Caruso 2006.
| Methods | Country where data collected: USA Parallel‐group RCT (stratified by TBSA and age) Unit of randomisation: participant Unit of analysis: participant Duration: 21 days |
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| Participants | Inclusion criteria: age ≥ 2 months; superficial, mid‐dermal, or mixed partial‐thickness burns, 5%‐40% TBSA, within 36 h of enrolment. Randomisation stratified by TBSA (5%‐20% or > 20% ‐40%) and age (0‐3 years or ≥ 4 years) Exclusion criteria: pregnancy; electrical, chemical, or frostbite burns; areas of burn likely to require excision/grafting; antibiotic use in 2 days prior to burn injury; evidence of inhalation injury; fractures and/or neurological injury. Participants: 84 hospital or clinic outpatients (unclear if some inpatients also included) Mean age (years): 29.4 vs 24.0 years Male participants: 27/42 vs 30/40 Burn type: scald 27/42 vs 18/40; flash 9/42 vs 13/40; flame 4/42 vs 8/40; contact, 0 vs 1; other 2 vs 0 Burn degree: superficial and mid‐dermal (N = NR) Burn size (%TBSA): 12.0% vs 10.8% (superficial 4.8% vs 4.2%; mid‐dermal BSA 8.8% vs. 8.1%) Burn location:NR |
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| Interventions | Intervention arm 1: silver hydrofibre dressing (AQUACEL Ag Hydrofiber, 1.2% weight ionic silver). Dressing overlapped wounds by 4‐5 cm. Applied in hospital/clinic on day 1 and every 2‐3 days for 21 days. Dressing covered with gauze and retention dressings. (N = 42) Intervention arm 2: SSD cream (Silvadene, 1%). 1/16” (1.6 mm) thick application. Outer dressing and dressing changes per package insert but “at least once daily”. Home dressing changes permitted between clinic visits. (N = 42) Cointerventions: procedural medications & opiates where indicated |
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| Outcomes | Primary outcome: wound healing (proportion of participants with full epithelialisation) Primary outcome: infection Secondary outcome: resource use (frequency of dressing changes) Secondary outcome: pain (VAS) |
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| Notes | Patient characteristic data refers to participants included in analysis, not numbers randomised (2 participants from 1 group excluded) Funding: ConvaTec, a BristolMyers Squibb company (manufacturer of silver dressing) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Patients were assigned randomly to a protocol of care that included either AQUACEL® Ag dressing or silver sulfadiazine. The randomization schedule was stratified by extent of burns (5% to 20% or _20% to 40% of TBSA) and age (0–3 years or 4 years and older)” Comment: no details on how randomisation schedule was produced |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were assigned randomly to a protocol of care that included either AQUACEL® Ag dressing or silver sulfadiazine” Comment: no information on allocation concealment is mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: “Study treatment was not blinded”; “Outcomes were measured at every in‐clinic dressing change until study completion or premature study discontinuation” Comment: Blinding in relation to clinical outcome assessment was not mentioned. Healthcare cost analysis was performed by an independent group but no mention of blinding. Participants weren't blinded and outcomes were assessed at in‐clinic dressing change when group assignment would have been apparent based on the dressing. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “In the AQUACEL® Ag dressing group, all 42 patients were included in the safety and intent‐to‐treat analyses. In the silver sulfadiazine group, 40 of 42 patients were included in the safety and intent‐to‐treat analyses because 2 patients did not receive study treatment. Comment: although there was incomplete data for pain and long‐term follow‐up all participants were accounted for in the ITT wound healing analysis |
| Selective reporting (reporting bias) | Unclear risk | Comment: No direct quote but the outcomes to be assessed were not prespecified in the methods so it is unclear whether they were fully reported |
| Other bias | Unclear risk | Comment: No direct quote but no evidence of other sources of bias although high levels of manufacturer involvement were noted |