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This Phase I/II randomized, controlled, multicenter study aimed to evaluate the safety and efficacy of sFilm-FS compared to Tachosil® in patients undergoing elective liver surgery requiring hemostasis at the liver surface. sFilm-FS is a new fibrin sealant patch, coating on a biodegradable tri-block polymeric film. The trial included 33 patients randomized 1:1 to receive sFilm-FS or Tachosil®. While most patients underwent liver resection, a subset underwent other hepatic surgical interventions. Safety was the primary outcome, including treatment-emergent adverse events, coagulopathies, and intraoperative blood loss. Efficacy was assessed as secondary endpoints by the time to hemostasis and hemostasis at 2, 3, 5, 7, and 10 ​min from product application. Hemostasis was defined as the absence of bleeding at the target bleeding site within 10 ​min. Both treatments were well tolerated, with no significant differences in adverse events. All patients achieved hemostasis within 10 ​min. The median time to hemostasis was 2 ​min for sFilm-FS and 3 ​min for Tachosil®. sFilm-FS is a promising, well tolerated, fibrin sealant patch, offering the potential for a superior Fibrin Sealant patch that could improve surgical outcomes. Further studies are recommended to validate these findings in larger populations. •SFilm-FS achieved faster median hemostasis (2 ​min) vs. Tachosil (3 ​min) in liver resection.•No anti-fibrinogen antibody response detected in sFilm-FS patients during 6-month follow-up.•SFilm-FS is semi-transparent, enabling clear visibility of the target bleeding site.•SFilm-FS demonstrated suitability for minimal invasive surgery due to its thin, flexible structure.•SFilm-FS contains significantly lower fibrinogen levels, reducing production costs and immunogenicity risk.

BackgroundA novel method for the prevention of bleeding after gastric endoscopic submucosal dissection (ESD) is necessary, as the numbers of patients taking antithrombotic agents have increased. This study aimed to assess the efficacy and safety of the covering method using polyglycolic acid (PGA) sheets and fibrin glue for ESD-induced ulcer in preventing post-ESD bleeding in patients under continued antithrombotic agents.MethodsOne hundred five consecutive gastric tumors among 84 patients who were treated by ESD under continued antithrombotic agents between April 2014 and September 2015 were enrolled in this study. The patients were classified into two groups, the covering group (52 lesions among 38 patients; those with ESD in whom PGA sheets and fibrin glue were used as the covering method) and the control group (53 lesions among 46 patients; ESD only), and their post-ESD bleeding rates were compared.ResultsNo significant differences were seen in the number and type of antithrombotic agents, lesion location, median procedure time, and median resected specimen size between the groups. ESD was completed in all cases, with no cases of uncontrollable bleeding during the procedure. Post-ESD bleeding occurred in 5.8% (3/52) and 20.8% (11/53) in the covering and control groups, respectively. The post-ESD bleeding rate significantly differed between the groups (P = 0.04; odds ratio, 0.23; 95% confidential interval, 0.06–0.89). No adverse events were associated with the use of PGA sheets and fibrin glue.ConclusionsThe covering method using PGA sheets and fibrin glue has the potential to reduce post-ESD bleeding in patients receiving continued antithrombotic agents.

Purpose Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel ® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery. Methods A multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel ® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel ® or additional sutures (‘Sutures’). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints). Results Forty subjects (0.6–17 years) were randomized to Evicel ® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel ® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel ® . Conclusion This small-scale prospective study shows Evicel ® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel ® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).

This study evaluated the efficacy of fibrin glue for preventing postendoscopic submucosal dissection (ESD) bleeding in high-risk patients for bleeding (expected iatrogenic ulcer size ≥40 mm or receiving antithrombotic therapy). A multicenter, open-label, randomized controlled trial was performed at 4 tertiary medical centers in South Korea between July 1, 2020, and June 22, 2022. Patients with gastric neoplasm and a high risk of post-ESD bleeding were enrolled and allocated at 1:1 to a control group (standard ESD) or a fibrin glue group (fibrin glue applied to iatrogenic ulcers after standard ESD). The primary outcome was overall bleeding events within 4 weeks. The secondary outcomes were acute bleeding (within 48 hours post-ESD) and delayed bleeding (48 hours to 4 weeks post-ESD). In total, 254 patients were randomized, and 247 patients were included in the modified intention-to-treat population (125 patients in the fibrin glue group and 122 patients in the control group). Overall bleeding events occurred in 12.0% (15/125) of the fibrin glue group and 13.1% (16/122) of the control group ( P = 0.791). Acute bleeding events were significantly less common in the fibrin glue group than in the control group (1/125 vs 7/122, P = 0.034). Delayed bleeding events occurred in 11.2% (14/125) in the fibrin glue group and 7.3% (9/122) in the control group ( P = 0.301). This trial failed to show a preventive effect of fibrin glue on overall post-ESD bleeding in high-risk patients. However, the secondary outcomes suggest a potential sealing effect of fibrin glue during the acute period.

Background Laparoscopic sleeve gastrectomy (LSG) is associated with serious complications, such as staple line (SL) leaks and bleeding. In order to prevent the occurrence of these complications, surgeons have advocated the need to strengthen the staple line. The aim of this randomized controlled study was to compare the efficacy of three different ways of strengthening of the SL in LSG in preventing surgical post-operative complications. Methods Between April 2012 and December 2014, 600 patients (pts) scheduled for LSG were prospectively randomized into groups without SL reinforcement (group A) or with SL reinforcement including fibrin glue coverage (group B), or oversewn SL with imbricating absorbable (Monocryl™; group C) or barbed (V lock®) running suture (group D). Primary endpoints were post-operative leaks, bleeding, and stenosis, while secondary outcomes consisted of the time to perform the staple line reinforcement (SLR) and total operative time. Results Mean SLR operative time was lower for group B (3.4 ± 1.3 min) compared with that for groups C (26.8 ± 8.5 min) and D (21.1 ± 8.4 min) ( p  < 0.0001). Mean total operative time was 100.7 ± 16.4 min (group A), 104.4 ± 22.1 min (group B), 126.2 ± 18.9 min (group C), and 124.6 ± 22.8 (group D) ( p  < 0.0001). Post-operative leaks, bleeding, and stenosis were recorded in 14 pts (2.3 %), 5 pts (0.8 %), and 7 pts (1.1 %), respectively, without statistical difference between the groups. Conclusion Our study suggests that SLR during LSG, with an imbricating or non-imbricating running suture or with fibrin glue, is an unrewarding surgical act with the sole effect of prolonging the operative time.

Purpose To describe and compare the autologous fibrin glue and traditional sutures for conjunctival graft attachment in patients undergoing primary pterygium excision surgery. Method A randomized clinical trial included patients who underwent pterygium surgery with conjunctival autologous graft (CAG). Using randomization, a single-trained surgeon performed graft fixation with autologous glue or sutures. The glue was prepared immediately before the surgery, using the patient’s blood components. After centrifugation, the plasma was collected and enhanced with calcium gluconate. Postoperative assessments were performed on Days 1, 7, 21, 30 and 180. The study evaluated postoperative edema and pain and complications. The mean surgical time was compared. Recurrence of the pterygium was assessed 6 months postoperatively. Results The study evaluated 61 eyes. Thirty-three eyes underwent pterygium surgery using the glue technique, and 28 underwent the traditional suture technique. Fifty-one patients (83.60%) had successful graft adhered to at the end of follow-up. Ten patients (10/33) lost their graft in the glue group, and only 69.70% maintained graft presence in the fourth week versus 100% of the patients in the suture group ( p  = 0.001). Pain scores were lower in the glue group, and clinical edema was significantly higher. There was no significant difference in graft retraction or the presence of granuloma, necrosis or postoperative infection. Conclusion Autologous fibrin glue is an affordable option for CAG fixation in particular contexts where commercial fibrin glue is unavailable, and it could offer advantages compared to sutures. A higher graft loss rate was observed and might be related to topical anesthesia, and improvements to the technique are needed. ClinicalTrials.gov Identifier : NCT04151017. https://clinicaltrials.gov/ct2/show/NCT04151017?term=20170467&draw=1&rank=1 .

Background Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. Methods In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min ( T 4 ) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T 2 , T 3 , T 5 , T 7 , and T 10 . Results The rate of hemostasis by T 4 was 92.8% in the FS Grifols group ( n  = 163) and 80.5% in the Surgicel® group ( n  = 162) ( p  = 0.01). The mean TTH was significantly shorter ( p  < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T 2 , T 5 , and T 7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). Conclusions FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.

Background Postoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP. Methods This multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C). Discussion The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety. Trial registration This trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).

Recently, the use of hamstring tendons in anterior cruciate ligament repair has been increasing. However, tendon-to-bone healing occurs slowly, which can be a problem to an early return to sport activities. The use of growth factors from platelets seems to improve tissue healing. We enrolled 40 patients in a prospective study that were submitted to an anatomic reconstruction of the anterior cruciate ligament. Patients were sequentially enrolled into four groups: group A without platelet-rich plasma (PRP); group B with PRP in femoral tunnels at the end of surgery; group C with PRP in femoral tunnels at the end of surgery and intra-articular at 2- and 4 weeks after surgery; group D with PRP activated with thrombin in the femoral tunnels. All patients underwent magnetic resonance imaging of the knee 3 months after surgery to evaluate the signal intensity of the fibrous interzone (FIZ) in the femoral tunnels. We did not find any difference among the groups when comparing the signal intensity of the FIZ on magnetic resonance imaging.

The two-sided 95% CI for the difference in success rates using the Normal approximation Z (pooled) statistic was 37.3% and 59.9%. Since the lower limit of the CI is >0, it is concluded that the success rate in the Bioseal group is significantly higher than the suture group. The incidence of CSF leakage post discharge to 30 (±7) days observed in this study was 0.8% in the Bioseal group and 1.6% in the control group, while the study by Green et al[5] reported CSF leak rates of 2.2% in the FS group vs. 2.0% in the control group. [...]the incidence of SSIs in this trial was extremely low in both groups (0.7% for Bioseal vs. 0 for sutures), whereas the observed incidence of SSIs in the previous study with human FS (EVICEL) was 1.1% in the FS group vs. 2.0% in the control group. [...]only the subjects were blinded to the treatment, while investigators were not, which may result in some biases. [...]the results of this study strongly support the use of Bioseal as an adjunctive sealant to sutured dural repair by showing a markedly increased success rate compared with the control (suture alone). [...]Bioseal may be considered a superior treatment option to sutures alone for the prevention of CSF leakage, with a favorable safety profile.