Ali 2015.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 73 Inclusion criteria: > 18 years of age; burns wounds ≥ 30% TBSA; treatment with at least 1 surgical skin grafting procedure; consent to participate Exclusion criteria: not reported Type of surgery: skin graft surgery (burns) Baseline characteristics Intervention group (propranolol)
Control group (standard care)
Country: USA Setting: single centre; hospital (burns unit) |
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Interventions |
Intervention group (propranolol)
Control group (standard care)
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Outcomes |
Outcomes measured/reported by study authors: mean dose requirement, cardiac function (HR, tachycardia), wound healing, blood loss, fluid balance, bradycardia (HR < 60 bpm), bradypnea, hypotension (SBP < 90 mmHg), ischaemia (MAP < 60 mmHg), mortality, length of stay (does not state whether hospital or burns unit length of stay) Outcomes relevant to the review: bradycardia, hypotension, mortality (time point not reported) |
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Notes |
Funding/declarations of interest: supported by grants from: Wound Healing Society Foundation 3M Fellowship Award; National Institute for Disabilities and Rehabilitation Research, National Institutes of Health, Shriners Hospitals for Children; Claude D Perpper Older Americans Independence Center Pilot. Funders had no role in the study design or collection, interpretation or analysis of data. Study authors declared no conflicts of interest Study dates: November 2004‐January 2014 Note:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study; not feasible to blind personnel to treatment group |
Blinding of outcome assessors (detection bias) All outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss of 4 participants in the intervention group, because no treatment was given. Study authors do not report reasons for no treatment. ITT analysis not used. Although overall loss is < 10%, all losses are in the intervention group |
Selective reporting (reporting bias) | Unclear risk | Prospective clinical trial registration or prepublished protocol not reported; not feasible to assess risk of reporting bias |
Other bias | Low risk | Study authors noted that participants in the propranolol group had a higher percentage of TBSA; however, because of other burn measurements, study authors believed that severity of burns was equivalent between groups |