Wright 1993.
| Methods | Country where data collected: UK Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: NR |
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| Participants | Inclusion criteria: partial‐thickness burns manageable through outpatients Exclusion criteria: burns requiring grafting, > 48 h post‐burn injury, sensitive to dressings, burn on face or hand joints, burn infected, receiving treatment other than first aid or more suited to alternative treatments Participants: 98 people presenting at ED/outpatient care. Other characteristics NR but "no statistically significant differences with regard to patient demographics and physical characteristics" (refers to participants included in analysis only) |
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| Interventions | Intervention arm 1: hydrocolloid dressing (Granuflex) Intervention arm 2: paraffin gauze impregnated with 0.5% chlorhexidine acetate (Bactigras) Cointerventions: cleaned with sodium chloride solution and allowed to dry |
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| Outcomes | Secondary outcome: pain Secondary outcome: resource use |
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| Notes | Funded by ConvaTec Ltd | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Written, informed consent of the patients was obtained and witnessed, and the patients were randomly allocated to either Granuflex E or Bactigras" Comment: no further information on how the randomisation sequence was produced |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Written, informed consent of the patients was obtained and witnessed, and the patients were randomly allocated to either Granuflex E or Bactigras" Comment: no further information on whether allocation was adequately concealed |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "At each follow‐up attendance the following details were noted: 1. Reason for dressing change. 2. Ease of removal. 3. Wound appearance. 4. Pain while dressing was in situ. 5. Pain on dressing removal or application. 6. Analgesia or antibiotics administered. When the wound had completely healed a final evaluation was made, the quality of healing with regard to re‐epithelialization and cosmetic results was noted. The dressing was rated by both the investigator and the patient." Comment: it appeared that the investigator was not blinded to treatment allocation and also performed the assessment of outcome |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Out of a total of 98 patients involved, 31 patients were withdrawn. Of these, 22 patients were lost to follow‐up, two patients requested withdrawal and there was one protocol violation." Comment: a large number of participants were lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Comment: no specific quote but outcomes were not fully prespecified so difficult to determine if all planned outcomes were reported |
| Other bias | Unclear risk | Comment: no evidence of other sources of bias but reporting insufficient to be certain |