An observational study in Burns, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 1 Year to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Observational
The study aims to validate neutrophil function, immature granulocyte and plasma free DNA levels as predictive diagnostic biomarkers of sepsis in burn patients. Inclusion criteria includes healthy volunteers, patients aged 5-15 years old with burns affecting 20% or less Total Body Surface Area (TBSA) and patients aged 16 or above with burns affecting >15% TBSA. The study involves taking blood, tissue and urine samples.
The initial cohort for SIFTI-2 will be generated from patients attending the Birmingham Burns Centre at Queen Elizabeth Hospital Birmingham (QEHB) and Birmingham Children's Hospital (BCH). The cohort will be comprised of patients with moderate and severe burns (injury to more than 15% of the body surface area [TBSA] in adults and 20% TBSA in children). The investigators currently treat between 30-40 patients in this category each year. In order to thoroughly characterise the longitudinal neutrophil response to burn injury and to investigate its potential relationship with outcome post-burn, the ivestigators will measure the genomic, phenotypic and functional response of peripheral blood neutrophils across time in burn-injured patients.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 245 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects will be admitted to any Burn Centre participating in the study. This includes but not limited to:
Queen Elizabeth Hospital Birmingham; Birmingham Children's Hospital; Mid Essex NHS Trust, Broomfield Hospital, Chelmsford
The patients will be new burns patients presented within 24 hours of thermal injury. They will be identified by the admitting doctor from the Burns Team.
Exclusion Criteria:
with the condition
Other: taking of blood, urine and blood samples and objective scar assessment
without the condition (blood sampling only for adults) and children undergoing general anaesthetic procedures that involve skin resections (blood sampling and excised skin)
blood, urine and skin tissue sampling \& scar assessment questionnaires
Diagnosis of sepsis
Sepsis will be evaluated according to the 2007 American Burn Association (ABA) diagnostic criteria for sepsis in burns. Specifically, sepsis will be diagnosed when 3 of the following criteria are met along with a positive bacterial culture or when evidence of a clinical response to antibiotics is detected: 1. Temperature (\>39°C or \<36°C) 2. progressive tachycardia (\>110 beats per minute 3. progressive tachypnea (\>25 breaths per minute not ventilated or minute ventilation \>12 L/minute ventilated) 4. thrombocytopenia (\<100,000/μl; not applied until 3 days after initial resuscitation) 5. hyperglycaemia (untreated plasma glucose \>200 mg/dl, \>7 units of insulin/hr intravenous drip, or \>25% increase in insulin requirements over 24 hours) 6. feed intolerance \>24 hours (abdominal distension, residuals two times the feeding rate, or diarrhoea \>2500 ml/day)
Time frame: 2 years
In-hospital mortality
Death while in-hospital
Time frame: 2 years
Predictive mortality scores
Predictive mortality scores are measured by Revised Baux Score, Abbreviated Burn Severity Index (ABSI), and APACHE II
Time frame: 2 years
Multiple Organ Failure/dysfunction syndrome (MOF/MODS)
The presence of altered organ function where homeostasis cannot be maintained without intervention using Denver 2 and SOFA scores. For Denver score, MOF is defined as \> 3, two (2) organ system involved for 2 consecutive days while in SOFA, MOF\> = 4 , two (2) organ system involved for first 24 hours. In the subsequent time points, only cardiac scores for SOFA and Denver 2 are recorded.
Time frame: 2 years
Thromboembolic complications
Clinical signs and symptoms associated with thrombosis, i.e., pulmonary embolism, deep vein thrombosis. Clinical investigation to confirm thrombosis will be based on any of the following imaging procedure: CTPA, VQ Scan, USS, Venogram, D-dimer results
Time frame: 2 years
Vancouver Scar Scale (VSS)
This scale uses a numerical assessment of four skin characteristics including: Height (range, 0-4), Pliability (range, 0-4), Vascularity (range, 0-3), and Pigmentation (range, 0-3). The assessors choose a numerical value for each of these characteristics based on a comparison with normal skin.
Time frame: 2 years
Patient and Observer Scar Assessment Scale
Patient and Observer Scar Assessment Scale (POSAS, version 2.0) - The POSAS questionnaire seeks to measure scar quality and is a subjective scar scale that consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale and together they make up the 'Total Score' of the Patient and Observer Scale. The POSAS Patient scale assesses the scar in terms of pain, itching, scar colour, stiffness, thickness and irregularity and overall opinion. The POSAS Observer scale assesses the scar in terms of vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion.
Time frame: 2 years
Brisbane Burn Scar Impact Profile
Brisbane Burn Scar Impact Profile (BBSIP, version 1.0) - This questionnaire assesses the health-related quality of life in people with burn scars. It consists of seven parts which measure; (a) the overall impact of burn scars (itch, pain and other sensations, and their impact on the subject), (b) the impact of the burn scars on work and daily activities, (c) the impact of the burn scars on relationships and social interactions, (d) the subjects perception of the impact of the burn scars on their appearance, (e) the subjects emotional reactions towards their scars and (f) the physical symptoms caused by the burn scars.
Time frame: 2 years
Plan to share: No
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University Hospital Birmingham NHS Foundation Trust