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Hemopatch^® is effective and safe to use: real-world data from a prospective European registry study.

ABSTRACT: Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch^® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch^® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch^® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch^® registry shows that Hemopatch^® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch^® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.

SUBMITTER: Lombardo C

PROVIDER: S-EPMC9481486 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Hemopatch® is effective and safe to use: real-world data from a prospective European registry study.

Lombardo Carlo C Lopez-Ben Santiago S Boggi Ugo U Gutowski Piotr P Hrbac Tomas T Krska Lukas L Marquez-Rivas Javier J Russello Domenico D York Elisa E Zacharias Mario M

Updates in surgery 20220820 5

Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had ...[more]

PMID: 35986865

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Project description:BackgroundThere has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation.ObjectiveTo evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy.MethodsData were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line.ResultsFinally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases.ConclusionsSingle-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

Project description:ObjectivesVulvovaginal candidiasis is common in women, causing discomfort and negatively impacting quality of life. Canesten® is an established over-the-counter brand. Its clotrimazole/fluconazole-based products, available in a variety of different formulations, have demonstrated efficacy and safety in the treatment of women with thrush/vaginal yeast infection in randomized trials. This real-world evidence study, conducted in the United Kingdom and Canada, aimed to provide consumer-important information on the benefits of Canesten, collecting retrospective information from consumers about their recent experience with the product.MethodsEligible participants were female, aged 18-60 years, and had experienced at least one episode of vaginal thrush (United Kingdom)/vaginal yeast infection (Canada) during the previous 6 months for which they had used at least one of the six Canesten products. Participants completed an online questionnaire eliciting information on the speed of onset of symptom relief, impact on quality of life, and product attributes/satisfaction.ResultsOver 90% of respondents reported improvements in symptoms and quality of life after starting treatment with a Canesten product. Improvements in symptoms within 4 h of the first time of use were perceived by 42% of consumers; 76%-88% reported symptomatic relief within 1 day. The perceived general speed of onset of symptomatic relief with a Canesten oral product (1-2 days) was slightly longer than that with a Canesten topical/intra-vaginal product (⩽1 day). Most users of Canesten single (90%) and dual product treatments (95%) reported that the products started to work from the first application. Women experiencing both internal and external symptoms of thrush/vaginal yeast infection reported Canesten dual product formulations to provide faster symptomatic relief than single product treatments. Over 90% of respondents were satisfied with their use of a Canesten product.ConclusionCanesten was found by consumers to offer rapid relief of the symptoms of thrush/vaginal yeast infection with improvements in quality of life. Consumer satisfaction was high.

Project description:BACKGROUND & AIMS:The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS:We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS:Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS:In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

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Hemopatch^® is effective and safe to use: real-world data from a prospective European registry study.

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Hemopatch<sup>®</sup> is effective and safe to use: real-world data from a prospective European registry study.

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