Major burn injuries: Thermal related trauma with burn injury involving significant proportions of the total body surface area, as defined by age: Adults (>=17 years old): >= 15% body surface area involved in burns Children (=10% body surface area involved in burns
Conditions
Interventions
Product Name: Synbiotic 2000 Forte
Product Code: Synbiotic 2000 Forte
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: Lactobacillus paracasei ssp paracasei
Concentration type:
Sponsors
South Manchester University Healthcare Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All major burn patients presenting to Manchester Regional Burn Centres: Adults (>= 17 years) with >= 15% TBSA superficial dermal burn injury (or deeper) Children (> 12 months & = 10% TBSA superficial dermal burn injury (or deeper) AND Anticipated to have an inpatient admission in excess of 2 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Injuries that behaving fundamentally differently to thermal burns: Chemical burns Electrical burns Non-burns (e.g. Staphylococcal Scalded Skin Syndrome etc...) Major non-burn trauma in addition to a major burn injury Delayed presentation (>12 hours post-injury) Immunocompromised patients: Severely immunocompromised Post-transplant Altered physiology: Pregnant patients Children 24 consecutive hours of TPN as only source of nutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine if oral or enteral feeding of a synbiotic product twice daily to victims of major thermal trauma reduces the incidence of infections.;Secondary Objective: Assess other potential benefits of synbiotic use in major thermal trauma, including: reductions in the length of hospital & ICU stay, reduction of burn depth progression, reduced healing times, improved scarring, modification of the stress response, reductions in catabolism, improved nutritional outcomes, reduction of the systemic inflammatory response, normalisation of coagulation, reductions in transfusion requirements, improvements in gastrointestinal function, improved availability of trace elements, reduction in electrolyte disturbances, improvements in lipid handling, improved trends in physiological scoring systems. Observe and assess for any side-effects of synbiotic administration.;Primary end point(s): 12 months following patient discharge from hospital OR Patient death | — |
Countries
United Kingdom
Outcome results
None listed