Yarboro 2013.
Methods | Country where data collected: USA Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: |
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Participants | Inclusion criteria: superficial partial‐thickness burns, 0‐4 days post thermal injury < 25% TBSA, aged 11‐80 years Exclusion criteria: burn on face, ears or scalp; allergic to silver Participants: 24 participants attending a wound management centre Mean age (years): 33.8 vs 33.9 Male participants: 18/24 Burn type: NR Burn degree: NR (superficial partial‐thickness) Burn size (%TBSA): NR (area burned 1103.10 ± 1086.10 cm² vs 753.70 ± 934.30 cm²) Burn location: NR |
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Interventions | Intervention arm 1: Aquacel Ag plus standard care Intervention arm 2: SSD plus standard care Cointerventions: whirlpool wound cleansing for 15 mins using hexaclorophene + selective debridement followed by wound dressing as per arm and 2nd dressing |
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Outcomes | Primary outcome: wound healing 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: "Twenty‐four subjects (18 men and 6 women) who sustained superficial partial‐thickness burns and who were between the ages of 19 and 53 years, and with time of injury from 0 to 4 days, were randomly assigned into a control group (silver sulfadiazine) and experimental group (Aquacel Ag)." Comment: no further information on how the randomisation sequence was produced |
Allocation concealment (selection bias) | Unclear risk | Quote: "Twenty‐four subjects (18 men and 6 women) who sustained superficial partial‐thickness burns and who were between the ages of 19 and 53 years, and with time of injury from 0 to 4 days, were randomly assigned into a control group (silver sulfadiazine) and experimental group (Aquacel Ag)." Comment: no information on whether treatment allocation concealment was adequate |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Wound measurements were assessed at the time of the initial examination and every 4 days subsequently until the area was re‐epithelialized 100%. To ensure objectivity, the burn area was measured digitally with the software program Aspyra (AspyraLLC; Blue Springs, Missouri) in order to prevent discrepancies in wound measurements. Length and width of wounds were assessed based on a clock face with length from 12 to 6 o'clock and width 3 to 9 o'clock based on anatomic position......In addition, pain, utilizing the standard 0‐ to 10‐point scale, was assessed at the conclusion of each treatment session" Comment: digital methods were used to assess wound healing but it was unclear if the assessors were blinded to treatment allocation; assessment of pain was also unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote "Twenty‐four subjects (18 men and 6 women) who sustained superficial partial‐thickness burns and who were between the ages of 19 and 53 years, and with time of injury from 0 to 4 days, were randomly assigned into a control group (silver sulfadiazine) and experimental group (Aquacel Ag)." Comment: no withdrawals were reported but it was unclear whether all randomised participants were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote, all outcomes mentioned in paper were reported in table |
Other bias | Unclear risk | Comment: frequency of additional treatments and if they differed between groups is not reported |