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 (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) 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).

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 Erdogan 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.

A Novel Nasal Endoscopy-Assisted Method for Sealing Cerebrospinal Fluid Rhinorrhea.

Cerebrospinal fluid (CSF) rhinorrhea is one of the most common complications after trans-sphenoidal surgery. At present, transcranial or endoscopic surgery for CSF leakage requires general anesthesia to remove autologous fat or fascia to repair the leak, which is traumatic and costly. The authors present a case of a 25-year-old male patient with pituitary adenoma who experienced CSF rhinorrhea 10 days after undergoing endoscopic resection of the tumor. The authors innovatively sequential filled the leak with a gelatin sponge soaked in povidone-iodine solution and iodinated gauze under outpatient nasal endoscopy. The follow-up of 6 months showed no recurrence of CSF leakage. CSF leakage is the most common complication of trans-sphenoidal surgery. The authors suggest that for small cerebrospinal fluid leaks in the early stage after trans-sphenoidal surgery, the leakage should be first filled with gelatin sponge and iodoform gauze sequentially under outpatient nasal endoscopy, which may achieve a complete cure.

Repairing Exposed Tendon Wounds with Absorbable Gelatin Sponges and Autologous Split-Thickness Skin Grafts: A Case Series.

ABSTRACT: Conventional flap repair surgery has several drawbacks, including operational complexity, donor site damage, and high risk. In this case series, the authors explored an alternative approach for repairing exposed tendon wounds caused by trauma using absorbable gelatin sponges (AGSs) and autologous thigh skin grafts. This report presents two cases of lower-extremity skin necrosis with tendon exposure following wound debridement. The treatment approach involved early debridement, negative-pressure wound therapy, and wound irrigation with 0.9% sodium chloride. Upon achieving controlled wound infection, AGSs were applied to the exposed tendon to prevent degeneration and promote wound healing. Subsequently, areas where granulation tissue failed to cover the tendon were repaired using AGSs and 0.25-mm-thick autologous mesh skin grafts harvested from the thigh. Complete wound healing was achieved in both cases, on the 20th and 12th day after skin grafting, respectively. The proposed method proved successful in repairing exposed tendon wounds, effectively preventing infection and necrosis.

Enhanced technique of dural closure using autologous fat graft and Gelfoam for effective management of dural tear following interlaminar endoscopic lumbar spine surgery.

BACKGROUND: Incidental dural tears are common complications in lumbar spine surgery, particularly in endoscopic procedures where primary closure via suturing is challenging. The absence of a standardized approach for dural closure in endoscopic spine surgery necessitates exploring alternative techniques. OBJECTIVE: This study introduces a surgical technique for dural closure utilizing fat graft and Gelfoam, offering an effective alternative to standard approaches in endoscopic spine surgery. METHODS: Surgical data from patients who underwent interlaminar endoscopic discectomy or stenosis decompression at Lerdsin Hospital from October 2014 to October 2021 were analyzed. RESULTS: Among 393 cases, dural tears occurred in 2% (8 patients). Our technique achieved successful closure in all these cases, with no incidents of cerebrospinal fluid leakage or wound complications. The majority of patients showed favorable clinical outcomes, except for one case involving concomitant nerve root injury. CONCLUSION: This study demonstrates that using fat graft and Gelfoam for dural closure is a simple, reliable, and safe technique, particularly effective for challenging-to-repair areas in interlaminar endoscopic lumbar spine surgery.

Transcatheter Arterial Embolization with Bleomycin-Lipiodol of Hepatic Hemangiomas: Safety, Efficacy and Predictors of Response.

PURPOSE: To evaluate the safety, efficacy and predictors of response of transcatheter arterial embolization (TAE) to treat hepatic hemangiomas (HHs). MATERIALS AND METHODS: A retrospective analysis was conducted of consecutive HH patients who received TAE with bleomycin-Lipiodol emulsion and gelatin sponge particles at three institutions from January 2014 to January 2021. TAE effectiveness was defined as more than 50% reduction of tumor volume. The effectiveness, safety, and CT changes of hemangiomas after TAE were assessed. Factors affecting TAE efficacy on tumor size were analyzed with logistic regression analysis. RESULTS: A total of 102 patients with 109 HHs were included. After treatment, both the tumor diameter and volume were significantly reduced from 8.5 ± 3.9 to 5.9 ± 3.8 cm (P < 0.001) and 412.6 ± 742.3 cm3 to 102.0 ± 232.7 cm3 (P < 0.001), respectively. TAE effectiveness was achieved in 80.7% (88/109) of hemangiomas, which was characterized by progressive reduction in tumor volume over time with Lipiodol retention. Atypical enhancement pattern (tiny enhancing dots in the hepatic arterial and portal venous phase) (p = 0.001) and central arterioportal shunt (APS) (p = 0.002) associated with the tumor were independent predictors of TAE ineffectiveness. Postembolization syndrome and transient increase in liver enzymes were common without severe complications and death. CONCLUSION: TAE was safe and effective in reducing HH size. Lesion enhancement pattern and APS type were associated with TAE efficacy on tumor shrinkage. LEVEL OF EVIDENCE: Level 3, non-controlled retrospective cohort study.

Effectiveness of a thrombin-gelatin flowable for treating severe liver bleeding: an experimental study.

BACKGROUND: Current scientific evidence has pointed out the relevance of hemostatic products for improving clinical outcomes in liver trauma, including increased survival rates and reductions in bleeding-related complications. The purpose of this study was to compare the use of the gelatin-thrombin flowable (Flowable) versus the standard technique of Packing in a new experimental liver injury model. METHODS: Twenty-four swine were prospectively randomized to receive either Flowable or standard packing technique. We used a novel severe liver injury model, in which the middle and left suprahepatic veins were selectively injured, causing an exsanguinating hemorrhage. The main outcome measure was the percentage of lost blood volume. RESULTS: The median total percentage of total blood volume per animal lost, from injury to minute 120, was significantly lower in the Flowable group (15.2%; interquartile range: 10.7-46.7%) than in the Packing group (64.9%; Interquartile range: 53.4-73.0%) (Hodges-Lehmann median difference: 41.1%; 95% CI: 18.9-58.0%, p = 0.0034). The 24-hour survival rate was significantly higher in the Flowable group (87.0%) than in the Packing group (0.0%) (Hazard ratio (HR) 0.08; 95% confidence interval 0.102 to 0.27; p < 0.0001). Mean-arterial pressure was significantly lower at minute 60 and 120 in the Flowable group than in the packing group (p = 0.0258 and p = 0.0272, respectively). At minute 120, hematocrit was higher in the Flowable than in the packing group (Hodges-Lehmann median difference: 5.5%; 95%CI: 1.0 to11.0, p = 0.0267). Finally, the overall-surgical-procedure was significantly shorter with Flowable than with Packing (Hodges-Lehmann median difference: 39.5 s, 95% CI: 25.0 to 54.0 s, p = 0.0004). CONCLUSIONS: The use of the Flowable was more effective in achieving hemostasis, reducing blood loss, and improving survival rates than standard packing in a severe porcine-liver bleeding model.

Let us settle the controversy-gelfoam is a safe intravascular embolic agent.

OBJECTIVES: A 2021 safety alert restricted endovascular gelfoam use in Australia and resulted in an embargo on gelfoam sales to Interventional Radiology departments. This study aimed to show that gelfoam is safe in a population of trauma patients with pelvic injury, and discuss the basis of the recent controversies. METHODS: Retrospective cohort study was conducted between 1 January 2010 and 21 May 2021 for the patients who underwent gelfoam embolization for pelvic arterial haemorrhage. Primary outcome was the rate of adverse events related to intravascular gelfoam administration. RESULTS: Inclusion criteria met in 50 patients, comprising 58% males median age 59.9 years, and median injury severity score 31. There were 0 complications related to gelfoam use and 100% technical success. Thirty-five patients (70%) received a non-targeted embolization approach. All-cause mortality was observed in 5 patients (10%), unrelated to gelfoam. CONCLUSIONS: Gelfoam is a safe and effective embolic agent in pelvic trauma. Patients are in urgent need of universal on-label registration of endovascular gelfoam products, as it is life-saving in major haemorrhage after trauma. ADVANCES IN KNOWLEDGE: Endovascular gelfoam is mandatory for a high-quality trauma service, and this study shows that it is safe to use intentionally in the endovascular space. Companies should work with interventional radiologists, sharing and collaborating to ensure positive outcomes for patients.

The Efficacy of BloodSTOP iX, Surgicel, and Gelfoam in Vascular Operations: First-in-Human Head-to-Head Study.

This study aims to compare the efficacy and safety of 3 different hemostatic agents in vascular surgeries in humans. Twenty-four patients were enrolled in the present study with 40 vascular anastomoses including 16 aortic and 24 femoral. The patients were randomized (computer-based) to either BloodSTOP iX, Gelfoam, or Surgicel. The hemostatic agent was applied at the site of the vascular anastomosis before declamping. The site of anastomosis was then observed for bleeding from the suture line for 2 min. If any bleeding was detected, blood was then collected for 5 min, and the time needed to stop bleeding was measured. A suction drain was fixed in the surgical bed to collect serous fluid postoperatively more than 48 h afterward. The volume of blood collected in 5 min was significantly lower in the BloodSTOP group compared with the other 2 hemostatics. There was a significant reduction in the mean time needed to stop bleeding from the anastomotic surface in the BloodSTOP group compared with the Surgicel and Gelfoam groups. In addition, Surgicel showed the highest rate of complication (46.2%) compared with BloodSTOP (7%). BloodSTOP iX dramatically reduced bleeding volume and time compared with the other hemostatic agents. Furthermore, it showed a lower complication rate and did not interfere with the healing process at the application sites.

Safety and Efficacy Comparison of Embospheres and Gelfoam Particles in Bronchial Artery Embolization for Massive Hemoptysis.

Objective: The objective of this research study was to compare the safety and efficacy of bronchial artery embolization (BAE) using Embospheres alone versus Embospheres combined with gelfoam particles in patients with massive hemoptysis. Methods: A total of 127 patients with tuberculous massive hemoptysis who were scheduled to undergo BAE were recruited and divided into two groups: Embosphere group (E group, n = 57) and Embosphere combined with gelfoam particles group (E + G group, n = 70). Technical and clinical success were assessed after BAE surgery, and mortality, untoward reactions, and risk factors for clinical failure were recorded during follow-up. Results: The technical success rate was 92.99% in the E group and 97.14% in the E + G group (P = .272), with similar 1-year mortality rates of 1.76% and 2.86%, respectively (P = .684). However, the E group exhibited a lower clinical success rate compared to the E + G group (85.96% vs. 97.14%), and this difference was statistically significant (P = .020). The untoward reactions showed no statistically significant difference (all P > .05). Univariate analysis revealed that four factors were statistically significant: age (P = .028), presence of pulmonary cavity (P = .001), diabetes (P = .005), and a single use of Embosphere embolization (P = .020). Multivariate regression analysis demonstrated that embolization with Embosphere alone was a risk factor for clinical treatment failure (P = .025). Conclusion: The combination of Embosphere with gelfoam particles can significantly improve the hemostatic effect of BAE without increasing the incidence of adverse reactions.

Management of acute intra-abdominal hemorrhage in ruptured hepatoblastoma with transarterial embolization using calibrated gelfoam particles.

This brief report aims to evaluate the treatment outcome of transarterial embolization in ruptured hepatoblastoma complicated with acute intra-abdominal hemorrhage. Three children (mean age 6 years) with high-risk hepatoblastoma presented with rupture and acute intra-abdominal hemorrhage. In addition to aggressive fluid resuscitation and blood product support, super-selective embolization of the arteries with active bleeding or pseudoaneurysm was performed using calibrated gelfoam particles, with a technical success rate of 100%. Hemodynamic status and hemoglobin level were normalized in all patients within 2 days postembolization. The 30-day survival rate was 100%. No major complication was detected apart from mild elevation of alanine transaminase.

Super-selective Gelfoam embolisation in high-flow priapism.

INTRODUCTION: High-flow priapism is a rare condition with limited data in the literature, particularly in Australia. There is therefore no clear consensus regarding treatment. We aim to present our institutional network experience in managing this condition over the last decade with super-selective gelatin sponge (Gelfoam) embolisation of the internal pudendal artery. METHODS: We retrospectively searched for and reviewed the patient records of all cases of priapism encountered within our multicentre institutional network over the last 10 years. Of these, the cases of high-flow priapism treated with embolisation were analysed in depth and compared with the current literature. RESULTS: Overall, 93 patients in our network were diagnosed with priapism from 1 January 2012 to 1 January 2022. And 89 of these patients (96%) had low-flow priapism and four patients (4%) had high-flow priapism. Of these four patients, two were treated within our network with super-selective Gelfoam embolisation of the internal pudendal artery. Following embolisation, both patients achieved rapid detumescence and returned to baseline premorbid erectile function. There was no report of recurrence or erectile dysfunction on follow-up. CONCLUSION: Super-selective embolisation of the internal pudendal artery should be considered as a treatment option for high-flow priapism, with Gelfoam as an appropriate temporary embolic agent of choice. We show that it was a safe and effective option for the patients treated in this series, enabling quick and long-term return to baseline erectile function. Our results support data provided by the limited number of cases in the literature.

A Pilot Investigation Generating an Alternative Therapeutic Strategy Combining Deproteinized Bovine Bone and Gelatin Sponge for a Novel Implant Material in Sinus Floor Elevation Operation.

BACKGROUND Implant placement in the posterior maxilla is typically complicated by a shortage of bone. Gelatin sponge could be combined with an appropriate material to enhance mechanical strength and maintain stability of an implant. This study aimed to evaluate the clinical application of bone grafting with bovine bone mixed with gelatin sponge. MATERIAL AND METHODS Fifty-four patients were divided into a control group (deproteinized bovine bone, n=26) and a test group (deproteinized bovine bone combined with gelatin sponge, n=28). Implants were placed in patients simultaneously after surgery (operation). Cone-beam computed tomography examination was carried out immediately and 6 months after surgery. Space with grafting materials was measured with Mimics software (version 16.0). RESULTS No remarkable differences were found for simultaneous placement, height of residual bone, delayed placement, width of residual bone, graft volume immediately after surgery (V1), graft volume 6 months after surgery (V2), or volumetric change rate between the test group and the control group (P>0.05). Graft volume V2 was remarkably decreased compared with V1 in the control and test groups (P=0.01). There were no significant differences for bone height immediately after surgery (H1) and bone height at 6 months after surgery (H2) between the 2 groups. Bone height H2 was markedly decreased compared with H1 (P<0.05). At 1 year after implantation, there was 1 implant loss in the control group and 2 in the test group. The implant survival rate in the control group was 97.62% and 95.24% in the test group. CONCLUSIONS Absorbable gelatin sponge combined with bovine bone particles was an effective and economical material for use in routine sinus floor elevation surgery.

Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial.

OBJECTIVE: When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA). METHODS: We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups. RESULTS: The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of -13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups. CONCLUSIONS: The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.

Ovarian reserve and recurrence 1 year post-operatively after using haemostatic sealant and bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy.

RESEARCH QUESTION: Is there a difference in the ovarian reserve 1 year post-operatively in those who used a haemostatic sealant or bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy for ovarian endometriomas? DESIGN: This was an extended follow-up observational study of a previous randomized controlled trial where women aged 18 to 40 years with 3-8 cm unilateral or bilateral endometriomas were randomized to receive haemostasis by a haemostatic sealant or bipolar diathermy following ovarian cystectomy. The primary outcome was the ovarian reserve as assessed by antral follicle count (AFC) 1 year post-operatively. Secondary outcomes included the recurrence rate of ovarian endometrioma, the change in anti-Müllerian hormone (AMH) and FSH concentrations, and reproductive outcomes. RESULTS: The significant increase in AFC at 3 months after initial surgery (P = 0.025) in the haemostatic sealant group compared with the diathermy group was sustained at 1 year (P = 0.024) but there was no difference in AMH or FSH concentrations between the groups throughout the follow-up period. The recurrence rate in the FloSeal group was 7.7% (n = 3/39) compared with 22.2% (n = 8/36) in the diathermy group (P = 0.060). The recurrence rate in women who had bilateral lesions was significantly higher than those with unilateral lesions (risk ratio 5.33, interquartile range 1.55-18.38). No difference in reproductive outcomes was found between the two groups. CONCLUSIONS: Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produces a significantly greater improvement in AFC, which was apparent at 3-month follow-up, and was sustained at 1-year follow-up without compromising the recurrence rate.

Gelfoam slurry tract occlusion after computed tomography-guided percutaneous lung biopsy: Does it prevent major pneumothorax?

INTRODUCTION: Computed tomography (CT)-guided lung biopsy is a frequently performed procedure in the diagnostic workup for suspicious lung nodules that can be complicated by pneumothorax. This retrospective study assessed the efficacy of biopsy tract occlusion with a gelatin sponge slurry for preventing post-biopsy pneumothorax. METHODS: Retrospective analysis was conducted on consecutive adult patients who underwent CT-guided lung biopsy over a 10-year period. Age, gender, existing chronic obstructive pulmonary disease (COPD), evidence of emphysema on CT, location of the lesion and the presence of pneumothorax on post-procedure CT and 4-h chest radiograph were recorded. RESULTS: Two hundred and ninety-six patients were included (126 patients in the non-gelfoam group and 170 in the gelfoam group). When gelfoam was used, risk of developing an immediate pneumothorax was lower (P = 0.032). Patients with emphysema were 2.4 times more likely to develop a delayed pneumothorax without gelfoam (P = 0.034). There was a significantly higher risk of both immediate and delayed pneumothorax in non-peripheral lesions without gelfoam (P = 0.001 and P = 0.002, respectively). The frequency of requiring a chest tube to treat a pneumothorax was 86% lower when gelfoam was used (P = 0.012). CONCLUSION: Gelfoam is effective in preventing immediate pneumothorax. In patients with emphysema, there was a significantly higher risk of delayed pneumothorax without gelfoam. Additionally, non-peripheral lesions were more likely to develop pneumothorax when gelfoam was not used. The use of gelfoam was especially important in preventing the development of major pneumothoraces that would require drainage with a chest tube.

Multicenter phase III trial of regenerative treatment for chronic tympanic membrane perforation.

OBJECTIVE: To evaluate the efficacy and safety of regenerative treatment for tympanic membrane perforation (TMP) using gelatin sponge, basic fibroblast growth factor (bFGF), and fibrin glue. METHODS: This was a multicenter, non-randomized, single-arm study conducted at tertiary referral centers. Twenty patients with chronic TMP (age 23-78 years, 6 males, 14 females) were registered from three institutions. All treated patients were included in the safety analysis population. The edges of the TMP were disrupted mechanically by myringotomy and several pieces of gelatin sponge immersed in bFGF were placed and fixed with fibrin glue to cover the perforation. The TMP was examined 4 ± 1 weeks later. The protocol was repeated up to four times until closure was complete. The main outcome measures were closure or a decrease in size of the TMP, hearing improvement, and air-bone gap evaluated 16 weeks after the final regenerative procedure (FRP). Adverse events (AEs) were monitored throughout the study. RESULTS: Total closure of the TMP at 16 weeks was achieved in 15 out of 20 patients (75.0%, 95% confidence interval [CI]: 50.9%-91.3%) and the mean decrease in size was 92.2% (95%CI: 82.9%-100.0%). The ratio of hearing improvement and the air-bone gap at 16 weeks after FRP were 100% (20/20; 95%CI: 83.2%-100%) and 5.3 ± 4.2 dB (p <0.0001), respectively. Thirteen out of 20 patients (65.0%) experienced at least one AE, but no serious AEs occurred. CONCLUSION: The results indicate that the current regenerative treatment for TMP using gelatin sponge, bFGF, and fibrin glue is safe and effective.

Psammomatous melanotic schwannoma - a rare neck lump.

This case report discusses a cervical psammomatous melanotic schwannoma - a rare form of peripheral nerve sheath tumour - which may be highly vascular and is often associated with the Carney complex. Significant intraneural bleeding, which was encountered intraoperatively, was controlled successfully with a gelatine-based thrombin haemostatic agent (Floseal®, Baxter International, Deerfield, IL, USA) without complication.

A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic agents for uterine fibroid embolisation.

AIM: To evaluate the effectiveness of a novel, resorbable, spherical embolic agent compared with other established agents, by studying percentage fibroid infarction (the best indicator of long-term symptom improvement) in patients undergoing uterine fibroid embolisation (UFE). MATERIALS AND METHODS: This retrospective cohort study examined six different embolic agents used for fibroid embolisation, including a new gelatin-based, fully resorbable, spherical agent. The primary effectiveness outcomes were magnetic resonance imaging (MRI)-determined dominant fibroid infarct percentage (DF%) and all fibroid percentage infarct (AF%) at 3 months post-embolisation. MRI-determined uterine artery patency rate was the secondary outcome. Chi-squared test (χ2), relative risk (RR) calculation (primary outcomes), and analysis of variance (ANOVA) (secondary outcome) were the statistical tests employed. RESULTS: One hundred and twenty patients were treated with six embolic agents (20 consecutive patients per group, overall mean age 44.8±6.4, initial uterine volume 570±472 ml, dominant fibroid volume 249±324 ml). Fibroid infarctrates were similar between the cohorts with no significant difference between the new gelatin-based resorbable particle and other embolics in either DF% (χ2=3.92, p=0.56) or AF% (χ2=2.83, p=0.73). Complete DF% RR=1.07 (0.90-1.27) and AF% RR=1.09 (0.85-1.41) suggest non-inferiority of the resorbable particle (d=0.67, p<0.05). A favourable uterine artery patency rate was demonstrated for the resorbable particle compared with gelatin slurry (82.5% versus 27.5%, p<0.001 after Bonferroni adjustment). CONCLUSIONS: This new gelatin-based, fully resorbable particle is an effective embolic agent for fibroid embolisation and achieves an infarct rate non-inferior to established embolics.

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.