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. 2019 Sep 26;2019(9):CD013438. doi: 10.1002/14651858.CD013438

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)
  • Age, mean (SD): 41 (± 14) years

  • Gender, M/F: 29/6

  • TBSA, mean (SD): 49% (± 18)


Control group (standard care)
  • Age, mean (SD): 38 (± 16) years

  • Gender, M/F: 30/4

  • TBSA, mean (SD): 59% (± 22)


Country: USA
Setting: single centre; hospital (burns unit)
Interventions Intervention group (propranolol)
  • Randomized, n = 39; losses = 4 (did not receive treatment); analysed, n = 35 (ITT analysis not used)

  • Details: started within 48 h of hospital admission, and continued throughout hospitalization to achieve a decrease in baseline HR by approximately 20%. Details of dose not given


Control group (standard care)
  • Randomized, n = 34; losses = 0; analysed, n = 34

  • Details: standard burn care management

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)
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:
  • we did not include length of stay data in the review, because data were reported separately for survivors and non‐survivors, and we were not certain whether data the time point was length of stay in hospital or length of stay in the burns unit.

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