Dataset Information

Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded Polytetrafluoroethylene: A Randomized Clinical Trial.

ABSTRACT: Expanded polytetrafluoroethylene (ePTFE) is a widely used alloplast, but studies of augmentation of the nasal tip and nasal dorsum with ePTFE are lacking.To investigate whether attaching the conchal cartilage as shield grafts at the distal end of the graft can prevent extrusion and whether the use of ePTFE in the nasal tip can achieve a stable aesthetic outcome.A randomized clinical trial was performed from April 1, 2006, to October 31, 2008. Follow-up was completed in 2012 and 2017. The study was conducted at the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. One hundred fifty patients seeking rhinoplasty were recruited, and 129 were eligible for inclusion in the study. All the recruited patients were intent-to-treat populations who were randomized into 2 groups: an ePTFE-only group and an ePTFE with conchal cartilage group.Expanded PTFE was used for augmentation of the nasal tip and nasal dorsum in both groups. Conchal cartilage was placed above the distal end in the ePTFE with conchal cartilage group.Preoperative and postoperative standard photographs were obtained. Postoperative satisfaction and complications were evaluated.Of the 129 patients (mean age [range], 28 years [21-45 years]; 6 male and 123 female) eligible for inclusion in this study, 76 (mean age [range], 31 years [22-45 years]; 4 male and 72 female) were available for follow-up (mean [range], 106.9 months [100-131 months]) through 2017, including 39 in the ePTFE-only group and 37 in the ePTFE with conchal cartilage group. Infection occurred in 2 patients (5%) in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (infection rate [OR, 1.946; 95% CI, 0.169-22.413; P?>?.99]). Soft-tissue reaction occurred in 0 patients in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (soft-tissue reaction rate [OR, 0.000; 95% CI, 0.000-8.538; P?=?.49]). Irregularity occurred in 0 patients in the ePTFE-only group vs 3 patients (8%) in the ePTFE with conchal cartilage group (irregularity rate [OR, 0.000; 95% CI, 0.000-1.066; P?=?.11]). Extrusion occurred in neither of the 2 groups.A new technique using ePTFE alone for augmentation of the nasal tip and nasal dorsum achieved safe, attractive, and acceptable outcomes in nasal contouring and patient satisfaction. The use of conchal cartilage as a shield in the nasal tip is not necessary.1.Chinese Clinical Trial Registry identifier: ChiCTR-INR-17011101.

SUBMITTER: Gu Y

PROVIDER: S-EPMC5876884 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded Polytetrafluoroethylene: A Randomized Clinical Trial.

Gu Yifei Y Yu Wenxin W Jin Yunbo Y Chen Hui H Ma Gang G Chang Shih-Jen SJ Lin Xiaoxi X

JAMA facial plastic surgery 20180701 4

<h4>Importance</h4>Expanded polytetrafluoroethylene (ePTFE) is a widely used alloplast, but studies of augmentation of the nasal tip and nasal dorsum with ePTFE are lacking.<h4>Objective</h4>To investigate whether attaching the conchal cartilage as shield grafts at the distal end of the graft can prevent extrusion and whether the use of ePTFE in the nasal tip can achieve a stable aesthetic outcome.<h4>Design, setting, and participants</h4>A randomized clinical trial was performed from April 1, 2 ...[more]

PMID: 29470561

Similar Datasets

Project description:Background and objectivesExpanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.Design, setting, participants, & measurementsClinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment.ResultsAmong 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and β2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.ConclusionsHemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.Clinical trial registry name and registration numberA Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.

Project description:The objective of this work was to use transcriptional profiling to assess the biological activity of structurally related chemicals to define their biological similarity and with that, substantiate the validity of a read-across approach usable in risk assessment. Two case studies are presented, one with 4 short alkyl chain parabens: methyl (MP), ethyl (EP), butyl (BP), and propyl paraben (PP), as well as their main metabolite, p-Hydroxybenzoic acid (pHBA) with the assumption that PP was the target chemical; and a second one with caffeine (CA) and its main metabolites theophylline (TP), theobromine (TB) and paraxanthine (PX), where caffeine was the target chemical. The comprehensive transcriptional response of MCF7, HepG2, A549 and ICell cardyomiocytes was evaluated (TempO-Seq) after exposure to vehicle-control, each paraben or pHBA, caffeine or its metabolites, at 3 non-cytotoxic concentrations, for 6h. Differentially expressed genes (FDR ≥ 0.05, and fold change ±1.2≥) were identified for each chemical, at each dose of exposure, and used to determine similarities between them. Each of the chemicals is able to elicit changes in the expression of a number of genes, as compared to controls, particularly at the highest dose tested. Importantly, the transcriptional profile elicited by each of the parabens shares a high degree of similarities across the category members. The highest number of genes commonly affected by the parabens was found between BP and PP. The transcriptional profile of the parabens is similar to the one elicited by some estrogen receptor agonist, among other actives. Pathway enrichment analysis (MSigDB v7.0) of the transcriptional profile for each paraben indicated a significant overlap in the up- and down-regulated pathways across the four parabens.The highest similarity in biological activity was found between BP and PP. This was indicative of their biological similarity, and thus the validity of the read across among the group, with BT being the closest structural and biological analogue for PP. In the caffeine case and its main metabolites, the transcriptional profile elicited of all four compounds had a high degree of similarity across the cell types, with CA and TP being the most active. The most robust response was obtained in the cardiomyocytes with the highest transcriptional profile similarity between CA and TP. The transcriptional profile of the methylxantines is similar to the one elicited by inhibitors of phosphatidylinositol 3-kinase as well as other actives. Pathway enrichment analysis (MSigDB v7.0) of the transcriptional profile for each compound indicated a significant overlap in the up- and down-regulated pathways across the four methylxanthines. The highest similarity in biological activity was found between CA and TP, supporting the conclusion that from the group of methylxantines evaluated TP is the most appropriate analogue to read-across for CA. Overall, our results support the approach of incorporating transcriptional profiling in well-designed in vitro tests to support biological similarity driven read-across procedures and strengthening the traditional structure-based approaches useful in risk assessment.

Project description:BackgroundOxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings.Methods(1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC.ResultsThe laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood pCO2 was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with CO2 retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and SpO2. The OSNRC group had a higher mean SpO2 than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement.ConclusionThe OSNRC enhances oxygen delivery without causing CO2 retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia.Trial registrationThe trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845 ; Date of registration: 15 July 2020).

Project description:ObjectiveTo evaluate the safety and efficacy of a novel formulation of midazolam administered as a single-dose nasal spray (MDZ-NS) in the outpatient treatment of patients experiencing seizure clusters (SCs).MethodsThis was a phase III, randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov NCT01390220) with patients age ≥12 years on a stable regimen of antiepileptic drugs. Following an in-clinic test dose phase (TDP), patients entered an outpatient comparative phase (CP) and were randomized (2:1) to receive double-blind MDZ-NS 5 mg or placebo nasal spray, administered by caregivers when they experienced an SC. The primary efficacy end point was treatment success (seizure termination within 10 minutes and no recurrence 10 minutes to 6 hours after trial drug administration). Secondary efficacy end points were proportion of patients with seizure recurrence 10 minutes to 4 hours, and time-to-next seizure >10 minutes after double-blind drug administration. Safety was monitored throughout.ResultsOf 292 patients administered a test dose, 262 patients were randomized, and 201 received double-blind treatment for an SC (n = 134 MDZ-NS, n = 67 placebo, modified intent-to-treat population). A significantly greater proportion of MDZ-NS- than placebo-treated patients achieved treatment success (53.7% vs 34.4%; P = 0.0109). Significantly, fewer MDZ-NS- than placebo-treated patients experienced seizure recurrence (38.1% vs 59.7%; P = 0.0043). Time-to-next seizure analysis showed early separation (within 30 minutes) between MDZ-NS and placebo that was maintained throughout the 24-hour observation period (21% difference at 24 hours; P = 0.0124). Sixteen patients (5.5%) discontinued because of a treatment-emergent adverse event (TEAE) during the TDP and none during the CP. During the CP, 27.6% and 22.4% of patients in the MDZ-NS and placebo groups, respectively, experienced ≥1 TEAE.SignificanceMDZ-NS was superior to placebo in providing rapid, sustained seizure control when administered to patients experiencing an SC in the outpatient setting and was associated with a favorable safety profile.

Dataset Information

Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded Polytetrafluoroethylene: A Randomized Clinical Trial.

Publications

Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded Polytetrafluoroethylene: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets