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Comparative methods and endpoints of the two supplementation studies |
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| Study 1 [15] |
Study 2 [16] |
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| Methods |
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| Study design |
Prospective, randomised, placebo-controlled trial |
Prospective, randomised, placebo-controlled trial |
| Stratification |
None |
Age (≥ or <50 years) Inhalation (yes/no) Burned BSA (≥ or <50%) |
| Inclusion and exclusion criteria |
Identical |
Identical |
| Trace elements per day (intravenous) |
Copper 40.4 μmol (2.5 mg)/day Selenium 2.9 μmol (315 μg)/day Zinc 407 μmol (26.2 mg)/day |
Copper 47.6 μmol (3.1 mg)/day Selenium 4.8 μmol (380 μg)/day Zinc 574 μmol (31.4 mg)/day |
| Duration of supplementation |
8 days |
14 days if burns <60% of BSA 21 days if burns ≥60% of BSA |
| Nutritional management |
Early enteral feeding (within 12 hours of admission) targeted at 1.3 times of resting energy expenditure, reached during a period of 4 days |
Identical |
| Vitamins per day |
Vitamin C 1 g, vitamin E 100 mg, vitamin B 100 mg, and multivitamin (Cernevit®; Baxter, Plessis, France) |
Identical |
| Blood sampling |
Days 0, 1, 5, 10, 15, 20, and 30 for plasma trace elements + vitamin dosages |
Identical + plasma GSHPx activity |
| Skin biopsies |
None |
Days 3, 10, and 20: tissue selenium, zinc, and GSHPx activity |
| Endpoints |
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| Clinical endpoints |
Length of mechanical ventilation Length of ICU stay Length of ICU stay per burned percentage of BSA |
Identical |
| Wound healing |
Success of skin grafting (percentage of grafted area per percentage of area with surgical burns) |
Identical + Whole body turnover of glycerol, glucose, and phenylalanine Phenylalanine skin incorporation |
| Immune response |
Chemotaxis capacity of neutrophil T lymphocyte and neutrophil counts Cell surface markers on lymphocytes Adhesion molecules on neutrophils |
Not performed |
| Infectious complications and definition |
Prospective surveillance during the first 30 days of stay according to predefined criteria [18] |
Identical |
| Antibiotic treatment |
Details on antibiotic delivery (type, dose, and route) |
Identical |
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BSA, body surface area; GSHPx, glutathione peroxidase; ICU, intensive care unit. | ||
Berger et al. Critical Care 2006 10:R153 doi:10.1186/cc5084 |
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