Silverstein 2011.
Methods | Country where data collected: USA Parallel‐group RCT (multicentre) Unit of randomisation: participant Unit of analysis: participant Duration: 21 days + |
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Participants | Inclusion criteria: aged at least 5 years; had a thermal burn within 36 h of enrolment; 2.5%‐20% of TBSA (burns covering between 3% and 25% of TBSA, allowing for up to 10% of TBSA to be third‐degree burn); only second‐degree burn area treated as per study protocol Exclusion criteria: chemical or electrical burn; clinically‐infected burn; treatment of the burn with an active agent before study entry, and pregnancy; necrotising leukocytic vasculitis or pyoderma gangrenosa, diagnosed illness (e.g. HIV/AIDS, cancer, severe anaemia); corticosteroid use; other immunosuppressants/chemotherapy in past 30 days; known allergy/hypersensitivity to components; physical/mental condition meaning not expected to comply Participants: 101 participants at 10 centres Mean age (years) (SE): 37.0 (18.1) vs 39.2 (18.2) Male participants: 36/41 Burn type: scald n=17 vs 9, flash 17 vs 16, flame 13 vs 19, contact 2 vs 4; other 0 vs 3 Burn degree: second‐degree Burn size (%TBSA): mean partial‐thickness burn size values used within the analysis, 5.64% vs 4.93%, Burn location: NR |
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Interventions | Intervention arm 1: silver soft silicone foam (Mepilex Ag). Dressing changes every 5‐7 days (3–5 days during the acute phase) depending on the status of the burn. Additional light bandage as needed to ensure fixation Intervention arm 2: SSD cream applied once or twice daily to a thickness of approximately 2 mm, then covered with a gauze pad and gauze wrap or other fixation Cointerventions: wound cleansing; sharp debridement at baseline |
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Outcomes | Primary outcome: wound healing Secondary outcome: adverse events Secondary outcome: pain Secondary outcome: costs |
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Notes | Funding: Molnlycke Health Care educational grant | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Enrolled subjects were assigned randomly to a treatment regimen that included either SSD or MAg. This was achieved through the use of sealed envelopes that were opened at the time of randomization. The randomization schedules were designed to ensure that equal numbers of patients were assigned to each treatment group at all participating centers.” Comment: no information on how randomisation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "This was achieved through the use of sealed envelopes that were opened at the time of randomization." Comment: although use of sealed envelopes was reported there is insufficient information to determine if the allocation was adequately concealed |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The study treatment was not blinded. .... Observation of dressings in both groups continued until 21 days postburn or until full reepithelialization occurred, alternative therapy for infection was initiated, or significant change in burn depth required surgical intervention. Sharp debridement was carried out at baseline visit only. Outcomes were measured at every scheduled visit: ie, days 0 (at inclusion in study), 7, 14, 21, and 35 (1 day) until study discontinuation." Comment: the outcome assessment did not appear to be blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no specific quote but all except 2 randomised participants were included in analyses with the exception of cost assessment where analysis of fewer participants was prespecified |
Selective reporting (reporting bias) | Low risk | Comment: no specific quote but outcomes were specified in detail and all were reported adequately |
Other bias | Low risk | Comment: no evidence of other sources of bias and well reported |