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Identification of Patients
Because the degree of injury can be reliably estimated from burn size, to define the responses to injury we are enrolling subjects with greater than 20% total body surface area (TBSA) burns into the program. Subjects are further divided into moderate (20%-40% TBSA), severe (40%-60% TBSA), and most severe (>60% TBSA) burns by age groups (0-18, 18+ to 55, and over 55) based on documented increases in mortality with increasing burn size and age.
Protocols for Standard Patient Care
The extent of initial resuscitation efforts and the subsequent care of a burn injured patient have a significant impact on whether the patient recovers or experiences complications, including the development of MOFS and death. Such variability in clinical care would also be expected to impact proteomic and genomic expression patterns. To obviate these concerns, the Burn Research Group has developed standardized protocols for patient care. These evidence- and principle-based SOPs were formulated based on management principles derived from published clinical and laboratory studies, including the American Burn Association as well as current medical and surgical practices for the management of acute burn injury. As implemented, they are considered the standard of care for patient management and are mandated for all enrolled patients as well as for uniform routine care at each of the participating burn centers.
The Journal of Burn Care & Research has published the SOPs in a journal article in its March/April 2007 issue. This article details the rationale and reviews the available clinical data that the burn research group used to construct the SOPs for our burn clinical study. SOPs are described for the management of:
Participating Medical Centers
To ensure standardized care and uniformity of clinical application to all enrolled injured patients, the burn research group selected participating centers that have a long-standing interest and research background in the clinical care of severely burned patients. Centers were selected based both on their research background and also on the volume of patients visiting the center.
The burn centers include the University of Texas Medical Branch (Shriners Hospital for Children in Galveston and Blocker Burn Unit), the University of Washington in Seattle (Harborview Medical Center), the University of Texas Health Science Center in Dallas (Parkland Hospital), and Loyola University in Chicago
(Loyola University Hospital).
A data abstraction tool and system has been developed by the Information Dissemination and Data Coordination (IDDC) core. This database tool houses coded data on severely injured patients, further defines the potential identifiers of risk for MOFS and death, confirms the use of standardized processes of care, and documents pertinent clinical endpoints such as MOFS and death.
The tool also captures resource consumption, such as total length of stay and ICU length of stay. Trial/DB, a non-proprietary Web-based platform developed by Yale University, has been used for the development of clinical data capture to ensure conformity, user friendliness, and consistency across multiple institutions for the enrollment of patient data.
To date, program researchers have generated SOPs for clinical care involving resuscitation of the burn patient as well as the diagnosis and management of a number of critical factors in the management of burn patients. The burn research group has also developed standardized diagnostic criteria for complications. Doing so ensures consistent reporting and quality assessment of treatment and outcomes among the participating trauma centers.