Shahzad 2013.
| Methods | Country where data collected: Pakistan Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: treatment duration until healing (longest 60 days); 2 months' follow‐up |
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| Participants | Inclusion criteria: 2nd‐degree burns presenting within 24 h of injury and TBSA < 25% Exclusion criteria: corrosive, electrical or chemical burns; history of diabetes, hypertension, epilepsy or kidney disease; pregnancy Participants: 50 people attending the ED and admitted to burns unit Mean age (years): 30.2 (15‐65); no significant difference between groups Male participants: 17 vs 9 Burn type: flame 16 vs 11; scald 9 vs 14 Burn degree: Burn size (%TBSA): 13.6 ± 4.7 (6‐25); no significant difference between groups Burn location: NR |
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| Interventions | Intervention arm 1: A vera gel twice daily. N = 25 Intervention arm 2: 1% SSD twice daily. N = 25 Cointerventions: 3rd generation cephalosporins; fluid resuscitation, shock prevention/treatment; wound cleansing with Pyodine scrub and normal saline |
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| Outcomes | Primary outcome: wound healing Primary outcome: infection Secondary outcome: pain |
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| Notes | Funding NR | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Fifty patients with second degree burns were randomized (consecutive sampling method) into 2 groups." Comment: no information on how randomisation sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Fifty patients with second degree burns were randomized (consecutive sampling method) into 2 groups." Comment: no information on whether allocation was adequately concealed |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "At the time of change of dressing details regarding the condition of the wound such as signs of wound infection, condition of surrounding unburned tissues, discharge, smell, necrotic tissue and state of epithelialisation was noted by on every 3rd day. ...... The patients and attendants were given information regarding the Aloe Vera gel and SSD cream. Tape method was used to measure length and width of the wound and then these measurements were multiplied i.e. Area (in centimetre square) = length x width." Comment: outcome assessment done at time of dressing change making it unblinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Among 25 patients treated with Aloe dressing, 24 patients had complete recovery while 1 had incomplete. In the SSD group, out of 25 patients, 19 patients had complete recovery and 6 had hypertrophic scar formation or the development of contractures" Comment: all randomised participants were included in the analysis |
| Selective reporting (reporting bias) | Unclear risk | Quote: "Patients were also reviewed for documentation of efficacy of treatment including time required for healing (epithelialization), pain scores, type of cultured organisms, wound colonization and infection, cost of treatment and mortality between both groups." Comment: all the planned outcomes were reported adequately |
| Other bias | Unclear risk | Comment: No evidence of other sources of bias, but reporting insufficient to be certain |