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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 We assessed quality of life (QoL) of patients undergoing surgery for proximal femur fracture and performed a cost-effectiveness analysis of haemostatic drugs for reducing postoperative bleeding. Methods We analysed data from an open, multicentre, parallel, randomized controlled clinical trial (RCT) that assessed the efficacy and safety of tranexamic acid (TXA group) and fibrin glue (FG group) administered topically prior to surgical closure, compared with usual haemostasis methods (control group). For this study we conducted a cost-effectiveness analysis of these interventions from the Spanish Health System perspective, using a time horizon of 12 months. The cost was reported in $US purchasing power parity (USPPP). We calculated the incremental cost-effectiveness ratio (ICER) per QALY (quality-adjusted life-year). Results We included 134 consecutive patients from February 2013 to March 2015: 42 patients in the TXA group, 46 in the FG group, and 46 in the control group. Before the fracture, EuroQol visual analogue scale (EQ-VAS) health questionnaire score was 68.6. During the 12 months post-surgery, the intragroup EQ-VAS improved, but without reaching pre-fracture values. There were no differences between groups for EQ-VAS and EuroQol 5 dimensions 5 levels (EQ-5D-5L) health questionnaire score, nor in hospital stay costs or medical complication costs. Nevertheless, the cost of one FG treatment was significantly higher (399.1 $USPPP) than the cost of TXA (12.9 $USPPP) or usual haemostasis (0 $USPPP). When comparing the cost-effectiveness of the interventions, FG was ruled out by simple dominance since it was more costly (13,314.7 $USPPP) than TXA (13,295.2 $USPPP) and less effective (utilities of 0.0532 vs. 0.0734, respectively). TXA compared to usual haemostasis had an ICER of 15,289.6 $USPPP per QALY). Conclusions There were no significant differences between the intervention groups in terms of postoperative changes in QoL. However, topical TXA was more cost-effective than FG or usual haemostasis. Trial registration ClinicalTrials.gov: NCT02150720. Date of registration 30/05/2014. Retrospectively registered.

Background CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, but problems have been reported regarding safety, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) as an alternative to commercially available fibrin sealants. Methods/design This single-blinded, prospective randomized controlled interventional trial aims to demonstrate the non-inferiority of L-PRF compared to commercially available fibrin sealants for dural closure. This trial will include patients undergoing cranial neurosurgery (supratentorial and infratentorial) with intentional opening of the dura. Patients are randomized in a 1:1 fashion comparing L-PRF to commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage within 12 weeks after surgery. Secondary endpoints are complications such as bleeding or wound infections. Additionally, a cost-effectiveness analysis is performed. Discussion With this trial, we will evaluate the safety and efficiency of L-PRF compared to commercially available fibrin sealants. Trial registration ClinicalTrials.gov NCT03812120. Registered on 22 January 2019.

Background Recent advances in endoscopic endonasal transsphenoidal approaches (EETA) for skull base lesions have resulted in a significant increase in extent and complexity of skull base defects, demanding more elaborate and novel reconstruction techniques to prevent cerebrospinal fluid (CSF) leakage and to improve healing. Currently, commercially available fibrin sealants are often used to reinforce the skull base reconstruction. However, problems have been reported regarding hypersensitivity reactions, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) membranes as an alternative for commercially available fibrin glues in EETA-related skull base reconstruction reinforcement. Methods/design This multicenter, prospective randomized controlled trial aims to demonstrate non-inferiority of L-PRF membranes compared to commercially available fibrin sealants in EETA cases (1) without intra-operative CSF-leak as dural or sellar floor closure reinforcement and (2) in EETA cases with intra-operative CSF-leak (or very large defects) in which a classic multilayer reconstruction has been made, as an additional sealing. The trial includes patients undergoing EETA in three different centers in Belgium. Patients are randomized in a 1:1 fashion comparing L-PRF with commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage. Secondary endpoints are identification of risk factors for reconstruction failure, assessment of rhinological symptoms, and interference with postoperative imaging. Additionally, a cost-effectiveness analysis is performed. Discussion With this trial, we will evaluate the safety and efficacy of L-PRF compared to commercially available fibrin sealants. Trial registration ClinicalTrials.gov NCT03910374. Registered on 10 April 2019.

Aims:To compare the degree of conjunctival autograft inflammation, subconjunctival haemorrhage (SCH) and graft stability following the use of sutures or fibrin glue (FG) during pterygium surgery.Methods:Prospective, observer masked, clinical trial. 40 eyes of 40 patients undergoing primary pterygium surgery with conjunctival autograft were allocated into two groups. Group 1 (n = 20) had FG (Tisseel) for attaching the conjunctival autograft, whereas group 2 (n = 20) had sutures. Standardised digital slit-lamp photographs were taken at 1 week, 1 month and 3 months postoperatively. Sutures were masked using commercially available photo-editing software. Two masked observers objectively graded the digital photographs for degree of inflammation, SCH and graft stability.Results:34 of the 40 patients completed the study. When using FG, the degree of inflammation was significantly less than with sutures at 1 month (p = 0.019) and 3 months (p = 0.001) postoperatively. No significant difference was found for inflammation at 1 week postoperatively (p = 0.518). Conjunctival grafts secured with FG were as stable as those secured with sutures (p = 0.258, p = 0.076 and p = 0.624, at 1 week, 1 month and 3 months, respectively). No significant difference was found in degree of postoperative SCH between the groups (p = 0.417, p = 1 and p = 1, at 1 week, 1 month and 3 months, respectively).Conclusion:This is the first prospective clinical trial confirming that conjunctival grafts secured with FG during pterygium surgery not only are as stable as those secured with sutures, but also produce significantly less inflammation.

Purpose To investigate pain and other complications following inguinal hernioplasty performed by the Lichtenstein technique with mesh fixation by fibrin glue or sutures. Methods Five hundred and twenty patients were enrolled in this 12-month observational multicenter study and received either sutures or fibrin glue (Tissucol ® /Tisseel ® ) based on the preference of the surgeon. Pain, numbness, discomfort, recurrence, and other complications were assessed postoperatively and at 1, 3, 6, and 12 months. Pain intensity was assessed by a visual analog scale (VAS; 0 [no pain] to 10 [worst pain]). Results One hundred and seventy-one patients received sutures and 349 received fibrin glue. During the early postoperative phase, 87.4% of patients in the fibrin glue group and 76.6% of patients in the sutures group were complication-free ( P  = 0.001). Patients who received fibrin glue were also less likely to experience hematoma/ecchymosis than those in the suture group (both P  = 0.001). The mean pain score was significantly lower in the fibrin group than the sutures group (2.5 vs. 3.2, P  < 0.001). At 1 month, significantly fewer patients in the fibrin glue group reported pain, numbness, and discomfort compared with patients in the sutures group (all P  < 0.05). Fibrin glue patients also experienced less intense pain (0.6 vs. 1.2; P  = 0.001). By 3 months, the between-group differences had disappeared, except for numbness, which was more prevalent in the sutures group. By 12 months, very few patients reported complications. Conclusions Tissucol fibrin glue for mesh fixation in the Lichtenstein repair of inguinal hernia shows advantages over sutures, including lower incidence of complications such as pain, numbness, and discomfort, and should be considered as a first-line option for mesh fixation in hernioplasty.

Background The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. Methods/Design The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. Discussion To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. Trial registration NCT01828892 . Registration date: April 2013.

Background In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). Methods This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. Results At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment ( P  < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P  = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P  < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. Conclusion The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.

Background After total knee replacement, overall blood loss is often underestimated, although it exceeds the visible blood loss caused by bleeding into the tissues or into the joint. The use of fibrin sealants during surgery has been suggested to reduce perioperative blood loss and transfusion rates and may be beneficial for patient recovery and the postoperative function of the joint. Methods/Design This will be a single-centre, single-blinded, randomised controlled trial with a parallel design, for which 68 patients undergoing total knee replacement will be recruited and followed up at 3, 6 and 12 months; 34 will be control patients who will receive the standard orthopaedic surgery treatment (electrocoagulation), and the other 34 will receive the same treatment plus 5 ml EVICEL™ applied during surgery and used according to the manufacturer’s instructions. The primary objective is to test the null hypothesis that the effect of EVICEL™ for controlling haemostasis and reducing postoperative blood loss in patients undergoing total knee replacement is not superior to the use of electrocoagulation alone. The secondary objective is to show that EVICEL™ reduces the need for transfusion, increases range of motion, improves clinical outcome and wound healing, and reduces the need for analgesics. The tertiary objective is to show that EVICEL™ reduces the costs of total knee replacement treatment. Discussion So far, studies on the effect of fibrin sealants in total knee replacement have delivered inconsistent and ambivalent results, indicating that there is still a need for high-evidence studies as proposed in the presented study protocol. Trial registration German registration number DRKS00007564 ; date of registration: 26 November 2014.

Purpose: The study aimed to compare surgical outcomes with likely toxic side effects when using pterygium excision and amniotic membrane grafting with fibrin glue versus Vicryl sutures. Method: This is a prospective randomized study. Patients were classified into two groups: group 1 consisted of 20 patients with Vicryl-sutured grafts, and group 2 consisted of 20 patients with fibrin-glued grafts that were prepared from autologous blood. Results including surgery time, patient discomfort, complications and recurrence rates within 1, 6 and 12 months were analyzed. Results: The study demonstrated that there was a statistically significant decrease in surgery time in the fibrin glue group (the procedure took 17 min) relative to the sutured group (28 min; p < 0.05). Additionally, both postoperative pain and discomfort were noted significantly less often in the fibrin glue group. Complications were also decreased in the fibrin glue group. Conclusion: The study revealed that the use of fibrin glue in pterygium surgery with amniotic membrane grafting was safer, less toxic and less time-consuming, and resulted in fewer complications than graft surgery with sutures.