = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t 0 ), and on the 1st (t 1 ), 2nd (t 2 ), 3rd (t 3 ), 4th (t 4 ), 5th (t 5 ), 6th (t 6 ), and 7th (t 7 ) days following extraction. The Kolmogorov–Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 ( p  < 0.05). Results The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 ( p  = 0.236) and t2 ( p  = 0.155). However, there was a statistically significance difference at the rest time points ( p  < 0.05). Conclusions TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients. Trial registration The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).
Guidelines on the use of gelatin sponge particles in embolotherapy
Gelatin sponge (GS) is one of the most widely used embolic agents in interventional procedures. There are four commercially available GS products in Japan; however, the endovascular use of Gelfoam and Spongel is off-label, and Gelpart can only be used for hepatic artery embolization and Serescue can only be used for hemostasis of arterial bleeding. GS has been used for a variety of clinical indications, mainly tumor embolization and stopping massive arterial bleeding. The optimal size and preparation procedure of GS particles differs slightly for each clinical indication. In addition, there is a risk of ischemic and/or infectious complications associated with GS embolization in various situations. Therefore, radiologists should be familiar with not only the preparation and handling of GS particles, but also the disadvantages and potential risks, in order to perform GS embolization safely and effectively.
Transcatheter Arterial Embolization for Primary Postpartum Hemorrhage: Predictive Factors of Need for Embolic Material Conversion of Gelatin Sponge Particles to N-Butyl Cyanoacrylate
Purpose To identify predictive factors for embolic material conversion to N -butyl cyanoacrylate (NBCA) for the treatment of primary postpartum hemorrhage (PPH) after failed transcatheter arterial embolization (TAE) using gelatin sponge (GS). Materials and Methods Institutional review board approval was obtained. We retrospectively studied 62 consecutive women with primary PPH who underwent TAE between January 2006 and March 2015. Five of them were excluded for the following: cardiopulmonary arrest at arrival ( n =  1), uterine inversion ( n =  1), and hysterectomy after TAE ( n =  3). Remaining 57 women (age range, 21–43 years; mean, 32.6 years) comprised study population. TAE was initially performed using GS in all cases and then converted to NBCA after two embolizations using GS with persistent hemodynamic instability or vaginal bleeding. The patients’ background, uterine height, vital signs, laboratory tests, disseminated intravascular coagulation score, and details of procedure were reviewed. Univariate and multivariate analyses were performed to determine factors related to embolic material conversion. Results Technical success rate was 100%. Fourteen patients (25%) needed embolic material conversion to NBCA. Univariate analysis showed that uterine height, systolic blood pressure (sBP), and hemoglobin level were significantly related to embolic material conversion to NBCA ( P  = 0.029, 0.030, and 0.042). Logistic regression analysis showed that uterine height (odds ratio, 1.37; P  = 0.025) and sBP (odds ratio, 0.96; P  = 0.003) were associated with embolic material conversion to NBCA. Conclusion Uterine height and sBP can be predictive factors for embolic material conversion to NBCA for the treatment of PPH. Level of Evidence Level 4, Case Control Study