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Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

ABSTRACT: BACKGROUND:This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures. METHODS:This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handling characteristics of the suture. Patients and professionals used the Patient-Observer-Scar-Assessment-Scale (POSAS) to rate scar quality. Adverse events were monitored until 3?months postoperatively. RESULTS:Handling characteristics of Novosyn® Quick were in median rated very good by both general surgeons and paediatric surgeons. Patient components of POSAS (six questions; ten-level Likert scale; best possible score six) scored in median (range) 8.5 (6-28) in the paediatric group versus 12 (6-38) in the adult group, P =?0.01. Patients` overall opinions of POSAS were similar in both groups [mean (SD), 1.86 (0.99) in the paediatric group versus 2.08 (1.35) in the adult group, P =?0.3536]. Observer component of POSAS (six parameters; ten-level numeric rating scale, best possible score six) scored comparably in both groups [median (range), 8 (6-29) in the paediatric group versus 10 (6-28) in the adult group, P =?0.1403]. Observers overall opinion of POSAS favoured the paediatric patients group [mean (SD), 1.48 (0.61) versus 1.92 (1.06) in the adult group, P =?0.0131]. Adverse events in relation to wound healing were not observed in both patient groups. CONCLUSIONS:Our findings indicate, that Novosyn® Quick is safe and reliable for skin closure in adults and paediatric patients and can be regarded as a viable alternative to Vicryl® Rapide. TRIAL REGISTRATION:This trial was registered prospectively with ClinicalTrials.gov under the registration number NCT02680886 on 5 February 2016. The trial was approved by the Institutional Review Boards of both study locations (France: CCTIRS N° 16-103 and CNIL:MMS/CWR/AR163920; Germany: 398/15).

SUBMITTER: Gfroerer S

PROVIDER: S-EPMC6498545 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

Gfroerer Stefan S Baumann Petra P Schwalbach Anne-Kathrin AK Smirnoff Alexandre A

BMC surgery 20190502 1

<h4>Background</h4>This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures.<h4>Methods</h4>This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handlin ...[more]

PMID: 31046730

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Project description:INTRODUCTION:In real-life practice, asthma remains poorly controlled, with a considerable burden on patients' quality of life. Budesonide/formoterol (B/F) Easyhaler® has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler®, but no real-life comparisons are yet available in patients switching from B/F Turbuhaler® to B/F Easyhaler®. METHODS:The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler® to B/F Easyhaler®. At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler®. The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching. RESULTS:A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler® demonstrated non-inferiority to B/F Turbuhaler®; the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p?<?0.0001) and met the non-inferiority criteria of B/F Easyhaler® being greater than - 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler® treatment and lung function remained stable across the treatment period. B/F Easyhaler® was easy to learn and prepare for use. CONCLUSION:This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler® to B/F Easyhaler®. A further study with direct comparison between treatments could add to the understanding of inhaler switch. FUNDING:Orion Corporation, Orion Pharma.

Project description:BackgroundA multicenter observational study was conducted in Italy to assess the safety of micafungin in the daily clinical practice for the treatment of proven and suspected invasive candidiasis (IC), as well as to describe rates of clinical response to micafungin treatment.MethodsFrom October 2010 to March 2012, data from consecutive eligible neonate, pediatric, and adult patients treated with micafungin for a proven or suspected IC were collected. Patients were deemed as eligible if they or their parents signed an informed consent. The study endpoints were to assess safety of micafungin in the treatment of both proven and suspected IC, and to describe rates of clinical response to micafungin treatment. Clinical response was assessed at the end of micafungin treatment (EOMT) and defined as favorable (complete or partial resolution of signs and symptoms) or unfavorable (stability or progression).ResultsDuring the study period, 108 patients with proven or suspected IC were enrolled. Thirty-six out of 108 patients (33%) were < 18 year-old (median 1 year), whereas 72 (67%) were ? 18 year-old (median 71 years). Neonates in NICU accounted for 36% of pediatric patients, with the majority of them (54%) being extremely low birth weight (ELBW) newborns. Fifty-eight out of 108 patients (54%) received micafungin for a proven IC, whereas 50/108 patients (46%) were treated for a suspected IC. Among proven IC, candidemia accounted for the majority of events (54/58, 93%), with Candida albicans (35/58, 60%) as the most frequently isolated species. Therapy was discontinued due to occurrence of an adverse event in 4/108 subjects (4%). No pediatric patient had treatment interruption because of adverse events. A 67% favorable response rate was observed at EOMT. No age-, species-, underlying conditions- or ward-related differences of favorable response were observed. Survival at EOMT was 90% (97/108 patients), with rates of 97% (35/36) and 86% (62/72) among children and adults, respectively.ConclusionsMicafungin was well tolerated in a heterogeneous real world population with a bimodal age distribution. A high rate of favorable response to micafungin treatment was reported in both proven and suspected IC.

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Project description:Background and aimsCardiac arrest (CA) in children is a major public health problem. Thanks to advances in cardiopulmonary resuscitation (CPR) guidelines and teaching skills, results in children have improved. However, pediatric CA has a very high mortality. In the treatment of in-hospital CA there are still multiple controversies. The objective of this study is to develop a multicenter and international registry of in-hospital pediatric cardiac arrest including the diversity of management in different clinical and social contexts. Participation in this register will enable the evaluation of the diagnosis of CA, CPR and post-resuscitation care and its influence in survival and neurological prognosis.MethodsAn intrahospital CA data recording protocol has been designed following the Utstein model. Database is hosted according to European legislation regarding patient data protection. It is drafted in English and Spanish. Invitation to participate has been sent to Spanish, European and Latinamerican hospitals. Variables included, asses hospital characteristics, the resuscitation team, patient's demographics and background, CPR, post-resuscitation care, mortality, survival and long-term evolution. Survival at hospital discharge will be evaluated as a primary outcome and survival with good neurological status as a secondary outcome, analyzing the different factors involved in them. The study design is prospective, observational registry of a cohort of pediatric CA.ConclusionsThis study represents the development of a registry of in-hospital CA in childhood. Its development will provide access to CPR data in different hospital settings and will allow the analysis of current controversies in the treatment of pediatric CA and post-resuscitation care. The results may contribute to the development of further international recommendations. Trial register: ClinicalTrials.gov Identifier: NCT04675918. Registered 19 December 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT04675918?cond=pediatric+cardiac+arrest&draw=2&rank=10.

Dataset Information

Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

Publications

Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

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