Glat 2009.
| Methods | Country where data collected: USA Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 21 days + |
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| Participants | Inclusion criteria: age: 2 months–18 years; enrolment: < 36 h post‐injury; burn severity: superficial to mid‐dermal, TBSA 1%‐40% Exclusion criteria: electrical or chemical burns; deep or full‐thickness burns; previous antimicrobial or enzymatic debridement; death likely within study period; enrolment in a previous study; pregnancy Participants: 24 children attending a paediatric hospital; mixture of inpatients and outpatients Mean age (months): 22.8 vs 43.0 Burn size (%TBSA): TBSA 1%‐10% (stated as being “comparable” between treatment arms) All other characteristics NR |
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| Interventions | Arm 1: SSD cream (Silvadene, 10 mg) 1/16” (1.6 mm) thickness every 2‐3 days Arm 2: silver hydrogel (SilvaSorb), 1/16” (1.6 mm) thickness every 2‐3 days Cointerventions: initial blister fluid drainage. Cream/gel covered with non‐adherent dressing, rolled gauze and Elasti‐net. Participants or parents were allowed to change wound dressings in outpatient cases. |
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| Outcomes | Primary outcome: wound healing: time to complete wound healing (mean time to (full) re‐epithelialisation) Primary outcome: wound healing: proportion of wounds completely healed during follow‐up ((full) re‐epithelialisation at 21 days Secondary outcome: adverse events Secondary outcome: resource use (number of dressing chances) Secondary outcome: pain (during dressing changes, measured using the Wong‐Baker Faces Pain Scale/observational pain assessment scale in infants or toddlers) |
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| Notes | Funding: Drexel University School of Medicine by Medline Industries | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote “Patients were randomly assigned to a protocol of care that included either SSD cream or SilvaSorb Gel” Comment: no further details on method of randomisation |
| Allocation concealment (selection bias) | High risk | Quote: ”patients were randomly assigned to a protocol of care… without blinding of the physician investigator or other medical personnel to the type of treatment” Comment: states that physicians and other personnel were aware of treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: ”patients were randomly assigned to a protocol of care … without blinding of the physician investigator or other medical personnel to the type of treatment” Comment: mentions (unblinded) physicians as investigators, no mention of any independent assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 24 participants enrolled, mean/median/SD data for 4 stated outcomes reported for all participants |
| Selective reporting (reporting bias) | Unclear risk | Quote: “Study endpoints that were recorded included the following…” Comment: wording implies that there may have been other end points, though data are given for the stated endpoints |
| Other bias | Low risk | No direct quote. no evidence of other sources of bias and study methods reasonably well reported |