Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.
ABSTRACT: BACKGROUND:Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identify risk factors for PU after SCI, and find an effective and less time-consuming treatment for the condition among different available methods for follow-up. METHOD/DESIGN:The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design. The study will identify possible risk factors for acquiring PU. A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014. In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial (RCT) where we will compare outpatient SCI follow-up in a hospital versus outpatient follow-up from the patient's home, using telemedicine (teleSCI) interventions. We will compare the healing of the PU in the two groups (usual care versus teleSCI). The Tissue, Infection, Moisture Edge (TIME) registration form, the Photographic Wound Assessment Tool (PWAT) and the change in the ulcer size will be used to monitor the healing. Changes in health-related quality of life (HRQoL) and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale (EQ-5D), the generic Medical Outcomes Study 12-item Short Form Health Survey (SF-12) modified version, the International Spinal Cord Injury Quality of Life Data set (ISCI-QoL Data set), and the Spinal Cord Independence Measure scale, version III (SCIM III). In addition to primary outcome measures, a cost-benefit evaluation and an assessment of patient satisfaction and participation will be performed, using customized questionnaires. DISCUSSION:The first part of the research project will reveal the epidemiology of PU after SCI, and explore the risk factors. This part enables further prevention of PU after SCI and this information will be used in the follow-up RCT. Videoconferencing in the outpatient follow-up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration, communication and competence exchange among participants of the health care services. Our research protocol allows comparing methods for interaction between medical specialists at hospitals, local caregivers in the community, next of kin, and persons with SCI and PU. The RCT should identify advantages as well as challenges in the management of PU in different follow-up settings. This study aims to identify risk factors for PU after SCI, and find an effective and less time consuming treatment for the condition among different available methods for follow- up. TRIAL REGISTRATION:1. www.ClinicalTrials.gov , ID: NCT02800915 , last update 9 October 2017. 2. The National Regional Ethical Committee (REC) 2014/ 684/ REK-Nord. https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=469163&p_parent_id=473640&_ikbLanguageCode=n 3. https://app.cristin.no/projects/show.jsf?id=545284 4. https://www.sunnaas.no/kliniske-studier/bruk-av-telemedisin-som-virkemiddel-til-samhandling-i-poliklinisk-oppfolging-av-pasienter-med-ryggmargsskade-og-trykksar.
Project description:Objective: Severe pressure ulcers (PUs) do not respond to conservative wound therapy and need surgical repair. To better understand the pathogenesis and to advance on new therapeutic options, we focused on the proteomic analysis of PU, which offers substantial opportunities to identify significant changes in protein abundance during the course of PU formation in an unbiased manner. Approach: To better define the protein pattern of this pathology, we performed a proteomic approach in which we compare severe PU tissue from spinal cord injury (SCI) patients with control tissue from the same patients. Results: We found 76 proteins with difference in abundance. Of these, 10 proteins were verified as proteins that define the pathology: antithrombin-III, alpha-1-antitrypsin, kininogen-1, alpha-2-macroglobulin, fibronectin, apolipoprotein A-I, collagen alpha-1 (XII) chain, haptoglobin, apolipoprotein B-100, and complement factor B. Innovation: This is the first study to analyze differential abundance protein of PU tissue from SCI patients using high-throughput protein identification and quantification by tandem mass tags followed by liquid chromatography tandem mass spectrometry. Conclusion: Differential abundance proteins are mainly involved in tissue regeneration. These proteins might be considered as future therapeutic options to enhance the physiological response and permit cellular repair of damaged tissue.
Project description:The advancements in material science and technology have made polyurethane (PU) one of the most important renewable polymers. Enhancing the physio-chemical and mechanical properties of PU has become the theme of this and many other studies. One of these enhancements was carried out by adding starch to PU to form new renewable materials called polyurethane-starch composites (PUS). In this study, PUS composites are prepared by adding starch at 0.5, 1.0, 1.5, and 2.0 wt.% to a PU matrix. The mechanical, thermal, and morphological properties of PU and PUS composites were investigated. Scanning electron microscope (SEM) images of PU and PUS fractured surfaces show cracks and agglomeration in PUS at 1.5 wt.% starch. The thermo-mechanical properties of the PUS composites were improved as starch content increased to 1.5 wt.% and declined by more starch loading. Despite this reduction, the mechanical properties were still better than that of neat PU. The mechanical strength increased as starch content increased to 1.5 wt.%. The tensile, flexural, and impact strengths of the PUS composites were found to be 9.62 MPa, 126.04 MPa, and 12.87 × 10-3 J/mm², respectively, at 1.5 wt.% starch. Thermal studies showed that the thermal stability and crystallization temperature of the PUS composites increased compared to that of PU. The loss modulus curves showed that neat PU crystallizes at 124 °C and at 127 °C for PUS-0.5 wt.% and rises with increasing loading from 0.5 to 2 wt.%.
Project description:<h4>Background</h4>Pressure ulcers (PUs) are complications of serious acute/chronic illness. Specialist mattresses used for prevention lack high quality effectiveness evidence. We aimed to compare clinical and cost effectiveness of 2 mattress types.<h4>Methods</h4>Multicentre, Phase III, open, prospective, parallel group, randomised controlled trial in 42 UK secondary/community in-patient facilities.2029 high risk (acutely ill, bedfast/chairfast and/or Category 1 PU/pain at PU site) adult in-patients were randomised (1:1, allocation concealment, minimisation with random element) factors including: centre, PU status, facility and consent type. Interventions were alternating pressure mattresses (APMs) or high specification foam (HSF) for maximum treatment phase 60?days. Primary outcome was time to development of new PU Category ? 2 from randomisation to 30?day post-treatment follow-up in intention-to treat population. Trial registration: ISRCTN 01151335.<h4>Findings</h4>Between August 2013 and November 2016, we randomised 2029 patients (1016 APMs: 1013 HSF) who developed 160(7.9%) PUs. There was insufficient evidence of a difference between groups for time to new PU Category ? 2 Fine and Gray Model Hazard Ratio HR?=?0.76, 95%CI0.56-1.04); exact P?=?0.0890; absolute difference 2%). There was a statistically significant difference in the <i>treatment phase time to event sensitivity analysis</i>, Fine and Gray model HR?=?0.66, 95%CI, 0.46-0.93; exact P?=?0.0176); 2.6% absolute difference). Economic analyses indicate that APM are cost-effective.There were no safety concerns.<h4>Interpretation</h4>In high risk (acutely ill, bedfast/chairfast/Category 1 PU/ pain on a PU site) in-patients, we found insufficient evidence of a difference in time to PU development at 30-day final follow-up, which may be related to a low event rate affecting trial power. APMs conferred a small treatment phase benefit. Patient preference, low PU incidence and small group differences suggests the need for improved targeting of APMs with decision making informed by patient preference/comfort/rehabilitation needs and the presence of potentially modifiable risk factors such as being completely immobile, nutritional deficits, lacking capacity and/or altered skin/Category1 PU.
Project description:OBJECTIVE:To evaluate the effects of pressure threshold respiratory training (RT) on heart rate variability and baroreflex sensitivity in persons with chronic spinal cord injury (SCI). DESIGN:Before-after intervention case-controlled clinical study. SETTING:SCI research center and outpatient rehabilitation unit. PARTICIPANTS:Participants (N=44) consisted of persons with chronic SCI ranging from C2 to T11 who participated in RT (n=24), and untrained control subjects with chronic SCI ranging from C2 to T9 (n=20). INTERVENTIONS:A total of 21±2 RT sessions performed 5 days a week during a 4-week period using a combination of pressure threshold inspiratory and expiratory devices. MAIN OUTCOME MEASURES:Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and beat-to-beat arterial blood pressure and heart rate changes during the 5-second-long maximum expiratory pressure maneuver (5s MEP) and the sit-up orthostatic stress test, acquired before and after the RT program. RESULTS:In contrast to the untrained controls, individuals in the RT group experienced significantly increased FVC and FEV1 (both P<.01) in association with improved quality of sleep, cough, and speech. Sympathetically (phase II) and parasympathetically (phase IV) mediated baroreflex sensitivity both significantly (P<.05) increased during the 5s MEP. During the orthostatic stress test, improved autonomic control over heart rate was associated with significantly increased sympathetic and parasympathetic modulation (low- and high-frequency change: P<.01 and P<.05, respectively). CONCLUSIONS:Inspiratory-expiratory pressure threshold RT is a promising technique to positively affect both respiratory and cardiovascular dysregulation observed in persons with chronic SCI.
Project description:Riluzole is a sodium channel-blocking agent used in treating amyotrophic lateral sclerosis. It has been approved by the U.S. Food and Drug Administration, Canadian and Australian authorities, and in many other countries. A phase I trial of riluzole for acute spinal cord injury (SCI) provided safety and pharmacokinetic data and suggested neuroprotective benefits. A phase IIB/III double-blinded randomized controlled trial (RCT) started in January 2014 (https://clinicaltrials.gov, NCT01597518). This article describes the pathophysiological rationale, preclinical experience and design of the phase IIB/III RCT of Riluzole in Acute Spinal Cord Injury Study (RISCIS).The primary objective of the trial is to evaluate the superiority of riluzole, at a dose of 100?mg BID in the first 24?h followed by 50?mg BID for the following 13 days post injury, compared with placebo in improving neurological motor outcomes in patients with C4-C8 level, International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) grade A, B or C acute (within 12?h post injury) SCI.Acute trauma centers worldwideMethods:A double-blind, multi-center, placebo-controlled RCT will enroll 351 participants randomized 1:1 to riluzole and placebo. The primary end point is the change between 180 days and baseline in ISNCSCI Motor Score. This study has 90% power to detect a change of nine points in ISNCSCI Motor Score at one-sided ?=0.025.Currently enrolling in 11 centers.This study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI.
Project description:For the fabrication of a peelable coating material that decomposes methyl paraoxone (MPO), a nerve agent simulant, self-crosslinkable waterborne polyurethanes (PUs) containing silane groups at the ends and a metal organic framework (UiO-66) were synthesized. UiO-66 dispersed PU solutions for spray coating were prepared by controlling the amount of silane in PU and the content of UiO-66. PUs with a large amount of silane (more than 7.2 wt.%) were easily gelated by adding UiO-66 because the solution was changed from neutral (pH = 7.3) to strongly acidic (pH = 2.5). Therefore, the silane content in PUs should be carefully controlled for the fabrication of composite films. When UiO-66 was added to the PU with a silane content of 2.7 wt.%, the reinforcing effect by UiO-66 was observed up to 15.3 wt.%, but a further increase in UiO-66 content decreased both the tensile strength and the elongation. The peel strength of the PU composite films on polyethylene (PET) and glass substrates decreased with increasing UiO-66 content, but their MPO conversion increased with increasing UiO-66 content. The PU composite film with 49.5 wt.% of added UiO-66 showed the MPO conversion of 63.2% and was easily peeled off from PET and glass substrates.
Project description:Study design:A cross-sectional multi-center study using an on-line survey addressing utilization, knowledge, and perceptions of medicinal cannabis (MC) by people with spinal cord injury (SCI). Objective:To characterize differences between current (CU), past (PU), and never users (NU) of MC with SCI; to determine why people with SCI use MC; to examine reports of MCs' efficacy and tolerability by individuals with SCI. Setting:Three academic medical centers in the United States. Methods:Comparison of demographic and attitudinal differences between CU, PU, and NU and differences in the groups' reports of pain, health, and quality of life (QOL). Evaluation of utilization patterns and perceived efficacy of MC among CU and PU and reports of side effects of MC versus prescription medications. Data were analyzed using either Chi Square, distribution-free exact statistics, or t-tests for continuous data. Results:Among a nationwide sample (n?=?353) of individuals with SCI, NU were less likely than CU and PU to believe that cannabis ought to be legalized and more likely to endorse risks of use. Current users and PU reported greater pain interference in daily life than did NU, but there were no between group differences in QOL or physical or emotional health. Current users and PU took MC to address pain (65.30%), spasms (63.30%), sleeplessness (32.70%), and anxiety (24.00%), and 63.30% reported it offered "great relief" from symptoms. Participants reported that MC is more effective and carries fewer side effects than prescription medications. Conclusions:Medicinal cannabis is an effective and well-tolerated treatment for a number of SCI-related symptoms.
Project description:People with spinal cord injury (SCI) are predisposed to pressure ulcers (PU). PU remain a significant burden in cost of care and quality of life despite improved mechanistic understanding and advanced interventions. An agent-based model (ABM) of ischemia/reperfusion-induced inflammation and PU (the PUABM) was created, calibrated to serial images of post-SCI PU, and used to investigate potential treatments in silico. Tissue-level features of the PUABM recapitulated visual patterns of ulcer formation in individuals with SCI. These morphological features, along with simulated cell counts and mediator concentrations, suggested that the influence of inflammatory dynamics caused simulations to be committed to "better" vs. "worse" outcomes by 4 days of simulated time and prior to ulcer formation. Sensitivity analysis of model parameters suggested that increasing oxygen availability would reduce PU incidence. Using the PUABM, in silico trials of anti-inflammatory treatments such as corticosteroids and a neutralizing antibody targeted at Damage-Associated Molecular Pattern molecules (DAMPs) suggested that, at best, early application at a sufficiently high dose could attenuate local inflammation and reduce pressure-associated tissue damage, but could not reduce PU incidence. The PUABM thus shows promise as an adjunct for mechanistic understanding, diagnosis, and design of therapies in the setting of PU.
Project description:Pressure ulcers (PU) are known to be a high-cost disease with a risk of severe morbidity. This paper evaluates a new clinical strategy based on an innovative medical device [Tongue Display Unit (TDU)] that implements perceptive supplementation in order to reduce prolonged excessive pressure, recognized as one of the main causes of PU. A randomized, controlled, and parallel-group trial was carried out with 12 subjects with spinal cord injuries (SCI). Subjects were assigned to the control (without TDU, [Formula: see text]) or intervention (with TDU, [Formula: see text]) group. Each subject took part in two sessions, during which the subject, seated on a pressure map sensor, watched a movie for one hour. The TDU was activated during the second session of the intervention group. Intention-to-treat analysis showed that the improvement in adequate weight shifting between the two sessions was higher in the intervention group (0.84 [0.24; 0.89]) than in the control group (0.01 [-0.01; 0.09]; [Formula: see text]) and that the ratio of prolonged excessive pressure between the two sessions was lower in the intervention group (0.74 [0.37; 1.92]) than in the control group (1.72 [1.32; 2.56]; [Formula: see text]). The pressure map sensor was evaluated as being convenient for use in daily life; however, this was not the case for the TDU. This paper shows that persons with SCI could benefit from a system based on perceptive supplementation that alerts and guides the user on how to adapt their posture in order to reduce prolonged excessive pressure, one of the main causes of PU.
Project description:The present article reports the investigation on the effects of solvent and position of functionality on various physical properties of polyurethanes (PUs) based on hydroxyl-terminated polybutadiene (HTPB). The PU films (curative) were prepared by coupling HTPB (P0) with isophorone diisocyanate (IPDI) in various solvent media. The PUs obtained in different solvent media displayed similar thermal profile and glass transition temperature (T g), but their tensile properties varied significantly. Optimized tensile properties were observed when tetrahydrofuran was used as the solvent media. In the course, the investigation of the functionality effect, tetrazole (M1, M2, and M3) were covalently attached at the terminal carbon of HTPB to obtain three modified HTPBs (P1, P2, and P3), thereby coupling with IPDI to obtain the corresponding tetrazole functional PUs films. Pristine (P0-PU) and functional PU (P1-PU, P2-PU, and P3-PU) films have similar thermal profile and T g (-76 °C), but they have a notable enhancement in tensile properties; for example, tensile strength and elongation at break of P0-PU were found to be 3.21 MPa and 727%, respectively, whereas these values were 4.84 MPa and 958%, respectively, in the case of P3-PU. It was observed that on increasing the number of methylene group from 1 to 3 between HTPB and tetrazole moiety, the strength of hydrogen bonding increases, which facilitates better packing of urethane network in the PU and hence improves the tensile properties. Also, modification of pristine HTPB with tetrazole derivatives enhanced the calorific values of the resulting PUs.