BACKGROUND: In this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.
METHODS: This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T4 - primary endpoint), seven (T7) and 10 (T10) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.
RESULTS: At T4, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T4 were undergoing soft tissue surgery. All patients achieved hemostasis by T7. At T10, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.
CONCLUSIONS: FS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.
METHODS: I.

UNASSIGNED: Abdominoplasty is a common surgical procedure in which excess abdominal skin and fat are reduced to improve body contouring. Fibrin sealant has been proposed to reduce postsurgical bleeding and exudation. In this study, we evaluated whether there was a significant statistical difference in surgical output between the use of fibrin glue and its nonuse in abdominoplasty surgery, specifically in reducing bleeding and exudation.
UNASSIGNED: A retrospective chart review of 68 postbariatric abdominoplasty patients (58 females, 10 males) was performed. We divided the patients into Group A (30 cases, 44%), in which we used fibrin sealant, and Group B (38 cases, 56%), in which we did not use fibrin glue. We calculated the total amount of liquid in suction drainages until the day of their removal. Statistical analysis included the independent t-test with a significance level of 0.05.
UNASSIGNED: The average drainage output in Group A was 620.0 ± 375.0 mL, whereas in Group B, it was 500.0 ± 290.0 mL. Results indicate an insignificant correlation between the use of fibrin glue and the amount of liquid in the surgical drains (t = 1.52, p = 0.13). The result is not significant at p <.05 according to the independent t-test.
UNASSIGNED: The use of fibrin sealant surely has a high value in all surgical branches to reduce postoperative complications, but in our study, we did not find any advantages in its use for reducing surgical drain output in abdominoplasty patients.

OBJECTIVE:  Using liquid fibrin sealants has once again questioned the benefit of drain placement in head and neck operations. Cellulose-based hemostats offering different hemostasis mechanisms have scarcely been investigated in drainless neck surgeries. This study aimed to evaluate whether liquid fibrin sealant offers any advantage over cellulose-based hemostats in various head and neck surgeries.
METHODS: A prospective trial of patients who underwent various neck surgeries between 2020 and 2022. Baseline characteristics and postoperative outcomes were compared between the drain-placed and the drainless groups, with the latter sub-categorized into three groups: fibrin sealant, cellulose-based hemostats, and a combination of both.
RESULTS: A total of 119 patients were included (63 thyroidectomies, 40 parathyroidectomies, and 16 sialoadenectomies). Fifty eight had a drain placed and 61 had no drain. In the drainless group, 23 patients received cellulose-based absorbable hemostats (SURGICEL®/ FIBRILLAR™); 18 patients had fibrin sealants (EVICEL®/TachoSil®/TISSEEL); in 16, a combination of both was used; and in four patients, no hemostatic agent was used. Three (5%) of the 61 drainless patients developed a seroma compared to one (2%) seroma in the drain-placed patients. No advantage was demonstrated using a combination of FIBRILLAR™ with a fibrin sealant nor for any used separately. Drain placement delayed patient discharge by at least one day compared to the group without a drain (p < 0.001).
CONCLUSIONS: Drain placement offered a minor advantage in the postoperative course reducing rates of seroma formation, while delaying patient discharge by at least one day. There was no advantage in using a specific hemostatic agent over the other.

BACKGROUND: Traditional fixation of autografts in the treatment of burns involves the use of sutures and staples. A novel fibrin sealant, Artiss, has been introduced as an alternate method of fixation and has shown promising safety and efficacy results in the adult population. Our study assessed the effectiveness of fibrin sealant to secure autologous split thickness skin grafts (ASTSG) in the pediatric burn population.
METHODS: We performed a retrospective cohort study of pediatric patients under 18 years of age who received autografting for the treatment of burns at our institution between 2017 and 2023. We compared ASTSG secured with fibrin sealant to those managed traditionally with sutures or staples. Outcomes of interest include the need for return trips to the operating room (OR), time to wound healing, graft take, and total time in the operating room.
RESULTS: 83 patients underwent a total of 142 individual ASTSGs for management of unique body area injuries. 66.3 % were male, median age was 79 months, and scald was the most common mechanism of injury (41.0 %). Forty-five (39.5 %) traditionally affixed ASTSG required at least one return to the OR while only one (3.6 %) ASTSG secured with fibrin sealant required an additional return to the OR (p < 0.001). Graft take was similar in both groups (92.9 % for fibrin sealant vs. 93.9 % for traditional methods, p = 1). Time to wound healing was also similar: 16 vs. 15 days for fibrin glue and traditional methods, respectively (p = 0.23).
CONCLUSIONS: Outcomes from autograft fixation with fibrin sealant were comparable to those treated with traditional methods, with a reduction in the need for return trips to the operating room. These data suggest that fibrin sealant is a suitable alternative to traditional fixation methods in pediatric autografting.

UNASSIGNED: In this experimental protocol, we evaluated the immediate and delayed repair of the buccal branch of the facial nerve (BBFN) with heterologous fibrin biopolymer (HFB) as a coaptation medium and the use of photobiomodulation (PBM), performing functional and histomorphometric analysis of the BBFN and perioral muscles.
UNASSIGNED: Twenty-eight rats were divided into eight groups using the BBFN bilaterally (the left nerve was used for PBM), namely: G1 - control group, right BBFN (without injury); G2 - control group, left BBFN (without injury + PBM); G3 - Denervated right BBFN (neurotmesis); G4 - Denervated left BBFN (neurotmesis + PBM); G5 - Immediate repair of right BBFN (neurotmesis + HFB); G6 - Immediate repair of left BBFN (neurotmesis + HFB + PBM); G7 - Delayed repair of right BBFN (neurotmesis + HFB); G8 - Delayed repair of left BBFN (neurotmesis + HFB + PBM). Delayed repair occurred after two weeks of denervation. All animals were sacrificed after six weeks postoperatively.
UNASSIGNED: In the parameters of the BBFN, we observed inferior results in the groups with delayed repair, in relation to the groups with immediate repair, with a significant difference (p < 0.05) in the diameter of the nerve fiber, the axon, and the thickness of the myelin sheath of the group with immediate repair with PBM compared to the other experimental groups. In measuring the muscle fiber area, groups G7 (826.4 ± 69.90) and G8 (836.7 ± 96.44) were similar to G5 (882.8 ± 70.51). In the functional analysis, the G7 (4.10 ± 0.07) and G8 (4.12 ± 0.08) groups presented normal parameters.
UNASSIGNED: We demonstrated that delayed repair of BBFN is possible with HFB, but with worse results compared to immediate repair, and that PBM has a positive influence on nerve regeneration results in immediate repair.

OBJECTIVE: 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®.
CONCLUSIONS: 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).

Nerve injuries present a substantial challenge within the medical domain due to their prevalent occurrence and significant impact. In nerve injuries, a range of physiopathological and metabolic responses come into play to stabilize and repair the resulting damage. A critical concern arises from the disruption of connections at neuromuscular junctions, leading to profound degeneration and substantial loss of muscle function, thereby hampering motor tasks. While end-to-end neurorrhaphy serves as the established technique for treating peripheral nerve injuries, achieving comprehensive morphofunctional recovery remains a formidable challenge. In pursuit of enhancing the repair process, alternative and supportive methods are being explored. A promising candidate is the utilization of heterologous fibrin biopolymer, a sealant devoid of human blood components. Notably, this biopolymer has showcased its prowess in establishing a stable and protective microenvironment at the site of use in multiple scenarios of regenerative medicine. Hence, this scoping review is directed towards assessing the effects of associating heterologous fibrin biopolymer with neurorrhaphy to treat nerve injuries, drawing upon findings from prior studies disseminated through PubMed/MEDLINE, Scopus, and Web of Science databases. Further discourse delves into the intricacies of the biology of neuromuscular junctions, nerve injury pathophysiology, and the broader utilization of fibrin sealants in conjunction with sutures for nerve reconstruction procedures. The association of the heterologous fibrin biopolymer with neurorrhaphy emerges as a potential avenue for surmounting the limitations associated with traditional sealants while also mitigating degeneration in nerves, muscles, and NMJs post-injury, thereby fostering a more conducive environment for subsequent regeneration. Indeed, queries arise regarding the long-term regenerative potential of this approach and its applicability in reconstructive surgeries for human nerve injuries.

UNASSIGNED: Endovascular aneurysm repair using iodinated contrast agents risks contrast-induced nephropathy, especially in high-risk patients. This technical note describes a contrast-free endovascular aneurysm repair (EVAR) protocol using preoperative imaging measurement and fibrin sealant (FS) filling.
UNASSIGNED: Preoperative imaging measurement and intraoperative guidewire manipulation facilitated anatomical identification without contrast. After endograft deployment, the aneurysm sac was filled with FS if endoleak was indicated by pressure fluctuations.
UNASSIGNED: Between 2017 and 2020, 6 high-risk patients underwent contrast-free EVAR with FS filling. Complete exclusion was achieved in all cases. Over follow-up, no endoleaks, deterioration in renal function, or other complications were observed.
UNASSIGNED: Contrast-free EVAR with FS filling shows early feasibility as an alternative technique for contrast-induced nephropathy (CIN) high-risk patients, while larger studies with long-term monitoring are imperative to validate outcomes.
CONCLUSIONS: This study showcases a contrast-free EVAR technique with fibrin sealant filling for high-risk CIN patients. It offers a safer approach for those with renal challenges, reducing CIN risk. The technique\'s feasibility in a small cohort suggests its utility in treating AAA without iodinated contrast, crucial for patients with specific health risks. For clinicians, it introduces a method that decreases nephrotoxic risks, potentially changing practice for vulnerable patients.

Hemorrhage is the second leading cause of death in patients under 46 years of age in the United States. Cessation of hemorrhage prevents hemorrhagic shock and tissue hypoxia. Controlling the bleed via direct pressure or tourniquet is often the first line of defense, but long-term care requires staples, hemostatic agents, or sealants that seal the vessel and restore blood flow. Here, we compare a new photocurable extracellular matrix sealant (pcECM) with low, medium, and high crosslink density formulations to a commercially available fibrin-based sealant, TISSEEL®. pcECM has potential uses in surgical and remote settings due to room temperature storage conditions and fast preparation time. Here, we determine if pcECM sealant can stop venous hemorrhage in a murine model, adhere to the wound site in vivo throughout the wound-healing process, and has the mechanical properties necessary for stopping hemorrhage. Adjusting pcECM crosslinking density significantly affected viscosity, swelling, burst strength, tensile strength, and elasticity of the sealant. 3-Dimensional ultrasound volume segmentations showed pcECM degrades to 17 ± 8% of its initial implant volume by day 28. Initially, local hemodynamic changes were observed, but returned close to baseline levels by day 28. Acute inflammation was observed near the puncture site in pcECM implanted mice, and we observed inflammatory markers at the 14-day explant for both sealants. pcECM and fibrin sealant successfully sealed the vessel in all cases, and consistently degraded over 14-28 days. pcECM is a durable sealant with tunable mechanical properties and possible uses in hemorrhage control and other surgical procedures.

OBJECTIVE: Lateral neck dissection (LND) is performed for staging/treatment of head and neck lesions. This traditionally includes placement of a drain and inpatient admission. Drainless, day-case head and neck surgery is attractive due to cost-effectiveness and reduced length of stay, but evidence is lacking in LND. We aim to investigate Artiss™ as an alternative to drain placement, facilitating day-case LND.
METHODS: A prospective review was conducted of patients who underwent LND in a UK hospital over a 22-month period.
RESULTS: Thirty-nine patients were identified (27 Artiss™ only; 12 Artiss™ with a drain). Eight Artiss™ only patients were day-case. All drains were removed by post-operative day 2. There was no statistically significant difference in the number of complications between the two groups.
CONCLUSIONS: This observational study demonstrates that for selected patients, Artiss™ could facilitate drainless, day-case LND. Further controlled studies with matched groups and larger numbers are required to validate this.