J Trauma
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Randomized Controlled Trial Multicenter Study Comparative Study
Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute.
Large wounds often require temporary allograft placement to optimize the wound bed and prevent infection until permanent closure is feasible. We developed and clinically tested a second-generation living human skin substitute (StrataGraft). StrataGraft provides both a dermis and a fully-stratified, biologically-functional epidermis generated from a pathogen-free, long-lived human keratinocyte progenitor cell line, Neonatal Immortalized KeratinocyteS (NIKS). ⋯ The major finding of this phase I/II clinical study is that performance of StrataGraft skin substitute was comparable to cadaver allograft for the temporary management of complex skin defects. StrataGraft skin substitute may also eliminate the risk for disease transmission associated with allograft tissue and offer additional protection to the wound bed through inherent antimicrobial properties. StrataGraft is a pathogen-free human skin substitute that is ideal for the management of severe skin wounds before autografting.
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Randomized Controlled Trial Multicenter Study
HBOC-201 vasoactivity in a phase III clinical trial in orthopedic surgery subjects--extrapolation of potential risk for acute trauma trials.
Vasoactivity has hampered progress of hemoglobin-based oxygen carriers (HBOCs) due to concern for adverse blood pressure responses and secondary complications. A recent formulation, highly polymerized HBOC-201 (Biopure, Cambridge, MA), has been found to be less vasoactive than prior less polymerized formulations, and to improve outcome in animal models of hemorrhagic shock (HS) compared with standard resuscitation fluids. HBOCs are envisioned to have life- saving potential for severe trauma patients for whom death due to HS is common despite transport to level I trauma centers. As part of a benefit:risk analysis for a proposed clinical trial of HBOC-201 in patients with traumatic HS, we analyzed data from a previous phase III clinical trial of this HBOC that involved orthopedic surgery patients, for vasoactivity and related effects, with focus on patients more representative of the trauma population. ⋯ Our limited HEM-0115 safety analysis shows that key potentially vasoactivity-related adverse safety signals were more frequent with HBOC-201 than RBC in older patients undergoing orthopedic surgery with rapid access to safe blood transfusions. That incidences of these safety signals were generally lower and group differences narrowed in subpopulations with stable trauma, hypotension, and younger age, suggests an acceptable safety profile in younger acute trauma populations, especially in settings where rapid access to safe blood transfusions is unavailable; confirmation in controlled clinical trials is urgently warranted.
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Randomized Controlled Trial
Autonomous control of inspired oxygen concentration during mechanical ventilation of the critically injured trauma patient.
Transport of mechanically ventilated patients in a combat zone presents challenges including conservation of resources. In the battlefield setting, the provision of adequate oxygen supplies remains a significant issue. Autonomous control of oxygen concentration may allow a reduction in mission load. ⋯ Autonomous control of FIO2 offers the opportunity for a reduction in oxygen usage, allowing a weight and resource reduction, without increasing risk of hypoxemia in ventilated trauma patients.
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Randomized Controlled Trial Comparative Study
The standardized live patient and mechanical patient models--their roles in trauma teaching.
We have previously demonstrated improved medical student performance using standardized live patient models in the Trauma Evaluation and Management (TEAM) program. The trauma manikin has also been offered as an option for teaching trauma skills in this program. In this study, we compare performance using both models. ⋯ Using the TEAM program, we have demonstrated that improvement in knowledge and skills are equally enhanced by using mechanical or patient models in trauma teaching. However, students overwhelmingly preferred the mechanical model.
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Randomized Controlled Trial
Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study.
The administration of etomidate for rapid sequence induction (RSI) has been linked to subsequent adrenocortical insufficiency in nontrauma patients. However, etomidate-related adrenocortical insufficiency has not been well studied in the trauma population. ⋯ The use of etomidate for RSI in trauma patients led to chemical evidence of adrenocortical insufficiency and may have contributed to increased hospital and ICU lengths of stay and increased ventilator days. Further studies should be considered to evaluate the safety profile of this drug in trauma patients.