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1.
Artigo em Inglês | MEDLINE | ID: mdl-38628622

RESUMO

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.

2.
J Endovasc Ther ; : 15266028241237465, 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38528653

RESUMO

INTRODUCTION: 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. TECHNIQUE: 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. RESULT: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

3.
J Biomed Mater Res B Appl Biomater ; 112(4): e35401, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38520703

RESUMO

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.


Assuntos
Hemorragia , Adesivos Teciduais , Humanos , Camundongos , Animais , Hemorragia/prevenção & controle , Adesivo Tecidual de Fibrina/efeitos adversos , Cicatrização , Matriz Extracelular/metabolismo , Adesivos Teciduais/metabolismo
4.
Head Neck ; 46(5): 1146-1151, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38465445

RESUMO

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. CONCLUSION: 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.


Assuntos
Adesivo Tecidual de Fibrina , Esvaziamento Cervical , Humanos , Drenagem , Adesivo Tecidual de Fibrina/uso terapêutico , Hospitalização , Esvaziamento Cervical/métodos , Estudos Prospectivos
5.
Indian J Plast Surg ; 57(1): 60-66, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38450007

RESUMO

Background Skin grafting plays a vital role in post-burn and post-traumatic wound management. Split-thickness skin grafts (STSG) are traditionally fixed using staples or sutures, which have tedious application and their removal necessitates painkillers, medical equipment, and human intervention. As an alternative, fibrin sealant is a biological tissue adhesive, composed of thrombin, calcium, and fibrinogen. Fibrin sealant promotes hemostasis and acts as a biological adherent. Objective The aim of this study was to evaluate the outcomes (graft take, wound healing and complications) of fibrin sealant and staples for STSG fixation. Methods It is a randomized controlled trial on 40 patients with wounds of minimum 400 cm 2 . Wound area was divided into equal halves and randomly allocated to the study group or control group. In the study group, 4 mL per 200 cm 2 of fibrin sealant was sprayed followed by STSG application. In the control group, STSG was fixed with only skin staples. Evaluation was done on postoperative days 3, 5, 15, and 30 for graft take, hematoma/seroma, infection, and complete wound healing. Results The mean graft take was significantly higher ( p -value < 0.05) in the study group than in the control group (91 vs. 89%). No seroma or hematoma formation was seen in either group. Complete wound healing was seen in more patients in the study group, but the difference was statistically insignificant. Conclusion Fibrin sealant is an excellent alternative to staples for skin grafting, with the advantage of better graft take and being free of pain that is incurred during staple removal.

6.
Aesthetic Plast Surg ; 2024 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-38456891

RESUMO

The following questions guided the study: Can the use of fibrin glue in drainless rhytidoplasty reduce hematoma prevalence, seroma prevalence increase patient satisfaction or decrease the length of hospital in the adult population compared with standard treatment? The following inclusion and exclusion criteria apply: The procedure performed was rhytidoplasty for both groups. Participants were limited to adults who did not have any other procedure performed during the study. The intervention consisted of the use of fibrin glue without drains compared to the control group, in which drains and/or pressure dressing were applied. Databases: clinicaltrials.gov, MEDLINE, COCHRANE, mRCT, PubMed, Google Scholar, Scopus, Embase, VHL, GHL were searched on 03/25/2023 by 2 different investigators. The Cochrane Risk of Bias Tool 2.0 was used. Five studies were included with a total number of 1277 participants (2554 face sides). The cumulative hematoma rate was OR 0.47 (95% CI 0.26-0.84) in favor of using fibrin glue. Insufficient data were available to assess seroma rate, patient satisfaction, and length of hospital stay. The risk of study bias was judged to be low and moderate. The certainty for the use of fibrin sealant versus drainage is high and the importance of outcomes is rated as important in the GRADEpro GDT tool. Fibrin glue use is more beneficial comparing to drainage in patients undergoing rhytidectomy in terms of hematoma prevalence. This study was registered in PROSPERO (CRD42023421475).Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

7.
Heart Lung Circ ; 2024 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-38413288

RESUMO

Thoracic duct ligation is a demanding procedure when the chyle leak and/or the duct itself are not identified. This report is of a new procedure using thoracoscopic closure of the chyle leak by application of a fibrin sealant patch. This strategy was successfully applied for closing (i) a small fistula due to a postoperative lesion of the lymphatic tributary vessels in one case, and (ii) a large fistula due to idiopathic rupture of the thoracic duct in another case.

8.
J Neurosurg ; : 1-9, 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-38394657

RESUMO

OBJECTIVE: CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events. METHODS: In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio. RESULTS: Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI -∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI -∞ to 1.96) and meningitis (0.36, 95% CI -∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI -∞ to 4.66). CONCLUSIONS: Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost. Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).

9.
Bioengineering (Basel) ; 11(1)2024 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-38247955

RESUMO

Biomaterials are used extensively in graft procedures to correct bone defects, interacting with the body without causing adverse reactions. The aim of this pre-clinical study was to analyze the effects of photobiomodulation therapy (PBM) with the use of a low-level laser in the repair process of bone defects filled with inorganic matrix (IM) associated with heterologous fibrin biopolymer (FB). A circular osteotomy of 4 mm in the left tibia was performed in 30 Wistar male adult rats who were randomly divided into three groups: G1 = IM + PBM, G2 = IM + FB and G3 = IM + FB + PBM. PBM was applied at the time of the experimental surgery and three times a week, on alternate days, until euthanasia, with 830 nm wavelength, in two points of the operated site. Five animals from each group were euthanized 14 and 42 days after surgery. In the histomorphometric analysis, the percentage of neoformed bone tissue in G3 (28.4% ± 2.3%) was higher in relation to G1 (24.1% ± 2.91%) and G2 (22.2% ± 3.11%) at 14 days and at 42 days, the percentage in G3 (35.1% ± 2.55%) was also higher in relation to G1 (30.1% ± 2.9%) and G2 (31.8% ± 3.12%). In the analysis of the birefringence of collagen fibers, G3 showed a predominance of birefringence between greenish-yellow in the neoformed bone tissue after 42 days, differing from the other groups with a greater presence of red-orange fibers. Immunohistochemically, in all experimental groups, it was possible to observe immunostaining for osteocalcin (OCN) near the bone surface of the margins of the surgical defect and tartrate-resistant acid phosphatase (TRAP) bordering the newly formed bone tissue. Therefore, laser photobiomodulation therapy contributed to improving the bone repair process in tibial defects filled with bovine biomaterial associated with fibrin biopolymer derived from snake venom.

10.
Neuroradiology ; 66(1): 1-30, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37828278

RESUMO

Tarlov cysts were thought to be anatomic variants of uncertain etiology and clinical significance when initially described over 80 years ago. They are often detected in routine lumbosacral imaging and generally not reported in a differential diagnosis. There is increasing evidence that at least some Tarlov cysts are symptomatic and can have a significant adverse impact on patients' health and well-being. Women are disproportionately affected with this condition, often presenting with long-standing pain and neurological dysfunctions. Significant gender bias has been a concern in the management of these patients. Unfortunately, there is no consensus on patient selection or management approaches for symptomatic Tarlov cysts. This review article updates information on the prevalence, diagnosis, clinical significance, and treatments of these cysts. Based on these findings and experience with over 1000 patient referrals, a treatment decision algorithm for symptomatic Tarlov cysts was constructed to provide guidance for appropriate management of patients with these complex cysts.


Assuntos
Doenças da Coluna Vertebral , Cistos de Tarlov , Humanos , Masculino , Feminino , Cistos de Tarlov/diagnóstico por imagem , Cistos de Tarlov/terapia , Imageamento por Ressonância Magnética , Sexismo , Doenças da Coluna Vertebral/diagnóstico por imagem , Doenças da Coluna Vertebral/terapia , Sacro
11.
Surg Endosc ; 38(3): 1289-1295, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38102397

RESUMO

BACKGROUND AND STUDY AIM: To assess the efficacy and safety of a fibrin sealant for the prevention of leak resulting from mucosal penetration at the esophagus or cardia during a STER procedure to remove gastrointestinal submucosal tumors (SMTs). PATIENTS AND METHODS: Between April 2014 and October 2022, a total of 290 patients with oesophageal or cardiac SMTs underwent STER at our centre. We retrospectively identified patients with oesophageal or cardia SMTs who underwent STER and experienced mucosal penetration of the cardia or oesophagus during the procedure. A total of 31 mucosal penetrations in 30 procedures were included. Of the 31 mucosal penetrations, 12 occurred in the cardia, and the other 19 occurred in the oesophagus. All 31 sites received the fibrin sealant to close the mucosal penetration. Clinical characteristics, procedure-related parameters, detailed data of the mucosal penetrations, and treatment outcomes using the fibrin sealant were reviewed for all 30 patients to assess the efficacy and safety of the fibrin sealant for closure of mucosal penetration at the cardia or oesophagus. RESULTS: For the 31 mucosal penetrations, the mean size was 0.08 ± 0.06 cm2 (range 0.01-0.25 cm2). Mucosal closure using the fibrin sealant was performed successfully in all 31 mucosal penetrations. Of the 31 mucosal penetrations, clips were used in 13 cases. All 30 patients were discharged after a median of 7 days (range 4-20 day) postoperatively. During a mean 62 months (range 6-107 months) follow-up, all 31 mucosal penetrations successfully healed without the occurrence of infection, ulcer, oesophagitis, chest infection or abdominal infection. CONCLUSION: For the closure of mucosal penetration during STER at the cardia or oesophagus, a fibrin sealant is both safe and efficacious. It is necessary to conduct more research on the viability, effectiveness, and safety of using a fibrin sealant to close wider mucosal penetrations.


Assuntos
Ressecção Endoscópica de Mucosa , Neoplasias Esofágicas , Neoplasias Gastrointestinais , Neoplasias Gástricas , Humanos , Cárdia/cirurgia , Cárdia/patologia , Adesivo Tecidual de Fibrina/uso terapêutico , Ressecção Endoscópica de Mucosa/métodos , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/patologia , Estudos Retrospectivos , Esôfago/patologia , Neoplasias Gastrointestinais/patologia , Resultado do Tratamento , Mucosa Gástrica/cirurgia , Mucosa Gástrica/patologia , Neoplasias Esofágicas/cirurgia , Neoplasias Esofágicas/patologia
12.
J Thorac Dis ; 15(10): 5442-5453, 2023 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-37969310

RESUMO

Background: There are few basic comparative data on the sealing effect of various bioabsorbable sheets in combination with fibrin sealant (FS), which is a more effective tool for the control of alveolar air leakage than the single use of FS alone. The objective of this study was to investigate which bioabsorbable sheet had the best sealing effect against alveolar air leakage when used in combination with FS, in terms of material quality, weaving pattern, and/or thickness. Methods: Standardized 20 mm × 30 mm pleural defects were covered with three pieces of the following sheets using the Rub + Soak B technique in an ex vivo porcine lung model. Seal-breaking burst pressure (SBBP) was compared between groups. Experiment 1: 0.15 mm-thick (Group 1), 0.3 mm-thick (Group 2) and 0.5 mm-thick (Group 3) non-woven polyglycolic acid (PGA) felt were compared. Experiment 2: 0.15 mm-thick non-woven PGA felt (Group 1), 0.15 mm-thick meshed oxidised regenerated cellulose (ORC) (Group 4); 0.11 mm-thick woven PGA (Group 5) and 0.18 mm-thick knitted PGA (Group 6) were compared. Experiment 3: TachoSil® alone (Group 7), TachoSil® combined with FS (Group 8) and 0.15 mm-thick non-woven PGA felt (1 piece) (Group 9) were compared. Results: In Experiment 1, SBBP was significantly higher in Group 1 than in Group 3. The SBBP in Group 2 was significantly higher than that in Group 3. In Experiment 2, SBBP in Group 4 was significantly lower than that in Groups 1, 5, and 6. In Experiment 3, SBBP in Group 7 was significantly lower than that in Groups 8 and 9. Conclusions: Regarding the sheet thickness of PGA felt, the 0.15 mm was the most effective. Regarding the material quality, the ORC was the least suitable. TachoSil® combined with FS was comparable to the most effective 0.15 mm-thick non-woven PGA felt.

13.
Transl Androl Urol ; 12(8): 1238-1249, 2023 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-37680221

RESUMO

Background: A penile tunica defect may arise during surgery in patients with Peyronie's disease. Collagen fleece (TachoSil) has recently gained popularity in penile surgery to cover the tunica albuginea (TA) defect associated with clinical success. However, it is not known what the histological outcomes of these grafts are in the penis. We aimed to study the histopathology of the TachoSil graft in an experimental animal model for the regeneration of TA, inflammation, fibrosis, and the underlying cavernous tissue. Methods: Six adult male Sprague Dawley rats were used. The penis was degloved through a circumferential subcoronal incision. A longitudinal 1 mm × 10 mm defect was created at the base of the lateral aspect of the penis. A TachoSil patch (Takeda, Japan) was applied to the defect. The penile skin covering was then restored. At 2 months, the rat penis was excised and examined with hematoxylin, eosin, and trichrome stains. We conducted a literature review of penile grafts in animals for comparison. Results: Rats weighed 369.2 gm (standard deviation: 31.5). At 2 months, all rats showed normal-looking penis with complete healing, no scaring, tethering, or gross inflammatory features. Histopathology of the patch site showed fibrosis, chronic inflammation, and foreign body giant cell reaction. There was no generation of a new TA, or new vascularity. No inflammatory or pathological reaction affected the underlying corpus cavernous tissue. One rat died on the 6th postoperative day. Postmortem showed massive multiorgan hemorrhage consistent with disseminated intravascular coagulopathy (DIC). Unlike some other reported grafts, there is no TA regeneration. Conclusions: TachoSil patching of penile TA defect forms a distinctive barrier against inflammation, protecting the underlying corpus cavernosum. However, no regeneration of the tunica defect is observed at 2 months. DIC is a potential complication of systemic absorption of TachoSil.

15.
BMC Surg ; 23(1): 257, 2023 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-37641071

RESUMO

BACKGROUND: The management of bleeding is paramount to any surgical procedure. With the increased use of less invasive laparoscopic and robotic methods, achieving hemostasis can be challenging since the surgeons cannot manually apply hemostatic agents directly onto bleeding tissue. In this study, we assessed the use of a pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with poly(2-oxazoline) (NHS-POx) for hemostasis in robotic liver resection in a porcine bleeding model. METHODS: The NHS-POx-loaded patch (GATT-Patch), was first evaluated in a Feasibility Study to treat surgical bleeding in 10 lesions, followed by a Comparative Study in which the NHS-POx patch was compared to a standard-of-care fibrin sealant patch (TachoSil), in 36 lesions (superficial, resection, or deep injuries mimicking metastasectomies). For each lesion type, the NHS-POx and fibrin sealant patches were used in an alternating fashion with 18 lesions treated with NHS-POx and 18 with the fibrin patch. Animal preparation and surgical procedures were consistent across studies. The primary outcome was time to hemostasis (TTH) within 3 min for the Feasibility Study and within 5 min for the Comparative Study. RESULTS: In the Feasibility Study, 8 of the 10 NHS-POx-treated lesions achieved hemostasis at 30 s and 3 min. In the Comparative Study, all 18 NHS-POx patch-treated lesions and 9 of the 18 fibrin sealant patch-treated lesions achieved hemostasis at 5 min. Median TTH with NHS-POx vs fibrin sealant patch was 30 vs 300 s (P < 0.001). CONCLUSIONS: In this animal study, hemostasis during robotic liver surgery was achieved faster and more often with the NHS-POx loaded vs fibrin sealant patch.


Assuntos
Hemostáticos , Procedimentos Cirúrgicos Robóticos , Suínos , Animais , Adesivo Tecidual de Fibrina/uso terapêutico , Medicina Estatal , Fígado , Perda Sanguínea Cirúrgica , Hemostáticos/uso terapêutico
16.
Front Surg ; 10: 1149882, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37409068

RESUMO

Fibrin sealants have recently been thoroughly studied in several surgical specialties; however, results are conflicting. We aimed to examine the safety and efficacy of fibrin sealant patients having thyroidectomies. A thorough, systematic literature search was carried out using the terms thyroidectomy and fibrin sealant using PubMed, Cochrane Library, and Clinicaltrials.gov on December 25, 2022. The primary outcome of interest in this review was the amount of drainage, whereas hospitalization, the length of drain retention, and temporary dysphonia were secondary outcomes. Our meta-analysis (n = 249) showed that application of fibrin sealant is associated with lesser total drainage [SMD -2.76 (-4.83, -0.69); P = 0.009; I2 97%], but not with retention time of drainage [SMD -2.35 (-4.71, 0.01); P = 0.05; I2 98%], hospitalization time [SMD -1.65 (-3.70, 0.41); P = 0.12; I2 97%], and transient dysphonia [RR 1.01 (0.27, 3.82); P = 0.99; I2 0%]. The systematic review found that the use of fibrin sealant in thyroid surgery is positive in total volume drainage but not with the retention time of drainage, hospitalization time, and transient dysphonia. It is notable to remember that this interpretation is complicated by uneven, occasionally subpar technique and trial reporting, according to this systematic review's findings.

17.
Sci Prog ; 106(3): 368504231182834, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37427979

RESUMO

BACKGROUND: This phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia. METHODS: Adult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T4) at the study suture line, which was maintained until the closure of the surgical wound. The secondary efficacy endpoints included the proportion of patients achieving haemostasis at 6 min (T6) and 10 min (T10) after treatment application at the study suture line, which was maintained until closure of the surgical wound, as well as the proportion of patients with intraoperative and postoperative rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical site infections and graft occlusions. RESULTS: A total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T4 haemostasis was achieved in 43 (84.3%) patients in the TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T6 (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 1.37; 2.35]) and T10 (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had intraoperative rebleeding. Postoperative rebleeding was reported only in one patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were reported in patients during the study. CONCLUSIONS: Data demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.


Assuntos
Hemostáticos , Ferida Cirúrgica , Adulto , Humanos , Feminino , Masculino , Adesivo Tecidual de Fibrina/uso terapêutico , Ferida Cirúrgica/tratamento farmacológico , Ferida Cirúrgica/etiologia , Perda Sanguínea Cirúrgica/prevenção & controle , Hemostáticos/uso terapêutico , Procedimentos Cirúrgicos Vasculares/efeitos adversos
18.
Muscle Nerve ; 67(6): 522-536, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36905197

RESUMO

INTRODUCTION/AIMS: Peripheral nerve injuries result in impaired neuromuscular interactions, leading to morphological and functional alterations. Adjuvant suture repair methods have been used to improve nerve regeneration and modulate the immune response. Heterologous fibrin biopolymer (HFB), a scaffold with adhesive properties, plays a critical role in tissue repair. The aim of this study is to evaluate neuroregeneration and immune response focusing on neuromuscular recovery, using suture-associated HFB for sciatic nerve repair. METHODS: Forty adult male Wistar rats were distributed into four groups (n = 10): C (control), only sciatic nerve location; D (denervated), neurotmesis and 6-mm gap removal and fixation stumps in subcutaneous tissue; S (suture), neurotmesis followed by suture; and SB (suture + HFB), neurotmesis followed by suture and HFB. Analysis of M2 macrophages (CD206+ ), as well as the morphology and morphometry of nerves, soleus muscle, and neuromuscular junctions (NMJs), were performed at 7 and 30 days after surgery. RESULTS: The SB group had the highest M2 macrophage area in both periods. After 7 days, SB was the only group similar to the C group regarding the number of axons; furthermore, after 30 days, the SB group was closer to the C group concerning blood vessel and central myonuclear numbers, NMJ angle, and connective tissue volume. After 7 days, increases in nerve area, as well as the number and area of blood vessels, were also observed in SB. DISCUSSION: HFB potentiates the immune response, increases axonal regeneration, induces angiogenesis, prevents severe muscle degeneration, and assists in NMJ recovery. In conclusion, suture-associated HFB has major implications for improved peripheral nerve repair.


Assuntos
Adesivo Tecidual de Fibrina , Fibrina , Ratos , Animais , Masculino , Adesivo Tecidual de Fibrina/farmacologia , Ratos Wistar , Nervo Isquiático/lesões , Biopolímeros , Regeneração Nervosa , Suturas
19.
Cartilage ; : 19476035231163273, 2023 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-36974340

RESUMO

OBJECTIVE: Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model. DESIGN: Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated. RESULTS: There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant. CONCLUSIONS: Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.

20.
Eur Arch Otorhinolaryngol ; 280(5): 2489-2495, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-36629932

RESUMO

PURPOSE: The safety of drainless lateral neck dissection (ND) remains to be proven. Hereby, we describe outcomes of drainless ND using fibrin sealant (FS). METHODS: A retrospective, single academic institute, matched cased control. The study group included patients who underwent drainless ND (drainless group), matched to control patients by age, sex, body mass index, laterality and median number of levels dissected. Additional comparison of patients who underwent at least II-IV lateral ND for a thyroid cancer indication was also conducted. Outcomes were post-operative seroma\infections. RESULTS: A total of 118 patients (42 cases and 76 controls) were included in the study. Groups did not differ in pre-operative characteristics, percentage of bilateral ND, and extension of ND. No significant difference was found in terms of post-operative infections, seroma, aspirations, and post-operative antibiotic use. The additional analysis included 23 drainless lateral ND and matched controls, of which 91% underwent concomitant level V dissection. No significant difference was found in terms of post-operative seroma or infection. These findings were confirmed with a multivariate analysis. CONCLUSIONS: Drainless ND using FS in non-violating mucosa surgeries appears to be feasible and safe, without significantly increasing post-operative seroma and its associated complications.


Assuntos
Esvaziamento Cervical , Seroma , Humanos , Estudos de Casos e Controles , Esvaziamento Cervical/efeitos adversos , Estudos Retrospectivos , Seroma/etiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Adesivo Tecidual de Fibrina
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