Varas 2005.
Methods | Country where data collected: USA Parallel‐group RCT (intra‐individual) Unit of randomisation: burn Unit of analysis: burn Duration: completion of treatment (max 14 days) |
|
Participants | Inclusion criteria: partial‐thickness burn injuries requiring topical wound care that, in the opinion of the observer, would not go on to require surgical excision and grafting. The wounds had to involve two areas far enough apart so as not to create interference of the treatments. Wounds of similar sizes were chosen, but not specifically measured. Exclusion criteria: NR Participants: 14 people attending a hospital/burn centre Mean age (years): 41 (25‐68) Male participants: 13/14 Burn type: 12 flame, 2 scalding (both arms same cause) Burn degree: NR partial‐thickness Burn size (%TBSA): 14.6% (4.5–27) Burn location: upper extremities 8 vs 8, lower extremities 4 vs 6, trunk 2 vs 0 |
|
Interventions | Intervention arm 1: Acticoat‐ silver‐impregnated membrane applied wet and left in place; moistened and change of overlying dry gauze dressings every 6 h. 14 burns Intervention arm 2: SSD ‐ applied and removed then dressed with a dry gauze dressings twice daily. 14 burns Cointerventions: NR |
|
Outcomes | Primary outcome: wound healing Secondary outcome: pain Secondary outcome: adverse events |
|
Notes | Funding NR This was a "split‐body" or "intra‐individual" design where a person with two wounds had one wound randomised to each treatment. It was not clear whether the analysis took account of this. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by assignment using random drawing of sealed envelopes from a box with equal numbers of treatment and control envelopes. According to the protocol, the patient’s most left and/or upper‐most wound was labelled as wound #1, and the patient’s most right and/ or lower‐most wound was labelled as wound #2. Wound #1 was assigned randomly to one of the treatment algorithms, and wound #2 was assigned to the alternate algorithm." Comment: randomisation appeared adequate |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was performed by assignment using random drawing of sealed envelopes from a box with equal numbers of treatment and control envelopes. According to the protocol, the patient’s most left and/or upper‐most wound was labelled as wound #1, and the patient’s most right and/ or lower‐most wound was labelled as wound #2. Wound #1 was assigned randomly to one of the treatment algorithms, and wound #2 was assigned to the alternate algorithm." Comment: it was unclear how well the allocation system was concealed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "endpoint for dressings both in the inpatient and outpatient setting was based on the clinical judgment of the attending physicians at the Burn Center" Comment: unclear whether the outcome assessor was blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Fourteen patients were enrolled .....Four patients continued in the study until completion of treatment" Comment: very high proportion of participants did not complete treatment |
Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but outcomes were not clearly specified in methods section so difficult to determine if all assessed outcomes reported |
Other bias | Unclear risk | Comment: unclear whether the analysis adjusted for intra‐individual design |