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Background The serum collection under the abdominal flap is the most common complication after a lipo-abdominoplasty. The frequency of seroma increases further among obese patients, who have achieved massive weight loss after bariatric surgery. The purpose of this study is to demonstrate the effectiveness of fibrin glues with a low concentration of thrombin in reducing seroma formation after a lipo-abdominoplasty. Methods Thirty patients, that had achieved a significant weight loss after an intervention of laparoscopic adjustable gastric banding (LAGB), underwent a circular lipo-abdominoplasty at our bariatric surgery department. Patients were divided into two groups of 15 subjects each: group A underwent traditional surgery; in group B, we applied a slow-clotting variant of fibrin glue (ARTISS, Baxter) under the abdominal flap. All subjects were evaluated clinically using an ultrasound device on postoperative day 15. We considered positive for seroma, those cases with a liquid collection greater than 20 cc. Results The groups were homogeneous for age, BMI, male/female ratio, and diabetic or smoker patients. The mean hospital stay was significantly longer in group A than in group B. We found eight cases of serum collection >20 cc in group A and only one case in group B. Hematoma, umbilicus necrosis, and surgical site infection occurred in both groups, but overall complication rate was lower in group B. Conclusions The use of a fibrin glue with a low concentration of thrombin could be useful during wound closure and may decrease seroma formation in postbariatric patients undergoing lipo-abdominoplasty.

Purpose The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. Methods This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient’s group allocation. Results Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0–4) vs. 1.9 ± 1.41 (range 0–5) blood units; P  = 0.04]. No major treatment-related adverse events were recorded in the study. Conclusions This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. Clinical relevance A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. Level of evidence II.

DNA origami-based nanorobot presents thrombin to cause tumor infarction after specific recognition of a tumor vessel marker. Nanoscale robots have potential as intelligent drug delivery systems that respond to molecular triggers 1 , 2 , 3 , 4 . Using DNA origami we constructed an autonomous DNA robot programmed to transport payloads and present them specifically in tumors. Our nanorobot is functionalized on the outside with a DNA aptamer that binds nucleolin, a protein specifically expressed on tumor-associated endothelial cells 5 , and the blood coagulation protease thrombin within its inner cavity. The nucleolin-targeting aptamer serves both as a targeting domain and as a molecular trigger for the mechanical opening of the DNA nanorobot. The thrombin inside is thus exposed and activates coagulation at the tumor site. Using tumor-bearing mouse models, we demonstrate that intravenously injected DNA nanorobots deliver thrombin specifically to tumor-associated blood vessels and induce intravascular thrombosis, resulting in tumor necrosis and inhibition of tumor growth. The nanorobot proved safe and immunologically inert in mice and Bama miniature pigs. Our data show that DNA nanorobots represent a promising strategy for precise drug delivery in cancer therapy.

Management of postcatheterization femoral artery pseudoaneurysm (FAP) is problematic. Ultrasound-guided compression (UGC) is painful and cumbersome. Thrombin injection is costly and may cause thromboembolism. Ultrasound-guided para-aneurysmal saline injection (PASI) has been described but was never compared against other treatment methods of FAP. We aimed at comparing the success rate and complications of PASI versus UGC. We randomly assigned 80 patients with postcatheterization FAPs to either UGC (40 patients) or PASI (40 patients). We compared the 2 procedures regarding successful obliteration of the FAP, incidence of vasovagal attacks, procedure time, discontinuation of antiplatelet and/or anticoagulants, and the Doppler waveform in the ipsilateral pedal arteries at the end of the procedure. There was no significant difference between patients in both groups regarding clinical and vascular duplex data. The mean durations of UGC and PASI procedures were 58.14 ± 28.45 and 30.33 ± 8.56 minutes, respectively (p = 0.045). Vasovagal attacks were reported in 10 (25%) and 2 patients (5%) treated with UGC and PASI, respectively (p = 0.05). All patients in both groups had triphasic Doppler waveform in the infrapopliteal arteries before and after the procedure. The primary and final success rates were 75%, 92.5%, 87.5%, and 95% for UGC and PASI, respectively (p = 0.43). In successfully treated patients, there was no reperfusion of the FAP in the follow-up studies (days 1 and 7) in both groups. In conclusion, ultrasound-guided PASI is an effective method for the treatment of FAP. Compared with UGC, PASI is faster, less likely to cause vasovagal reactions, and can be more convenient to patients and physicians.

Background Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies. Although typically asymptomatic, lymphoceles can superinfect requiring medical or surgical intervention. A single center randomized controlled trial provided first evidence, that a collagen-fibrin patch (Tachosil®) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy. Methods/Design We will perform a multicentre, blinded, randomized, controlled trial comprising 140 women with gynecologic malignancies undergoing pelvic lymphadenectomy. Women will be randomly allocated to Tachosil® application or no application. Primary outcome is efficacy, defined as lymphocele CTCAE 4.03 grade ≥2 within four weeks after surgery. Secondary outcomes are asymptomatic lymphocele verified by ultrasound, medical or surgical intervention. Assuming a two-sided 5% significance level, a power of 80%, and a drop out rate of 10%, a sample size of 68 patients per group was calculated to detect a 66% absolute decrease in symptomatic lymphoceles. Discussion We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy. Trial registration This study is registered at ClinicalTrials.gov ( NCT01470677 , protocol ID: TACHO-1). This study is registered at the EudraCT database (EudraCT number: 2011-003115-34).

The treatment of diabetic ulcer (DU) remains a major clinical challenge due to the complex wound-healing milieu that features chronic wounds, impaired angiogenesis, persistent pain, bacterial infection, and exacerbated inflammation. A strategy that effectively targets all these issues has proven elusive. Herein, we use a smart black phosphorus (BP)-based gel with the characteristics of rapid formation and near-infrared light (NIR) responsiveness to address these problems. The in situ sprayed BP-based gel could act as 1) a temporary, biomimetic “skin” to temporarily shield the tissue from the external environment and accelerate chronic wound healing by promoting the proliferation of endothelial cells, vascularization, and angiogenesis and 2) a drug “reservoir” to store therapeutic BP and pain-relieving lidocaine hydrochloride (Lid). Within several minutes of NIR laser irradiation, the BP-based gel generates local heat to accelerate microcirculatory blood flow, mediate the release of loaded Lid for “on-demand” pain relief, eliminate bacteria, and reduce inflammation. Therefore, our study not only introduces a concept of in situ sprayed, NIR-responsive pain relief gel targeting the challengingwound-healing milieu in diabetes but also provides a proof-of-concept application of BP-based materials in DU treatment.

Topical bovine thrombin has been associated with immune responses and anecdotal reports of coagulopathy. This open-label study assessed the impact on clinical hemostasis of human antibodies to bovine thrombin (aBT) or factor V/Va (aBV/Va) in response to topical bovine thrombin (THROMBIN-JMI) in patients both with and without preexisting anti-bovine antibodies. Noninferiority analysis assessed primary endpoint for mean shift from baseline activated partial thromboplastin time (aPTT) at 48 hours postsurgery; secondary endpoints included changes from baseline antibodies/titers and coagulation parameters through 8 weeks postsurgery. A total of 550 patients underwent surgery with THROMBIN-JMI utilized at investigator’s discretion. Adjusted mean aPTT change in (+)aBT/(+)THROMBIN-JMI cohort was greater than (-)aBT/(-)THROMBIN-JMI cohort; 4.67-second upper confidence bound exceeded 4.5-second margin (based on assumed mean aPTT of 30 seconds) and noninferiority was not met. Post hoc analysis indicated noninferiority would have been met had noninferiority margin been set prior at relative 15% of actual baseline aPTT. Antibodies/titers were unchanged by THROMBIN-JMI exposure 48 hours postsurgery and unrelated to postsurgical changes in coagulation. Thus, THROMBIN-JMI exposure in patients with/without preexisting aBT or aBV/Va does not alter hemostasis.

Previous studies demonstrated that thrombin is an important factor in brain injury after intracerebral hemorrhage. This study investigated the effect of thrombin on hydrocephalus development in a rat intraventricular hemorrhage (IVH) model. There were three parts in this study. First, male Sprague–Dawley rats had an injection of 200 μL saline, autologous blood or heparinized blood, into the right lateral ventricle. Second, rats had an injection of 50 μL saline or 3U thrombin into the right lateral ventricle. Third, rats had an injection of thrombin (3U) with a protease-activated receptor-1 (PAR-1) antagonist, SCH79797 (0.15 nmol), or vehicle into the right lateral ventricle. Lateral ventricle volumes were measured by magnetic resonance imaging and the brains were used for immunohistochemistry and western blot analyses. Intraventricular injection of autologous blood induced hydrocephalus from day 1 to 28. Heparinized blood injection resulted in less hydrocephalus at all time points compared with blood injection alone (P<0.05). Intraventricular injection of thrombin caused significant hydrocephalus, ventricular wall damage, and periventricular blood–brain barrier disruption. Thrombin-induced hydrocephalus was reduced by co-injection of the PAR-1 antagonist SCH79797 (P<0.05). In conclusion, thrombin contributes to hydrocephalus development after IVH and thrombin-induced hydrocephalus is through PAR-1.

Drugs that induce thrombosis in the tumour vasculature have not resulted in long-term tumour eradication owing to tumour regrowth from tissue in the surviving rim of the tumour, where tumour cells can derive nutrients from adjacent non-tumoral blood vessels and tissues. Here, we report the performance of a combination of tumour-infarction therapy and chemotherapy, delivered via chitosan-based nanoparticles decorated with a tumour-homing peptide targeting fibrin–fibronectin complexes overexpressed on tumour-vessel walls and in tumour stroma, and encapsulating the coagulation-inducing protease thrombin and the chemotherapeutic doxorubicin. Systemic administration of the nanoparticles into mice and rabbits bearing subcutaneous or orthotopic tumours resulted in higher tumour growth suppression and decreased tumour recurrence than nanoparticles delivering only thrombin or doxorubicin, with histological and haematological analyses indicating an absence of detectable toxicity. The co-administration of a cytotoxic payload and a protease to elicit vascular infarction in tumours with biodegradable tumour-targeted nanoparticles represents a promising strategy for improving the therapeutic index of coagulation-based tumour therapy. The combination of tumour-infarction therapy and chemotherapy, delivered via nanoparticles decorated with a tumour-homing peptide and encapsulating thrombin and doxorubicin, outperforms the corresponding monotherapies in tumour-bearing mice and rabbits.

Active thrombin is found in the airways of patients with a variety of inflammatory lung diseases. However, whether thrombin contributes to the pathologies of these diseases is unknown, although thrombin is a potent inflammatory mediator in other organ systems. In the present study we have assessed the acute inflammatory effect of inhaled thrombin and investigated the possible receptors mediating any effects in mice. Thrombin (200–2000 U kg−1 intranasally), induced the recruitment of a small, but significant, number of neutrophils into the airways as assessed by differential counts of cells retrieved by bronchoalveolar lavage (BAL). This small response was mimicked by peptide agonists of proteinase‐activated receptor‐4 (PAR4; GYPGKF, AYPGKF; 2–20 mg kg−1), but not PAR1 (SFLLRN; 2–20 mg kg−1). By contrast, trypsin (200–2000 U kg−1) caused profound inflammation and lung damage. Concentrations of tumour necrosis factor‐α (TNF‐α) were elevated in BAL fluid from thrombin‐treated mice, and a TNF‐α‐neutralising antibody inhibited the influx of neutrophils in response to thrombin. Although isolated alveolar macrophages appeared to express PAR1‐ and PAR4‐immunoreactivity, these cells failed to release TNF‐α above baseline levels in response to thrombin, trypsin or any of the peptide PAR agonists. Neither thrombin (2000 U kg−1) nor trypsin (200 U kg−1) modified the airway neutrophilia in response to intranasal bacterial lipopolysaccharide (LPS; 100 μg kg−1). In conclusion, exogenous thrombin has only a modest acute inflammatory action in the lung that appears to be mediated by PAR4 and involve release of TNF‐α from an unknown source. British Journal of Pharmacology (2004) 143, 269–275. doi:10.1038/sj.bjp.0705926