Current Clinical Studies
In addition to basic science projects, The Burn Center also has a flourishing Clinical Research department.
AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections
Necrotizing soft tissue infections (NSTI) represent the most severe types of infections involving the skin, skin structures and soft tissue. This Phase 3 trial, also known as the ACCUTE trial, is designed as a single pivotal study to assess the efficacy and safety of AB103 versus placebo in patients with NSTI. The study is planned to recruit 290 patients, utilizing a 1:1 randomization schema, from approximately 40 investigative sites in the US. It will be evaluating the clinical composite endpoint that includes elements of both the local and systemic manifestations of NSTI.
The RE-ENERGIZE Study
Enteral glutamine has been found to decrease mortality in critically ill patients and blood infection in trauma patients. A pilot study found the same protective effect of glutamine against blood infection in severely burned adult patients. In addition, a significant decrease in mortality was observed with glutamine. This pilot study will examine the difference in clinical outcomes including mortality, incidence of infectious episodes, clinical status during the ICU stay and length of care in adult with severe burns for enteral glutamine compared to a placebo. The study is a multi-center, prospective, double blinded, and controlled randomized clinical trial.
Cold injuries can be classified as nonfreezing tissue injury, frostbite, and hypothermia. Frostbite represents a spectrum of injury extending from reversible changes to irreversible tissue destruction as a result of direct cellular damage at the time of cold exposure and secondarily progressive dermal ischemia. These injuries are often difficult to treat due to discrepancies in the extent of damage. While frostbite is less frequently treated in burn centers, it poses many of the same challenges present in thermal burn injuries. This is mostly due to the similarities in the process of progressive ischemic damage seen in both injuries. Characterizing these injuries and identifying risk factors which correlate with worse outcomes is essential in determining the best care for these patients.
While the etiologies contributing to burn graft loss are well studied, there exists no consensus definition of burn graft loss, nor a scale with which to grade severity and track as a quality improvement metric. As a consequence, the current overall failure rate of skin grafts for burn injuries is not known. This hinders research aimed to elucidate factors contributing to graft loss as well as associated morbidities. The aim of this retrospective study is to better define the risk factors associated with graft loss and the impact on clinical outcomes in our patient population.
Evaluating Nutritional Supplementation
Appropriate nutritional support is a pivotal component of burn patient care. Significant elevations in metabolic rate are known to occur following burn injury, and addressing caloric needs in the setting of acute critical illness represents an important challenge for clinicians. Various formulas for calculating the energy requirements of patients have been proposed, but all have had various shortfalls in the setting of burn injury. To address these shortfalls, burn dietitians at our institution began using a combination of existing formulas several years ago to provide initial targets for caloric and protein goals. The aim of this retrospective study is to evaluate the utility of the MWHC modified formula, using the patient’s measured UUNs to assess the nutritional balance of these patients receiving enteral or parenteral nutrition while hospitalized. These observations will subsequently aid in optimization of current dietary protocols, and potentially identify additional clinical parameters that can be utilized as reliable markers of inadequate nutritional support in inpatients.
BARDA Burn Study
Funded by the Biomedical Advanced Research and Development Authority (BARDA), The Firefighters’ Burn and Surgical Laboratory is taking part in a multi-center trial that examines autologous platelet rich plasma (PRP) from whole blood as a therapy to promote hemostasis, re-epithelialization, healing, regeneration, and reduce the risk of infection in patients with burn injury.
Many investigators within MedStar Health Research Institute have a need for “banked” tissue. Currently, individual investigators within their own laboratories assume the responsibility for the care and maintenance of small “project focused” repositories. In order to eliminate redundancy, facilitate inter-/intra-laboratory collaboration and foster larger cross-discipline studies, a core facility has been established at the Firefighters' Burn and Surgical Research Lab (FBSRL).
The establishment of a biospecimen repository in the FBSRL allows for the storage of specimens and the ability to process such specimens according to protocol-mandated specifications. This dynamic resource is equipped with the most up-to-date specimen tracking system and sample preparation equipment. The location of the laboratory on the campus of the MedStar Washington Hospital Center makes clinical sample acquisition and transport easy and straightforward.
The Burn Center was recently awarded a grant by the Army Research Office to study gross and occult markers of coagulopathy in thermally-injured patients. This grant will provide funding for a 3 year pilot study focused on elucidating early changes in coagulopathy, and studying how those changes effect the clinical course of burn patients. This study will utilize a systems biology approach to uncover minute coagulopathic changes that might otherwise go unnoticed until it is too late.
DoD Burn Study
Funded by the Department of Defense (DoD), The Firefighters’ Burn and Surgical Laboratory is taking part in a multi-center trial that examines autologous platelet rich plasma (PRP) from whole blood as a therapy to promote hemostasis, re-epithelialization, healing, regeneration, and reduce the risk of infection in patients with burn injury.
Partnering with the Plastic and General Surgeons at MedStar Washington Hospital Center, the Firefighters’ Burn and Surgical Research Laboratory will be collecting large ellipses of skin and subcutaneous tissue resected from affected groins, axillae, and/or gluteal folds from the operating room. Over time, a repository of specimens will be built from multiple anatomical locations, various racial and gender backgrounds, as well as an array of ages to investigate whether these factors influence the symptoms of hidradenitis suppurativa.
Cell Separation Spray Applicator
As part of a multi-center clinical research study funded by the Department of Defense and US Army (AFIRM), The Firefighters’ Burn and Surgical Laboratory is helping to test the efficacy of a cell separation device containing enzymatic and carrier solutions, sterile surgical instruments, and spray applicators for the purpose of harvesting epidermal cells for epidermal repair. The harvested cells include keratinocytes, melanocytes, and fibroblasts that will hopefully help to minimize the risk of hypertrophic scar and color mismatch within the healed wound site.
High-Volume Hemofiltration for Acute Renal Failure
The Firefighters’ Burn and Surgical Laboratory is one of nine sites to be selected to participate in an interventional multi-center trial that is funded by the American Burn Association. The trial looks to enroll patients with acute renal failure secondary to septic shock, in which patients may receive high-volume hemofiltration in addition to contemporary care. Outcomes look to determine improvements in clinical values in the intervention arm.
Previous Clinical Studies
Comparison of Metabolic Needs Between Obese and Non-Obese Theramlly Injured Patients
The Effects of Prolonged Pressure on Blood Flow in the Face
Hepatic insufficiency on morality following thermal injury
International Nutrition Survey
Nutritional Support Survey of Obese Burn Patients
LDI Imaging of Facial Cutaneous Blood Flow through Clear Pressure Masks
Potential role of melatonin in burn shock
Retinol A for use of skin regeneration in burn patients
Sepsis and Blood Product Transfusion
Serum levels in burn patients (melatonin, superantigens, and (1,3)-B-D-glucan)
Several Dressing comparison studies
Several pharmaceutical studies as it relates to pain and healing
Several studies involving the effectiveness of pharmaceuticals for Reducing the Pathogenicity of MRSA
Sulfamylon for 5% Topical Solution on Autograft Healing
Thermally Induced Markers of Apoptosis
Vitamin C Infusion in Resuscitation Fluid Requirements
Reconstructive Burn Surgery; Platelet disorders; Red Blood Cell disorders; White Blood Cell disorders; MRSA; Superantigens; Burn Shock; Sepsis; Renal Failure; LDI; Burn Dressing; Thermal Injury; Electrical Injury; Melatonin; Vitamin C; Factors; Cytokines; Antibiotics; Coagulopathy; Neuropathic pain; Hemostasis; Re-epithelialization; Tissue regeneration; Light Therapy; Scarring; Blood Draws; Burn Infection.
The Burn Center at Washington Hospital Center is the adult regional burn care facility for the District of Columbia, Northern Virginia, and Southern Maryland. The Burn Center is recognized by the American Burn Association/American College of Surgeons as a verified burn center. The facility includes a 10 bed self-contained surgical/burn intensive care unit and operating suite; a 20 bed intermediate care unit for continuing wound care and progressive rehabilitation; a nationally respected burn rehabilitation staff for inpatients and outpatient treatment; complete plastic and reconstructive surgery services; and an outpatient burn clinic for follow-up and small burn care. The Burn Center responds to approximately 800 emergency room calls per year, and treats approximately 500 burn inpatients per year.