Fibrin sealant for closure of mucosal penetration at the oesophagus or cardia during submucosal tunnelling endoscopic resection for gastrointestinal submucosal tumours.

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.

The role of sealants for achieving anastomotic hemostasis in vascular surgery.

BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.

Posterior fixation of gastric tube with fibrin sealant in laparoscopic sleeve gastrectomy: a promising method to prevent revision surgeries.

BACKGROUND: We aim to assess the effects of gastric posterior fixation with fibrin sealant in laparoscopic sleeve gastrectomy in aspects of 12th-month body mass index and gastric volume. METHODS: The patients who underwent laparoscopic sleeve gastrectomy between January 2019 and February 2021 were divided into two groups preoperatively. The first 75 patients were appointed to the posterior fixation group, and the second 75 were to the control group. Changes in gastric volume and body mass index were assessed in the postoperative 12th month. RESULTS: There were 110 patients in the final analysis. Fifty-four patients had posterior fixation, and 56 had only laparoscopic sleeve gastrectomy. The posterior fixation group was superior in terms of total weight loss rate (39.1% vs. 34.5%, p<0.001) and less gastric volume increase rate (39.8% vs. 164.7%, p<0.001) in the postoperative 12th month. CONCLUSION: Our study suggests that posterior fixation with fibrin sealant in laparoscopic sleeve gastrectomy is a promising method for preventing weight regain and creating a need for revision surgery.

Bronchoscopic lung volume reduction by instillation of fibrinogen and thrombin in COPD patients with homogenous emphysema.

BACKGROUND: The new endobronchial therapy called biological lung volume reduction (BioLVR) involves using a rapid polymerizing sealant to block off the most emphysematous portions of the lungs. The primary mechanism of action is resorption atelectasis, which is then followed by inflammation and remodeling of the airspace. The remodeling process will result in the formation of scars, leading to the contraction of the lung tissue. As a result, a decrease in functional lung volume is anticipated for a period of 6-8 weeks. OBJECTIVE: Assessing the safety and effectiveness of bronchoscopic installation of (fibrinogen and thrombin) in COPD patients with homogeneous emphysema in terms of radiological, physiological, and quality of life outcomes. METHODS: Between December 2017 and December 2019, 40 COPD patients with homogeneous emphysema were studied using a fiber optic bronchoscope while they were awake but sedated. Tanta University Hospitals' chest medicine department collaborated with the diagnostic radiology department of the Faculty of Medicine. RESULTS: All the following parameters were reduced from their initial values: HRCT volumetry, RV/TLC, mMRC dyspnea scale, CAT score, 6MWT, FEV1, and the FEV1/FVC ratio at the first, third, and sixth months from the beginning (p = 0.001). One individual (0.025%) had pneumonia, whereas three individuals had COPD (0.075%). Using fibrin glue produced locally, biological lung volume reduction (Bio LVR) may be an effective treatment for advanced homogenous emphysema. CONCLUSION: By using locally prepared fibrin glue the biologic lung volume reduction (Bio LVR) may be a convenient method to treat advanced homogenous emphysema.

Efficacy and safety of fibrin sealant application in patients undergoing thyroidectomy: a systematic review and meta-analysis.

Various studies have focused on the application of fibrin sealants (FS) in thyroid surgery. Utilizing a meta-analysis, this systematic review analyzed the findings of recent randomized controlled trials on the safety and efficacy of FS in patients who underwent thyroidectomy. The Cochrane Library, Web of Science, Embase, PubMed, and Medline databases were searched for relevant studies, without any language restrictions. Seven randomized controlled trials were included in the originally identified 69 studies. Overall, 652 patients received FS during thyroid surgery; their outcomes were compared with those of conventionally treated patients. The primary outcomes were total volume of wound drainage, length of hospitalization, and operative time. Significant differences were observed in the total volume of wound drainage (mean deviation (MD): -29.75, 95% confidence interval (CI): -55.39 to -4.11, P = 0.02), length of hospitalization (MD: -0.84, 95% CI: -1.02 to -0.66, P < 0.00001), and surgery duration (MD: -7.60, 95% CI: -14.75 to -0.45, P = 0.04). Secondary outcomes were seroma and hypoparathyroidism development. The risk of hypoparathyroidism did not differ between the FS and conventional groups (I = 0%, relative risk = 1.31, P = 0.38). Analysis of "seroma formation that required invasive treatment" indicated that FS showed some benefit (I2 = 8%, relative risk 0.44, P = 0.15). Heterogeneity among the different trials limited their conclusions. The meta-analysis showed that although FS use did not significantly reduce seroma or hypoparathyroidism incidence in patients after thyroidectomy, it significantly reduced the total drainage volume, length of hospitalization, and duration of surgery.

Pit excision with fibrin glue closure versus lateralizing flap procedures in the management of pilonidal sinus disease in adolescents: a 14-year cohort study.

INTRODUCTION: Pilonidal sinus disease (PSD) arises in the hair follicles of the gluteal cleft with many cases occurring during adolescence. Early studies of pit excision with fibrin glue closure (PEF), a minimally invasive procedure for the management of chronic PSD, suggest it is safe and effective with similar results to traditional lateralizing flap procedures (LFP), without the need for extensive tissue excision and associated complications. However, these studies lack large sample sizes and prolonged follow-up. METHODOLOGY: All children undergoing primary operative procedures for chronic PSD from May 2009 to February 2022 received either a PEF or a LFP. Recurrence and complications rates alongside their demographic and disease severity data were compared using statistical and Kaplan-Meier analyses. RESULTS: Seventy-eight children had 33 primary PEF and 45 primary LFP procedures with a median follow-up of 2.21 and 2.52 years, respectively. Demographic and disease severity indicators were similar between groups (p > 0.05). The overall recurrence rate in each cohort was 3% for PEF and 11% for LFP, respectively (p = 0.2346). The all-cause repeat intervention rate was 12% and 49% in the PEF and LFP cohorts, respectively (p = 0.0007). Kaplan-Meier analysis showed a reduction in the requirement of re-operation in the PEF cohort (p = 0.0340). Operative time was significantly decreased in the PEF cohort compared to the LFP cohort (p < 0.0001). Wound dehiscence was significantly decreased in the PEF cohort compared to the LFP cohort (3% vs 31%; p = 0.0026). CONCLUSION: This 14-year study is the largest pediatric-focused cohort utilizing PEF to manage PSD and demonstrated clinically relevant decreases in symptom recurrence alongside significantly decreased rates of complications and further surgical intervention compared to traditional LFP techniques. We conclude that PEF is a viable minimally invasive technique in the management of pediatric PSD.

Evidence of Hematoma Prevention After Facelift.

Hematoma is a common complication after facelift procedures. Multiple factors have been shown to increase the risk of hematoma formation, such as male gender, anticoagulant medication use, perioperative hypertension, increased intrathoracic pressure, and operative technique. The purpose of this manuscript is to provide an overview of existing literature to provide surgeons with evidence-based recommendations on how to minimize hematoma risk during facelift surgery. A literature search for hematoma and facelift surgery was performed that identified 478 unique manuscripts. Abstracts were reviewed, excluding articles not describing facelift surgery, those written before 1970, studies with a sample size of fewer than 5 patients, non-English studies, and those that did not provide postoperative hematoma rates. Forty-five articles were included in this text, with their recommendations. Measures such as the prophylactic management of pain, nausea, and hypertension, the use of fibrin glue tissue sealants, the use of local anesthesia rather than general anesthesia, and strict blood pressure control of at least <140 mmHg were found to significantly reduce hematoma formation. Quilting sutures has shown benefit in some high-risk patients. Measures such as drains, compression dressings, perioperative use of selective serotonin reuptake inhibitors, and perioperative steroids had no significant effect on hematoma formation. In addition to appropriate patient selection and careful intraoperative hemostasis, many adjunct measures have been shown to reduce postoperative hematoma formation in facelift procedures.

Fibrin glue in managing intractable gingival bleeding in patients with inherited bleeding disorders-a quasi-experimental pilot study.

This study presents the clinical outcomes of using inhouse prepared fibrin glue for controlling gingival bleeding in patients with inherited bleeding disorders (IBD). The objective of the study was to assess the reduction in transfusion days and improvement in compliance for dental evaluation over a one-year period in a low-to-middle-income country. The quasiexperimental pilot study included 40 IBD patients with gingival bleeding. These were divided into two groups: Group A received fibrin glue (n=20), while Group B did not (n=20). The study compared outcome metrics, including the number of treatment days and blood components transfused, using non-parametric tests with a significance threshold of p<0.05. Results showed that Group A required fewer blood components (n=154) as compared to Group B (n=204) (p<0.001). Patients in Group A with Glanzmann thrombasthenia (GT) had a shorter treatment duration (one day) than those in group B (three days) (p<0.01). In conclusion, the application of fibrin glue effectively managed intractable gingival bleeding in IBD patients.

Recurrence of cerebrospinal fluid-venous fistulas at different spinal levels following transvenous embolisation or blood/fibrin glue patching.

AIM OF THE STUDY: This study presents cases of recurrent cerebrospinal fluid-venous fistulas (CVFs) de novo at a different spinal level following successful treatment of initial CVFs. The aim was to highlight this rarely described phenomenon and report the clinical and imaging features after initial treatment, providing insights into the dynamics of recurrent CVFs. CLINICAL RATIONALE FOR THE STUDY: Understanding the course of CVFs post-treatment is crucial for optimising patient management, especially when symptoms persist or recur. MATERIAL AND METHODS: We performed a retrospective chart review of all patients with recurrent CVFs at a different level after treatment of their initial CVF at our institution. Clinical and imaging records were reviewed and summarised, including Bern score features on brain magnetic resonance imaging (MRI) before and after treatment. RESULTS: Four patients with five recurrent CVFs were identified. Recurrent or persistent symptoms encouraged subsequent brain MRI scans, which revealed different outcomes: i.e. persistence, or improvement, or complete resolution of abnormal findings. Initial positive responses included improvement of the pachymeningeal enhancement and venous sinus distension. These improvements were reversed when recurrent symptoms arose, which was also correlated with changes in the Bern score. CONCLUSIONS AND CLINICAL IMPLICATIONS: Recognising the factors of CVF recurrence is crucial for comprehensive management. This study underlines the significance of repeated evaluation of persistent or recurring symptoms of CSF leak after treatment for CVFs.

[Choanoplasty in children of the first year of life: new opportunities and rehabilitation without stents]. / Khoanoplastika u detei pervogo goda zhizni: novye vozmozhnosti i reabilitatsiya bez stentov.

The article presents literature and our own data on surgical treatment and options for solving the problem of restenosis for congenital choanal atresia in children under one year of age. A new stentless choanoplasty technique using fibrin glue for fixation of posterior septal flaps is presented. This method has patent No. 2789967 dated February 14, 2023. OBJECTIVE: Evaluation of the effectiveness of the choanoplasty method using fibrin glue for fixation of flaps without the use of a stent in children of the first year of life with choanal atresia. MATERIAL AND METHODS: For the period from 2019 to 2023, a team of authors in the Department of Otorhinolaryngology of the Veltishchev Research Clinical Institute of Pediatrics and Pediatric Surgery operated on 34 patients under the age of one year with a diagnosis of choanal atresia using this choanoplasty technique. RESULTS: The results of this new surgical technique using fibrin glue are presented. Endoscopy of the nasal cavity and choanal area in all 34 patients during follow-up (from 1 to 2 years) showed no signs of restenosis. CONCLUSION: The proposed method of choanoplasty without the use of stents with fixation of mucosal flaps with fibrin glue has proven itself well and can be used in children at any age, can be one of the ways to solve the problem of restenosis and seems to us to be the method of choice in the treatment of choanal atresia.

A Randomized Controlled Trial of Fibrin Glue to Prevent Bleeding After Gastric Endoscopic Submucosal Dissection.

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

Risk factors for lymphorrhea and lymphocele after radical prostatectomy: a retrospective case-control study.

PURPOSE: To investigate the risk factors for postoperative lymphorrhea or/and lymphocele (PLL) in patients undergoing radical prostatectomy (RP). MATERIALS AND METHODS: The clinical data of 606 patients were retrospectively collected. The receiver operating characteristic (ROC) curve was utilized to identify the optimal cutoff value. Multivariable logistic regression analysis was used to screen the independent predictors of PLL. RESULTS: Univariate analysis showed that nine factors differed between the PLL and non-PLL group. Multivariable logistic regression analysis showed that low preoperative fibrinogen level, extraperitoneal surgery, robot-assisted laparoscopic radical prostatectomy (RALRP), and hypoalbuminemia were risk factors and the use of fibrin glue was a protective factor. Correlation analysis showed that the scope of LN dissection (LND) and number of lymph nodes (LNs) dissected were positively correlated with PLL in the extraperitoneal approach, but were not significantly correlated with PLL in the transperitoneal approach. The use of fibrin glue was negatively associated with PLL in the overall procedure and the extraperitoneal approach, but not significantly so in the transperitoneal approach. Comparison of LNs clearance between the two surgical approaches revealed that the extent of LND and number of LNs dissected in the extraperitoneal approach were less than in the transperitoneal approach. CONCLUSION: During RALRP, more attention should be paid to fully clotting the broken end of lymphatic vessels. The use of fibrin glue could reduce the probability of PLL. The extent of LND or number of LNs dissected were positively correlated with PLL in the extraperitoneal approach.

Factors affecting polyglycolic acid sheet engraftment success for covering mucosal defects from head and neck surgery.

BACKGROUND: Polyglycolic acid (PGA) sheets have been used with fibrin glue to cover extensive mucosal defects in oral and pharyngeal surgery; however, the sheets can fall off before wound healing is completed. Hence, prolonged fasting is often recommended in such patients. However, there are few studies on the factors that shape PGA sheet engraftment. We studied sheet engraftment rates considering these factors. METHODS: All consecutive cases of oral surgery in 2013-21 in which the defect was covered with fibrin glue and Neoveil® or Neoveil Nano® PGA sheets were identified. The loss of all sheets was defined as an engraftment failure. Multiple logistic regression analysis was conducted to identify whether the PGA-sheet type, application site, defect size and postoperative fasting duration predicted engraftment. RESULTS: Overall, 137 patients were identified (mean age, 73 years; 57% male). The surgeries were conducted with Neoveil® in 66% of the patients; the most common site was the buccal mucosa (25%), and the mean defect size and fasting duration were 709 mm2 and 4 days, respectively. The engraftment rate was 76%. Neoveil Nano® PGA sheets were associated with a 2.8-fold better engraftment rate than Neoveil® (univariate: 87 vs. 70%, P = 0.032; multivariate: 95% confidence intervals = 1.067-7.410, P = 0.036). Other variables, including fasting duration, were not predictive of engraftment. CONCLUSIONS: This is the largest case series of patients with head and neck cancer who underwent fibrin glue-PGA sheet defect coverage. The fasting duration did not influence engraftment. Therefore, early oral intake is not contraindicated in such patients.

Autological platelet-rich fibrin sealant for anterior horseshoe anal fistula in female patient: A video vignette.

INTRODUCTION: Nowadays many techniques have been developed for the treatment of complex anorectal fistulas. Biological substances are used for minimally invasive treatment of anorectal fistulas, especially for complex anal fistulas. Insertion of autological fibrin substance into the fistula tract is one of the types of such procedures. CLINICAL CASE: Here, we present a case of insertion of platelet-rich fibrin sealant into a horseshoe fistula in a female patient. The follow-up period was 10 months with no signs of clinical or MRI recurrence.

Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery.

BACKGROUND: Postoperative pancreatic fistula (POPF) is one of the most frequent and potentially life-threatening complications following pancreatic surgery. Fibrin sealants have been used in some centres to reduce POPF rate. However, the use of fibrin sealant during pancreatic surgery is controversial. This is an update of a Cochrane Review last published in 2020. OBJECTIVES: To evaluate the benefits and harms of fibrin sealant use for the prevention of POPF (grade B or C) in people undergoing pancreatic surgery compared to no fibrin sealant use. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, two other databases, and five trials registers on 09 March 2023, together with reference checking, citation searching, and contacting study authors to identify additional studies. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) that compared fibrin sealant (fibrin glue or fibrin sealant patch) versus control (no fibrin sealant or placebo) in people undergoing pancreatic surgery. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 14 RCTs, randomising 1989 participants, comparing fibrin sealant use versus no fibrin sealant use for different locations: stump closure reinforcement (eight trials), pancreatic anastomosis reinforcement (five trials), or main pancreatic duct occlusion (two trials). Six RCTs were carried out in single centres; two in dual centres; and six in multiple centres. One RCT was conducted in Australia; one in Austria; two in France; three in Italy; one in Japan; two in the Netherlands; two in South Korea; and two in the USA. The mean age of the participants ranged from 50.0 years to 66.5 years. All RCTs were at high risk of bias. Application of fibrin sealants to pancreatic stump closure reinforcement after distal pancreatectomy We included eight RCTs involving 1119 participants: 559 were randomised to the fibrin sealant group and 560 to the control group after distal pancreatectomy. Fibrin sealant use may result in little to no difference in the rate of POPF (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.73 to 1.21; 5 studies, 1002 participants; low-certainty evidence) and overall postoperative morbidity (RR 1.20, 95% CI 0.98 to 1.48; 4 studies, 893 participants; low-certainty evidence). After fibrin sealant use, approximately 199 people (155 to 256 people) out of 1000 developed POPF compared with 212 people out of 1000 when no fibrin sealant was used. The evidence is very uncertain about the effect of fibrin sealant use on postoperative mortality (Peto odds ratio (OR) 0.39, 95% CI 0.12 to 1.29; 7 studies, 1051 participants; very low-certainty evidence) and total length of hospital stay (mean difference (MD) 0.99 days, 95% CI -1.83 to 3.82; 2 studies, 371 participants; very low-certainty evidence). Fibrin sealant use may reduce the reoperation rate slightly (RR 0.40, 95% CI 0.18 to 0.90; 3 studies, 623 participants; low-certainty evidence). Serious adverse events were reported in five studies (732 participants), and there were no serious adverse events related to fibrin sealant use (low-certainty evidence). The studies did not report quality of life or cost-effectiveness. Application of fibrin sealants to pancreatic anastomosis reinforcement after pancreaticoduodenectomy We included five RCTs involving 519 participants: 248 were randomised to the fibrin sealant group and 271 to the control group after pancreaticoduodenectomy. The evidence is very uncertain about the effect of fibrin sealant use on the rate of POPF (RR 1.34, 95% CI 0.72 to 2.48; 3 studies, 323 participants; very low-certainty evidence), postoperative mortality (Peto OR 0.24, 95% CI 0.05 to 1.06; 5 studies, 517 participants; very low-certainty evidence), reoperation rate (RR 0.74, 95% CI 0.33 to 1.66; 3 studies, 323 participants; very low-certainty evidence), and total hospital cost (MD -1489.00 US dollars, 95% CI -3256.08 to 278.08; 1 study, 124 participants; very low-certainty evidence). After fibrin sealant use, approximately 130 people (70 to 240 people) out of 1000 developed POPF compared with 97 people out of 1000 when no fibrin sealant was used. Fibrin sealant use may result in little to no difference both in overall postoperative morbidity (RR 1.02, 95% CI 0.87 to 1.19; 4 studies, 447 participants; low-certainty evidence) and in total length of hospital stay (MD -0.33 days, 95% CI -2.30 to 1.63; 4 studies, 447 participants; low-certainty evidence). Serious adverse events were reported in two studies (194 participants), and there were no serious adverse events related to fibrin sealant use (very low-certainty evidence). The studies did not report quality of life. Application of fibrin sealants to pancreatic duct occlusion after pancreaticoduodenectomy We included two RCTs involving 351 participants: 188 were randomised to the fibrin sealant group and 163 to the control group after pancreaticoduodenectomy. The evidence is very uncertain about the effect of fibrin sealant use on postoperative mortality (Peto OR 1.41, 95% CI 0.63 to 3.13; 2 studies, 351 participants; very low-certainty evidence), overall postoperative morbidity (RR 1.16, 95% CI 0.67 to 2.02; 2 studies, 351 participants; very low-certainty evidence), and reoperation rate (RR 0.85, 95% CI 0.52 to 1.41; 2 studies, 351 participants; very low-certainty evidence). Fibrin sealant use may result in little to no difference in the total length of hospital stay (median 16 to 17 days versus 17 days; 2 studies, 351 participants; low-certainty evidence). Serious adverse events were reported in one study (169 participants; low-certainty evidence): more participants developed diabetes mellitus when fibrin sealants were applied to pancreatic duct occlusion, both at three months' follow-up (33.7% fibrin sealant group versus 10.8% control group; 29 participants versus 9 participants) and 12 months' follow-up (33.7% fibrin sealant group versus 14.5% control group; 29 participants versus 12 participants). The studies did not report POPF, quality of life, or cost-effectiveness. AUTHORS' CONCLUSIONS: Based on the current available evidence, fibrin sealant use may result in little to no difference in the rate of POPF in people undergoing distal pancreatectomy. The evidence is very uncertain about the effect of fibrin sealant use on the rate of POPF in people undergoing pancreaticoduodenectomy. The effect of fibrin sealant use on postoperative mortality is uncertain in people undergoing either distal pancreatectomy or pancreaticoduodenectomy.

Intraocular Fibrin Glue to Lower the Risk of Postoperative Vitreous Hemorrhage After Diabetic Pars Plana Vitrectomy.

PURPOSE: To investigate the use of intraocular fibrin glue to lower the risk of vitreous hemorrhage (VH) after pars plana vitrectomy (PPV) in eyes with diabetic VH or traction retinal detachment. METHODS: A matched, case-control, single-surgeon, pilot study of patients undergoing PPV for diabetic VH or traction retinal detachment with versus without fibrin glue was performed. RESULTS: Thirty-nine patients (13 glue and 26 control patients) were included. In the glue group, mean (SD) logarithm of the minimum angle of resolution visual acuity (Snellen) significantly improved from 1.53 (0.6) (20/678) to 0.99 (0.9) (20/195) at postoperative month 6 ( P = 0.03). In the control group, mean logarithm of the minimum angle of resolution visual acuity also improved from 1.45 (0.8) (20/564) to 1.17 (0.9) (20/296) at postoperative Month 6 ( P = 0.3). Persistent post-PPV VH was similar between the 2 groups (15.4% in both groups, P > 0.99). However, early recurrent VH (<3 months post-PPV) was seen in 34.6% in the control group and none in the glue group ( P = 0.02). No intraocular inflammatory events were seen in the glue group. CONCLUSION: Intraocular fibrin glue may be a safe adjuvant in diabetic vitrectomy and may reduce the rate of early recurrent postoperative VH.

NHS-POx-loaded patch versus fibrin sealant patch in a porcine robotic liver bleeding model.

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.

Fibrin Glue is a Viable Alternative to Fat Graft for Interposition After Tarsal Coalition Resection.

BACKGROUND: Tarsal coalition is one of the most common foot and ankle pathologies in children, yet there is no consensus regarding what to interpose after resection. Fibrin glue could be considered, but the literature comparing fibrin glue to other interposition types is sparse. The purpose of this study was to evaluate the effectiveness of fibrin glue for interposition compared with fat graft by analyzing the rate of coalition recurrence and wound complications. We hypothesized that fibrin glue would have similar rates of coalition recurrence and fewer wound complications compared with fat graft interposition. METHODS: A retrospective cohort study was performed examining all patients who underwent a tarsal coalition resection at a free-standing children's hospital in the United States from 2000 to 2021. Only patients undergoing isolated primary tarsal coalition resection with interposition of fibrin glue or fat graft were included. Wound complications were defined as any concern for an incision site that prompted the use of antibiotics. Comparative analyses were conducted using χ 2 and Fisher exact test to examine relationships among interposition type, coalition recurrence, and wound complications. RESULTS: One hundred twenty-two tarsal coalition resections met our inclusion criteria. Fibrin glue was used for interposition in 29 cases and fat graft was used in 93 cases. The difference in the coalition recurrence rate between fibrin glue and fat graft interposition was not statistically significant (6.9% vs. 4.3%, P =0.627). The difference in wound complication rate between fibrin glue and fat graft interposition was not statistically significant (3.4% vs 7.5%, P = 0.679). CONCLUSION: Fibrin glue interposition after tarsal coalition resection is a viable alternative to fat graft interposition. Fibrin glue has similar rates of coalition recurrence and wound complications when compared with fat grafts. Given our results and the lack of tissue harvesting required with fibrin glue, fibrin glue may be superior to fat grafts for interposition after tarsal coalition resection. LEVEL OF EVIDENCE: Level III, a retrospective comparative study between treatment groups.

Repair of ventricular wall by pericranial flap: a valuable option?

Ventricular walls penetration frequently occurs in periventricular gliomas surgery. Even when aimed at maximal tumor resection, it can lead to several complications, including CSF leak, delayed wound healing and, potentially, distant tumor dissemination, with a negative impact on overall survival. Several authors have claimed damaged ventricular walls always need repair, especially when the additional use of intrathecal chemotherapy is scheduled. Fibrin sponge has been consistently used in the past to address small ventricular walls defects but more recently attention has been focused on TachoSilTM, that seems to be a valid alternative to close up to 1.5 cm gaps. After an accurate review of literature, we were unable to find any report describing the use of autologous pericranium to the same aim. We report the case of a 54 years-old patient who presented with symptoms of intracranial hypotension four weeks after his last surgery (performed at another Institution) for a relapsing right frontal grade III astrocytoma,. Pre-operative MRI showed a huge gap in the roof of the right frontal ventricular horn, associated to a large subdural hygroma and a massive subcutaneous CSF collection. The gap was repaired using a layer of autologous pericranium, sutured by pial stitches to the surrounding brain and reinforced by fibrin glue. Full and permanent leak sealing was obtained within the next 2 weeks, but patient immediately and fully recovered from his symptoms. Although limited by the single case experience, we believe that pericranium might be considered as an alternative to artificial materials in cases of large ventricular walls openings, being easily intraoperatively retrievable, granting maximal biocompatibility, not significantly impacting on surgery duration and overall costs.

Use of tissue sealant patch (TachoSil) in the management of cerebrospinal fluid leaks after anterior cervical spine discectomy and fusion.

PURPOSE: The purpose of this study was to evaluate a fast, sutureless technique to repair anterior cervical dural tears. Anterior cervical discectomy and fusion (ACDF) is a commonly performed procedure for the treatment of cervical degenerative diseases. Although uncommon, incidental durotomy with cerebrospinal fluid (CSF) leak during ACDF is a potentially serious complication. Yet, its technical management for the prevention of CSF leak is controversial. METHODS: Between September 2012 and June 2018 we encountered seven cases (2 female/5 male) presenting with intraoperative CSF leaks secondary to incidental dural tears during ACDF surgery. All the cases were surgically treated using a topical fibrin sealant patch (TachoSil) with high adesive strength and fibrin glue (Tisseel). Intraoperative source of leakage, time to leakage control, quantity of Sealant Sponge used and postoperative complications were evaluated. RESULTS: Dural tears were tipically the result of dissection of adherent posterior longitudinal ligament and/or calcified disc from the cervical dural sac to allow full decompression of the spinal cord. Effective repair of dural tear defined as cessation of CSF leak after topical sealant agents application was achieved no later than one minute in all cases. Evident clinical and/or radiological postoperative CSF leak was used to determine the patient's postoperative result. Postoperative CSF leak was not evident during a minimum 6 months follow up. CONCLUSIONS: In the present study, we have reported our experience with a new sealing technique to manage CSF leaks from iatrogenic cervical dural lacerations. Tachosil tissue sealant patch is a rapid sutureless technique that may help in repairing introperatively incidental dural tears, thus reducing the risk of postoperative CSF leaks. To our knowledge, this is the first series to report the use of Tachosil adhesive sealant patch for the treatment of incidental dural tears during anterior cervical discectomy.