Thoracoscopic Management of Chylothorax by Application of a Fibrin Sealant Patch.

Thoracic duct ligation is a demanding procedure when the chyle leak and/or the duct itself are not identified. This report describes 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.

The effect of cyclosporine a in pterygium surgery using fibrin glue.

BACKGROUND/OBJECTIVES: To evaluate the effect of topical cyclosporine A (CsA) 0.05% in patients with pterygium surgery using fibrin glue (FG). SUBJECTS/METHODS: Patients with primary nasal pterygium were retrospectically analyzed and categorized into two groups: Group 1 with 41 eyes from 38 patients as a control group and group 2 with 39 eyes from 36 patients who received topical CsA twice a day for 6 months. Patients were assessed for recurrence rate, tear film parameters, side effects, and complications at postoperative intervals of 1-7 days; 1st, 3rd, 6th and 12th months. The follow-up period was 1 year. RESULTS: The two groups were age (p = 0.934) and sex (p = 0.996) matched. CsA drop was discontinued in one patient due to burning sensation and conjunctival hyperemia after 1 week. There was no statistically significant difference between the mean preoperative and postoperative 1st year Schirmer I and tear break-up time (TBUT) values in group 1 (p = 0.136; p = 0.069). Although the difference between the mean preoperative and postoperative 1st year TBUT values in group 2 was not statistically different (p = 0.249), Schirmer I results were higher postoperatively (p = 0.003). There was no statistically significant difference between preoperative Schirmer (p = 0.496), postoperative Schirmer (p = 0.661), preoperative TBUT (p = 0.240) and postoperative TBUT (p = 0.238) results of the two groups. Recurrence was observed in only one patient from group 1. CONCLUSION: No recurrent pterygium cases were observed in group 2. Schirmer I values were higher postoperatively in group 2; thus,topical CsA treatment may improve lacrimal secretion and be effective after pterygium surgery with FG.

CT-guided Fibrin Glue Occlusion of Cerebrospinal Fluid-Venous Fistulas.

Background Cerebrospinal fluid-venous fistulas (CVFs) are one of the less common etiologic causes of spontaneous intracranial hypotension. CVFs are most commonly treated with open surgical ligation and have reportedly not responded well to percutaneous treatments. Purpose To study treatment outcomes of CT-guided fibrin glue occlusion for CVFs. Materials and Methods Retrospective review of medical records from two institutions was performed for all patients with CVFs who underwent CT-guided percutaneous fibrin glue occlusion from March to October 2020. CVFs were assessed for resolution or persistence at posttreatment decubitus CT myelography (CTM). Pre- and posttreatment brain MRI scans were reviewed for principal signs of spontaneous intracranial hypotension. Clinical symptoms were documented before and immediately after therapy, and the current symptoms to date after fibrin glue occlusion were documented. Results CT-guided fibrin glue occlusion was performed in 13 patients (mean age, 62 years ± 14 [standard deviation]; eight women) with CVFs. Ten of 10 patients who underwent final posttreatment decubitus CTM examinations showed CVF resolution. All 13 patients showed improvement on posttreatment brain MRI scans. All 13 patients are currently asymptomatic, although three patients were asymptomatic before fibrin glue occlusion. Conclusion CT-guided fibrin glue occlusion is an effective treatment for patients with cerebrospinal fluid-venous fistulas (CVFs). Direct fibrin glue administration within the CVF may be one of the key factors for success. Further studies are needed to determine the long-term efficacy of this treatment. © RSNA, 2021.

Evaluation of the hemostatic effect of a combination of hemostatic agents and fibrin glue in a rabbit venous hemorrhage model.

BACKGROUND: In neurosurgery, it is important to use local hemostatic agents. We have explored a more powerful method of hemostasis by the combination of commercially available hemostatic agents with fibrin glue in the hopes of synergistic effects. METHOD: A bleeding model was constructed by puncturing the rabbit posterior vena cava with a needle. After applying the sample to the bleeding point, compression was performed for 10 s. If temporary hemostasis was achieved after pressure release, a 30 s wash was performed to confirm that ultimate hemostasis was achieved. Up to three hemostasis attempts were performed on the same bleeding point until hemostasis was achieved, and the number of attempts required for hemostasis was counted. If hemostasis was not achieved after three attempts, it was counted as four times. Four groups were evaluated: (1) gelatin sponge alone, (2) gelatin sponge + fibrin glue, (3) oxidized cellulose alone, and (4) oxidized cellulose + fibrin glue; each group was tested 16 times. RESULTS: The median value (range minimum value-maximum value) of the number of hemostatic attempts in Group 1 to Group 4 was 3 (1-4), 1 (1-1), 4 (4-4), and 4 (2-4). In Group 2, there were two test exclusions owing to deviations of the test procedure. CONCLUSIONS: The compatibility of gelatin sponge and fibrin glue was very good, with a very strong and rapid hemostatic effect compared to other methods, showed its usefulness. This combination method may be effective for a variety of venous hemorrhages in neurosurgery.

Endovascular and percutaneous transabdominal embolisation of pseudoaneurysms in pancreatitis: an experience from a tertiary-care referral centre.

AIM: To analyse the technical challenges, clinical success, and associated complications of endovascular and percutaneous embolisation of pancreatitis-related pseudoaneurysms. MATERIALS AND METHODS: A retrospective study of patients referred for embolisation of pancreatitis-related pseudoaneurysms between January 2014 and March 2019 was conducted. Computed tomography angiography (CTA) was performed to assess the morphology of the aneurysms prior to any intervention. Percutaneous or endovascular embolisation was performed. Details of CTA and methods of embolisation were recorded. Technical success, clinical success, and complications were reported. RESULTS: A total of 80 patients (mean age, 40.69 ± 13.41 years, 73 male) underwent embolisation during the study period. Pseudoaneurysms were related to chronic pancreatitis (CP) in 44 (55%) patients and acute pancreatitis (AP) in 36 (45%) patients. Pseudoaneurysms were detected in 65 (81.2%) patients on CTA. The most common site of pseudoaneurysms was gastroduodenal artery (GDA) followed by splenic artery. Seven patients were treated with percutaneous thrombin injection and five were treated with percutaneous glue injection under ultrasound/fluoroscopy guidance. The remaining patients (n=68) underwent catheter angiography with endovascular embolisation. Technical success was achieved in 4/7 (57%) percutaneous thrombin cases and in all the cases (5/5, 100%) with percutaneous glue or endovascular (68/68,100%) embolisation. CONCLUSION: Endovascular or percutaneous embolisation of pseudoaneurysms has high technical success with an excellent safety profile.

Fibrin Sealant Patch for the Management of Intractable Bleeding From an LVAD Apex Cannula.

BACKGROUND: Intractable bleeding from the apical cannulation site of a left ventricular assist device (LVAD) is a dreaded complication. CASE REPORT: A 52-year-old male suffering from dilative cardiomyopathy (DCM) with fixed pulmonary hypertension underwent reoperative LVAD implantation after previous mitral valve surgery. The patient underwent three rethoracotomies for bleeding from the apex cannulation site without achieving hemostasis. Conventional techniques and application of fibrin sealants and polymeric sealing devices did not fix the problem. The bleeding stopped after application of the EVARREST® Fibrin Sealant Patch (FSP), and he needed no further transfusions. CONCLUSION: This patch might become a useful tool for intractable bleeding problems in LVAD surgery.

Use of human fibrin glue (Tisseel) versus suture during transvaginal natural orifice ovarian cystectomy of benign and non-endometriotic ovarian tumor: a retrospective comparative study.

BACKGROUND: To evaluate the use of a human fibrin glue (Tisseel) for minor bleeding control and approximation of ovarian defect during transvaginal natural orifice ovarian cystectomy (TNOOC) of benign and non-endometriotic ovarian tumors. METHODS: A total of 125 women with benign and non-endometriotic ovarian tumors who underwent TNOOC between May 2011 and January 2020: 54 with the aid of Tisseel and 71 with traditional suture for hemostasis and approximation of ovarian defect. Surgical outcomes such as length of surgery, operative blood loss, postoperative pain score, and postoperative hospital stay were recorded. Before and immediately (10 days) and at 6 months after the procedure, serum anti-Müllerian hormone (AMH) levels were also determined. RESULTS: Complete hemostasis and approximation of ovarian defect were achieved in all cases. No significant difference was noted in the operating time, operative blood loss, postoperative pain scores after 12, 24 and 48 h, length of postoperative stay, and baseline AMH levels between the two groups. The operation did not have a negative effect on the immediate and 6-month postoperative AMH levels in the suture group. However, the decline in the AMH levels was significant immediately after surgery in the Tisseel group, nevertheless, no significant difference was noted in the AMH levels at 6 months (3.3 vs. 1.7 mg/mL; p = 0.042, adjusted p = 0.210). CONCLUSION: The use of Tisseel in TNOOC of benign and non-endometriotic ovarian tumors without suturing the ovarian tissue is clinically safe and feasible.

Steroid injection and polyglycolic acid shielding to prevent stricture after esophageal endoscopic submucosal dissection: a retrospective comparative analysis (with video).

BACKGROUND AND AIMS: Postoperative stricture after expansive esophageal endoscopic submucosal dissection (ESD) is a severe adverse event. Previous single-arm reports have suggested that polyglycolic acid (PGA) shielding may prevent stricture. This study was performed to assess the efficacy of this method through a comparative analysis. METHODS: This is a retrospective analysis of 500 consecutive cases of esophageal ESD performed between 2002 and 2018 at the University of Tokyo Hospital. After 2013, patients with a diagnosis of superficial esophageal carcinoma covering more than half of the esophageal circumference underwent preventive treatment with either PGA shielding or steroid injection + PGA shielding after ESD. The efficacy of these methods for preventing post-ESD stricture was assessed through multivariable logistic regression analysis. RESULTS: The risk of postoperative stricture was especially high in the cervical esophagus (odds ratio [OR], 4.60; 95% confidence interval [CI], 0.65-61.09) and after total circumferential resection (OR, 3.58×103; lower bound of 95% CI, >185). Steroid injection + PGA shielding was the only method significantly effective in preventing stricture (OR, 0.30; 95% CI, 0.10-0.78; P = .009). In the relatively low-risk subgroup (excluding cervical esophageal cancer and complete circumferential resection), the postoperative stricture rates for steroid injection + PGA shielding versus PGA shielding versus control were 18.9% versus 41.4% versus 51.7%, respectively (P = .015). However, the efficacy of this was limited in extremely high-risk cases. CONCLUSION: The combination of steroid injection and PGA shielding is effective for preventing post-ESD stricture. There is a need for even more effective methods for cervical esophageal cancer and complete circumferential resection.

Fibrin and Thrombin Sealants in Vascular and Cardiac Surgery: A Systematic Review and Meta-analysis.

OBJECTIVE: In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery. DATA SOURCES: Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019. REVIEW METHODS: Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model. RESULTS: Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data. CONCLUSION: The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.

INTRAOCULAR APPLICATION OF FIBRIN GLUE AS AN ADJUNCT TO PARS PLANA VITRECTOMY FOR RHEGMATOGENOUS RETINAL DETACHMENT.

PURPOSE: To evaluate the efficacy of intraocular application of fibrin glue to seal the retinal breaks during standard pars plana vitrectomy for primary rhegmatogenous retinal detachment. METHODS: Twenty-six eyes of 26 rhegmatogenous retinal detachment patients were included in the study. Fibrin glue was used to seal the retinal breaks during standard pars plana vitrectomy in all 26 eyes. Each eye was completely filled with a balanced saline solution at the end of the surgery. The success rate of the reattachment surgery, change in best-corrected visual acuity, intraocular pressure, and occurrence of intraoperative and postoperative complications were recorded and analyzed. RESULTS: All eyes, with a mean age of 45.1 ± 18.3 years, were treated with pars plana vitrectomy surgery. During pars plana vitrectomy surgery, the fibrin glue showed excellent adherence and compliance to the retina. The glue was no longer visible through ultrasound scan 14.85 ± 4.56 days after surgery. The retinal breaks were sealed completely, and retina attached in all 26 eyes with no occurrence of rhegmatogenous retinal detachment during the follow-up period. The best-corrected visual acuity at 6 months after operation was significantly improved from preoperation best-corrected visual acuity. After operation, two eyes (2/26) developed an epiretinal membrane. Although three eyes (3/26) had a transient increased intraocular pressure during the 1st week after surgery, the intraocular pressure lowered to the normal range after the application of timolol. One eye (1/26) required daily topical antiglaucoma drops to lower the intraocular pressure. No adverse effects of fibrin glue were observed. CONCLUSION: The fibrin glue provided a superior adhesive effect for sealing retinal breaks, while showing no additional adverse effects. It is a worthy alternative to gas tamponade for rhegmatogenous retinal detachment vitrectomy surgery.

Is There a Scientific Rationale for the Refixation of Delaminated Chondral Flaps in Femoroacetabular Impingement? A Laboratory Study.

BACKGROUND: Debonding of the acetabular cartilage is a characteristic type of hip damage found in cam-type femoroacetabular impingement (FAI), which remains a treatment challenge. In addition to resection, refixation of these flaps using fibrin sealants has been recently suggested. However, there is only limited evidence available that the proposed refixation method results in sufficient viable cartilage formation to ensure long-term flap grafting and restored tissue function. QUESTIONS/PURPOSES: To determine the flap tissue characteristics that would justify refixation of delaminated chondral flaps with a fibrin sealant, we characterized (1) the extracellular matrix (ECM) of chondral flaps in terms of chondrocyte viability and distribution of ECM components and (2) the chondrogenic potential of resident cells to migrate into fibrin and produce a cartilaginous matrix. METHODS: Ten acetabular chondral flaps and three non-delaminated control cartilage samples were resected during surgery. Chondrocyte viability was quantified using a live-dead assay. To assess the ECM, histological staining of glycosaminoglycans, collagen II, and collagen I allowed the qualitative study of their distribution. The ability of chondrocytes to migrate out of the ECM was tested by encapsulating minced flap cartilage in fibrin gels and semi-quantitatively assessing the projected area of the gel covered with migrating cells. The potential of chondrocytes to produce a cartilaginous matrix was studied with a pellet assay, a standard three-dimensional culture system to test chondrogenesis. Positive controls were pellets of knee chondrocytes of age-matched donors, which we found in a previous study to have a good capacity to produce cartilage matrix. Statistical significance of controlled quantitative assays was determined by the Student's t-test with Welch's correction. RESULTS: The proportion of viable chondrocytes in flaps was lower than in nondelaminated cartilage (50% ± 19% versus 76 ± 6%; p = 0.02). Histology showed a disrupted ECM in flaps compared with nondelaminated controls, with the presence of fibrillation, a loss of glycosaminoglycan at the delaminated edge, collagen II throughout the whole thickness of the flap, and some collagen I-positive area in two samples. The resident chondrocytes migrated out of this disrupted ECM in all tested samples. However in pellet culture, cells isolated from the flaps showed a qualitatively lower chondrogenic potential compared with positive controls, with a clearly inhomogeneous cell and matrix distribution and an overall smaller projected area (0.4 versus 0.7 mm; p = 0.038). CONCLUSION: Despite the presence of viable chondrocytes with migration potential, the cells resided in a structurally altered ECM and had limited capacity to deposit ECM, leading us to question their capacity to produce sufficient ECM within the fibrin sealant for stable long-term attachment of such flaps. CLINICAL RELEVANCE: The characterization of delaminated cartilage in cam FAI patients suggests that the refixation strategy might be adversely influenced by the low level of ECM produced by the residing cells.

Percutaneous CT-guided epidural fibrin sealant injection for refractory pediatric post-dural puncture headache.

Post-dural puncture headache is an uncommon entity in young children and adolescents. Percutaneous epidural blood patching has been classically used to manage refractory post-dural puncture headaches. Injectable fibrin sealant has been shown in a few adult cases to relieve symptoms where blood patching has either failed or was not appropriate. We report a 10-year-old boy who experienced rapid relief of post-dural puncture headache symptoms following percutaneous lumbar epidural fibrin sealant injection under computed tomography guidance. Percutaneous epidural fibrin sealant injection may be an acceptable treatment for post-dural puncture headaches refractory to epidural blood patching, or when an epidural blood patch is otherwise contraindicated. The pediatric interventional radiologist should be aware of this off-label use of fibrin sealant.

Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy.

BACKGROUND: Minimizing pharyngocutaneous fistula after total laryngectomy is a perpetual focus for head and neck surgeons. Multiple intrinsic and extrinsic factors have been implicated in the wound healing process. Activated fibrin glue uniquely promotes healing as a tissue adhesive as well as a biochemical growth factor. METHODS: We present a pilot case series of total laryngectomy with simple pharyngeal closure with a single surgeon. Fibrin tissue adhesive was incorporated in all patients along with standardized pre-operative, operative, and post-operative care. Outcomes measured included pharyngocutaneous fistula rate, perioperative complications, and other wound complications as well as long term swallowing function and voice rehab outcomes. We also present a review of the literature for the theoretical basis of using fibrin glue as well as other similar applications. RESULTS: Fibrin tissue adhesive was successfully used in 18 consecutive patients undergoing total laryngectomy and pharyngoplasty. Despite the presence of a variety of wound healing risk factors including prior radiation and tobacco use, there were no pharyngocutaneous fistulas or other significant wound problems. No locoregional or free tissue overlay flap was done. CONCLUSION: Fibrin tissue glue is a readily available, easily applied, and cost-effective adjunct that may reduce pharyngocutaneous fistula.

Effect of Fibrin Sealant on Seroma Formation Post-Incisional Hernia Repair.

Background: Development of seroma after incisional hernia repair is a common complication. Our study aims to compare the outcomes of sublay incisional hernia repairs with or without spray instillation of fibrin glue. Methods: We enrolled fifty patients undergoing incisional hernia repair. In all patients a suction drain was placed in the subcutaneous space. In one group (FG) 4 ml fibrin glue was instilled in the subcutaneous space. In the control group (C) patients did not receive any prevention measure. Wounds fluids were collected on post-operative day 1 (POD) and once daily until drain removal. All patients were followed up by ultrasound on POD 15, 20, 40, 60. Results: Drain fluid production, even if in significantly greater amount in the C group (p 0.01) as compared with the FG group, decreased after POD 1 in both groups. Drain was removed on POD-5 in 80% of FG patients and in 36% of C patients (p 0.01). No infective or bleeding complications were detected. In group FG average hospital stay was of 5.5 ÃÂ+- 2 days versus 7.1 +- 1.5 days in group C (p 0.01). At ultrasounds examination, seroma development was similar among two groups. Conclusions: Spray instillation of fibrin glue during the surgical repair reduces amount of drained fluid and hospital stay without increasing surgical complications. However, seroma occurrence was not significantly reduced.

A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery.

OBJECTIVE: New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated. METHODS: Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity. RESULTS: The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs ≥10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively). CONCLUSIONS: FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries.

Scleral surgical repair through the use of nanostructured fibrin/agarose-based films in rabbits.

Scleral defects can result as a consequence of trauma, infectious diseases or cancer and surgical repair with allogeneic scleral grafts can be required. However, this method has limitations and novel alternatives are needed. Here, the efficacy of acellular nanostructured fibrin-agarose hydrogel-based substitutes (NFAH) in the repair of scleral defects in rabbits was studied. For this, scleral defects of 5-mm diameter were made on 18 adult-male New Zealand rabbits and repaired with acellular NFAH, NFAH crosslinked with genipin (NFAH-GP) or glutaraldehyde (NFAH-GA), allogeneic scleral grafts as control (C-CTR) or not repaired (negative control N-CTR) (n = 3 each). Macroscopic and histological analyses were performed after 40-days. Macroscopy confirmed the repair of all defects in a comparable manner than the C-CTR. Histology showed no degradation nor integration in C-CTR while NFAH-GP and NFAH-GA biomaterials were encapsulated by connective and inflammatory tissues with partial biodegradation. The NFAH were fully biodegraded and replaced by a loose connective tissue and sclera covering the defects. This in vivo study demonstrated that the NFAH are a promising biocompatible and pro-regenerative alternative to the use of allogeneic cadaveric grafts. However, large defects and long-term studies are needed to demonstrate the potential clinical usefulness of these substitutes.

The application of fibrin sealant for the prevention of lymphocele after lymphadenectomy in patients with gynecological malignancies: A systematic review and meta-analysis of randomized controlled trials.

PURPOSE: The aim of the present study was to evaluate the correlation between the use of fibrin-collagen sealants on lymph node dissection areas and formation of lymphocele after lymphadenectomy in patients with gynecological malignancies. MATERIALS AND METHODS: A systematic search of 5 electronic databases for articles published up to November 2018 was performed. All randomized controlled clinical trials (RCTs) which reported outcomes after application of fibrin collagen agents in patients who underwent lymphadenectomy for gynecological malignancies, were finally included in the present meta-analysis. Statistical meta-analysis was performed using the RevMan 5.3 software. RESULTS: A total of 6 RCTs which recruited 481 patients were included in the present study. Meta-analysis revealed significantly decreased total amount of drained fluid and of mean duration of drainage in fibrin sealant group when compared to control, (187 patients MD -86.40 ml 95% CI -100.2 to -72.60 p < 0.00001 and 113 patients MD -1.00 days 95% CI -1.13 to -0,87 p < 0.00001, respectively). No difference in overall incidence of lymphocele and in the incidence of symptomatic ones among the two groups was observed (592 cases OR 0.61 95% CI 0.36 to 1.05 p = 0.08, and 444 cases OR 0.59 95% CI 0.26 to 1.35 p = 0.22, respectively). CONCLUSIONS: The present meta-analysis supports the safety of the use of fibrin sealants in women undergoing pelvic and/or para-aortic lymphadenectomy due to gynecologic cancer but its benefit remains uncertain. It was found effective in reducing the duration and volume of drainage, but it was not associated with difference in the incidence of lymphocele. Further studies are required to confirm our conclusion and broaden our knowledge about its impact on other parameters.

Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study.

BACKGROUND: Esophageal cancer is surgically treated by means of an esophagectomy. However, esophagectomies are associated with high morbidity rates with dehiscence of the anastomosis occurring in 19% of these procedures in the Netherlands. Application of a fibrin sealant may improve mechanical strength of the anastomosis. The aim of this study was to determine the technical feasibility of the application of an autologous fibrin sealant by aerosolized spraying on esophageal anastomoses. METHODS: This study was designed as a single-center feasibility study. Patients undergoing elective minimal invasive esophageal surgery with the creation of a thoracic or a cervical anastomosis were eligible. Fibrin sealant (Vivostat) was applied to the anastomosis intraoperatively. Feasibility was measured using a nine-item checklist, designed for intraoperative application. RESULTS: In total, fifteen patients, between the ages of 43-79 y, were included in this study. One procedure scored eight out of nine points on the feasibility checklist, so application was considered as unsuccessful. The other fourteen procedures obtained a 100% score and were documented as successful procedures. Together, this led to a success rate of 93%. Grade III anastomotic leakage occurred in one of the fifteen patients (6.7%). CONCLUSIONS: This study showed that application of fibrin sealant on esophageal anastomoses is technically feasible and safe. Future studies may investigate the possible protective effects of fibrin sealant application on the development of anastomotic leakage. NCT03251040.

Expanding Hydrophobically Modified Chitosan Foam for Internal Surgical Hemostasis: Safety Evaluation in a Murine Model.

BACKGROUND: A novel injectable expanding foam based on hydrophobically modified chitosan (HM-CS) was developed to improve hemostasis during surgeries. HM-CS is an amphiphilic derivative of the natural biopolymer chitosan (CS); HM-CS has been shown to improve the natural hemostatic characteristics of CS, but its internal safety has not been systematically evaluated. The goal of this study was to compare the long-term in vivo safety of HM-CS relative to a commonly used fibrin sealant (FS), TISSEEL (Baxter). METHODS: Sixty-four Sprague-Dawley rats (275-325 g obtained from Charles River Laboratories) were randomly assigned to control (n = 16) or experimental (n = 48) groups. Samples of the test materials (HM-CS [n = 16], CS [n = 16], and FS [n = 16]) applied to a nonlethal liver excision (0.4 ± 0.3 g of the medial lobe) in rats were left inside the abdomen to degrade. Animals were observed daily for signs of morbidity and mortality. Surviving animals were sacrificed at 1 and 6 wk; the explanted injury sites were microscopically assessed. RESULTS: All animals (64/64) survived both the 1- and 6-wk time points without signs of morbidity. Histological examination showed a comparable pattern of degradation for the various test materials. FS remnants and significant adhesions to neighboring tissues were observed at 6 wk. Residual CS and HM-CS were observed at the 6 wk with fatty deposits at the site of injury. Minimal adhesions were observed for CS and HM-CS. CONCLUSIONS: The internal safety observed in the HM-CS test group after abdominal implantation indicates that injectable HM-CS expanding foam may be an appropriate internal use hemostatic candidate.

Healing after Resection of Colonic Endometriosis and Growth Factor-enriched Agents: An Experimental Rat Model.

STUDY OBJECTIVE: To examine the potential beneficial effect of platelet-rich plasma (PRP) and fibrin sealant (TISSEEL; Baxter Healthcare Corporation, Deerfield, IL) on bowel wound healing after shaving of an experimentally induced endometriotic lesion. DESIGN: A single-blind, randomized study (Canadian Task Force classification I). SETTING: A certified animal research facility. ANIMALS: Thirty female Sprague-Dawley rats. INTERVENTIONS: Experimental colonic endometriosis was induced by transplanting endometrial tissue to all animals (first surgery). Thirty rats were then randomized to 1 of 3 groups according to treatment; PRP (group 1, n = 10), fibrin sealant (group 2, n = 10), or no agent (group 3, n = 10) was applied after shaving of the endometriotic nodule (second surgery). MEASUREMENTS AND MAIN RESULTS: Colonic endometriosis was successfully induced in all subjects. Four days after the second surgery, the animals were euthanized, and microscopic evaluation was performed. The pathologist was blinded to the treatment method. Histopathologic analysis revealed that compared with the control group, collagen disposition was found in a significantly higher expression in both the PRP and fibrin sealant groups (p = .011 and p = .011, respectively). Distortion of the integrity of the colon layers was statistically more pronounced in the control group compared with the fibrin sealant group (p = .033), whereas greater new blood vessel formation was observed in the fibrin sealant group compared with the control (p = .023). No histologic evidence of residual or recurrent disease was detected. CONCLUSION: Both PRP and fibrin sealant appear to be safe and associated with improved tissue healing during shaving for the excision of colonic endometriosis, attributed to the enhanced collagen disposition, neovascularization, and protection of the integrity of colon layers. Clinical trials are warranted to confirm the feasibility of PRP and fibrin sealant in the clinical setting.