Barriers to clinical research in trauma

Miskimins, Richard; Pati, Shibani; Schreiber, Martin A.

doi:10.1111/trf.15097

Cited by 20 publications

(15 citation statements)

References 51 publications

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“…For example, can a patient with traumatic compound bone fractures be afforded enough time and harbor the mental faculties to make a fully informed decision regarding the use of a novel biomaterial fixation device (Stevens, 2008)? As this example illustrates, severely injured trauma patients can seldom provide appropriate informed consent for clinical research, hindering the effectiveness of novel biomaterial development designed for trauma cases (Dutton et al, 2008;Miskimins et al, 2019). However, the FDA does provide narrow guidelines for exceptions to informed consent in emergency research under 21 CFR50.24 (Biros, 2003).…”

Section: Ethical Considerations In Preclinical Animal Researchmentioning

confidence: 99%

Navigating ethical challenges in the development and translation of biomaterials research

Hunckler

Levine²

2022

Front. Bioeng. Biotechnol.

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Biomaterials--from implanted iron teeth in the second century to intraocular lenses, artificial joints, and stents today--have long been used clinically. Today, biomaterials researchers and biomedical engineers are pushing beyond these inert synthetic alternatives and incorporating complex multifunctional materials to control biological interactions and direct physiological processes. These advances are leading to novel strategies for targeted drug delivery, drug screening, diagnostics and imaging, gene therapy, tissue regeneration, and cell transplantation. While the field has survived ethical transgressions in the past, the rapidly expanding scope of biomaterials science, combined with the accelerating clinical translation of this diverse field calls for urgent attention to the complex and challenging ethical dilemmas these advances pose. This perspective responds to this call, examining the intersection of research ethics -- the sets of rules, principles and norms guiding responsible scientific inquiry -- and ongoing advances in biomaterials. While acknowledging the inherent tensions between certain ethical norms and the pressures of the modern scientific and engineering enterprise, we argue that the biomaterials community needs to proactively address ethical issues in the field by, for example, updating or adding specificity to codes of ethics, modifying training programs to highlight the importance of ethical research practices, and partnering with funding agencies and journals to adopt policies prioritizing the ethical conduct of biomaterials research. Together these actions can strengthen and support biomaterials as its advances are increasingly commercialized and impacting the health care system.

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Section: Ethical Considerations In Preclinical Animal Researchmentioning

confidence: 99%

Navigating ethical challenges in the development and translation of biomaterials research

Hunckler

Levine²

2022

Front. Bioeng. Biotechnol.

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“…Very few studies include these patients because follow-up data of these patients are often unavailable. This selective follow-up is a challenge in geriatric trauma research but can be addressed by searching death registries or telephone follow-up [18]. The authors of this study recommend that these patients are included in future investigations, to get a more accurate representation of the ED population.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Predictors of 30-day mortality in orthogeriatric fracture patients aged 85 years or above admitted from the emergency department

Schuijt

Bos

Smeeing

et al. 2019

Eur J Trauma Emerg Surg

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Purpose Orthogeriatric trauma patients are at risk for functional decline and mortality. It is important to identify high-risk patients in an early stage, to improve outcomes and make better informed treatment decisions. The aim of this study was to identify independent risk factors for 30-day mortality in patients aged 85 years or above admitted from the emergency department with a fracture. Methods All orthopaedic trauma patients 85 years or above admitted from the emergency department were included. After a 30-day follow-up, mortality was determined by consulting the patient records. Multivariable logistics regression analysis generated odd ratios for mortality risk factors. A subgroup analysis was performed for patients undergoing hip fracture surgery. Results The 30-day mortality in geriatric fracture patients admitted to the hospital was 12%. Risk factors for 30-day mortality were: increased age, male sex, decreased hemoglobin levels, living in an institutional care facility and a decreased BMI. For geriatric patients undergoing hip fracture surgery 30-day mortality was 11%. Independent risk factors for this group were: increased age, male sex, and a decreased BMI. Conclusion Orthopaedic trauma patients aged 85 years or above who are admitted to the hospital with a fracture are at high risk for mortality. This study identified older age, male sex, and decreased BMI as predictors of 30-day mortality in admitted geriatric fracture patients and in geriatric hip fracture patients undergoing surgery.

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“…In addition, the patient undergoes two or more separate surgical interventions necessary for the extraction and implantation of autologous material. Moreover, in a number of countries, the administration of cultured cells is strictly regulated by biomedical laws that require registration of a cell product before clinical use [13][14][15] . Isolation of autologous BM-MNCs and seeding of the bone autograft with cells directly in the O.R.…”

Section: Introductionmentioning

confidence: 99%

Minimally Manipulated Bone Marrow-Derived Cells Can Be Used for Tissue Engineering In Situ and Simultaneous Formation of Personalized Tissue Models

Baranovskii

Demchenko

et al. 2022

Bull Exp Biol Med

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Background: The use of tissue-engineered bone autografts is a promising approach for bone defects restoration. The isolation of cells and their seeding on bone autograft is usually carried out in a laboratory, requiring significant time and two separate surgical interventions. Intraoperative creation of tissueengineered bone autograft can represent a perspective solution. The aim of this study is to investigate the possibility of creation of tissue-engineered bone autograft by intraoperative enrichment of bone tissue with bone marrow-derived mononuclear cells (BM-MNCs) isolated simultaneously. Methods. Red bone marrow and autologous bone tissue (bone fragments and bone chips) of the donor were harvested intraoperatively. BM-MNCs were isolated, and bone fragments were enriched with BM-MNCs intraoperatively. Assessment of the adhesion and proliferation of BM-MNCs on bone fragments was carried out by fluorescence microscopy and histological examination. MTT assay was used to compare metabolic activity of BM-MNCs and wBMA cells seeded on bone chips. Results. Autologous bone fragments were colonized with autologous BM-MNCs isolated simultaneously in the O.R. with further adhesion and active growth of cells. When seeded on bone chips, metabolic activity of BM-MNCs was statistically significantly higher compared to wBMA cells (p-value=0.0272) on day 14. There was no difference in metabolic activity of BM-MNCs and wBMA cells cultured in nutrient medium without bone chips. Conclusion. Technically simple method of intraoperative enrichment of autologous bone fragments with BM-MNCs isolated simultaneously allowed to create tissue-engineered bone autograft in the O.R. The safety and effectiveness of intraoperatively enriched autografts should be investigated further.

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Barriers to clinical research in trauma

Cited by 20 publications

References 51 publications

Navigating ethical challenges in the development and translation of biomaterials research

Navigating ethical challenges in the development and translation of biomaterials research

Predictors of 30-day mortality in orthogeriatric fracture patients aged 85 years or above admitted from the emergency department

Minimally Manipulated Bone Marrow-Derived Cells Can Be Used for Tissue Engineering In Situ and Simultaneous Formation of Personalized Tissue Models

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