Donati 1999.
| Methods | Design: randomised controlled trial. Multi‐centre or single‐centre: single‐centre. Period: not reported. Sample size calculation: not reported. Generation of allocation: not reported. Allocation concealment: not reported. Blinded assessment of treatment allocation: not reported. Withdrawals: not specifically reported but all 60 included. Intention‐to‐treat analysis: not reported. Follow‐up: 21 days | |
| Participants |
How many enter the study on each arm? 60 adults: n = 31 randomly assigned to OKG group (treatment with ornithine α‐ketoglutarate) and n = 29 to placebo/control group (isocaloric, maltodextrins) How many finish the study on each arm? all participants in both groups Mean age: 37 years in treatment group, 39 years in control group Mean total burn surface area (TBSA): 32% Inclusion criteria: 20% to 60% TBSA Exclusion criteria: pulmonary burns; septicaemia; hepatic, renal or cardiac failure; diabetes; pregnancy |
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| Interventions | After shock resuscitation and when digestive capacity had recovered (intestinal sounds present) All participants received NG (n = 23 treated and n = 22 placebo) or oral enteral feed (n = 8 treated and n = 7 placebo) Experimental OKG group (n = 31): received 20 grams ornithine α‐ketoglutarate as 2 boluses of 10 g twice daily Control (n = 29): received isocaloric placebo as 2 × 10 grams maltodextrins |
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| Outcomes | Infection incidence: Local infectious Systemic infectious |
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| Notes | Graft quality and wound healing measures not reliable, no data extracted Other outcomes (biochemical): nitrogenated balance, plasmatic TTR, RBP, graft quality, weight, quality of wound healing |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported: "after blindness removal" mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported. Not clear whether there were exclusions after randomisation |
| Other bias | High risk | Not reported |