Neal 1981.
Methods | Country where data collected: UK Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: NR |
|
Participants | Inclusion criteria: people with blistered burns Exclusion criteria: burns on face, hands or feet or injury > 12 h before attendance Participants: 51 people attending the ED Mean age (years): children 3.4 ± 3 vs 2.4 ± 3; adults 39 ± 20 vs 40 ± 18 Male participants: 10 vs 12 Burn type: scald 23 vs 22; other 2 vs 4 Burn degree: NR Burn size (%TBSA): 1.83 ± 1.5 vs 1.58 ± 1 Burn location: NR |
|
Interventions | Intervention arm 1: paraffin gauze impregnated with chlorhexidine (Bactigras), covered by an absorbent dressing. N = 25 Intervention arm 2: plastic film (Opsite). N = 26 Cointerventions: removal of large blisters prior to treatment |
|
Outcomes | Primary outcome: wound healing Primary outcome: infection Secondary outcome: pain |
|
Notes | Funding NR | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A consecutive series of patients with blistered burns who attended the A/E Department were randomly selected to receive either a standard dressing or a plastic film." Comment: no information on how the randomisation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "A consecutive series of patients with blistered burns who attended the A/E Department were randomly selected to receive either a standard dressing or a plastic film." Comment: no information on whether the allocation was adequately concealed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The endpoint taken was when the wounds were dry and epithelialised, needing only a dry protective dressing. Bias was minimised by having a specific endpoint and using the confirmatory judgement of assessors not directly involved in trial." Comment: it appears that the assessors were blinded to treatment allocation for the outcome of healing. However it is unclear whether the assessments of pain (by participants) and infection (by healthcare professionals) were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Fig. 1 shows that most of the patients' wounds had healed within sixteen or seventeen days" Comment: Figure 1 and the table which accompanies it show cumulative healing for all 51 randomised participants. |
Selective reporting (reporting bias) | Low risk | Quote: ".....the following parameters were studied: the rate of healing, the rate of infection, and the degree of pain and social inconvenience." Comment: data were reported on all the prespecified parameters although it was not clear that planned methods for data management were followed |
Other bias | Unclear risk | Comment: no specific quote but no evidence of other sources of bias, but reporting insufficient to be certain |