Grippaudo 2010.
Methods | Single centre, parallel, RCT | |
Participants | 80 patients (male 31; female 49) aged between 2 and 65 years with second degree burns to TBSA < 10%. | |
Interventions | Topical application of ionic hydrogel (Procutase) versus application of silver sulphadiazine (SSD) 1% cream on emergency department presentation | |
Outcomes | Time to wound healing Wound infection Pain Adverse effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "..computer random number generator..." Comment: done |
Allocation concealment (selection bias) | Unclear risk | "Once the patient was found to meet enrolment criteria (...) he or she was assigned to one arm or the other of the treatment tree". Inadequate information provided to ascertain whether allocation was concealed |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants would have been aware of treatment group assignment as interventions differed Treating study personnel would have been aware of treatment group assignment as interventions differed Outcome assessor was "unaware which treatment arm was assigned to the subject, and evaluated the wound after the removal of dressing and its cleaning with saline by the nurse" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available for assessment Key outcome data identified in study methods section disclosed Data on adverse events were not completely reported. |
Other bias | Low risk | None detected |