Perrins 1967.
Methods | Randomised clinical trial Study period: not stated |
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Participants | Inclusion criteria: every patient with split skin grafting Exclusion criteria: infants Baseline wound size: not stated Mean age (SD): not stated HBOT n = 24 Control n =24 Total number of patients = 48 Duration of follow‐up: 7 days Setting: Burns Unit, Queen Mary's Hospital, Roehampton, London, United Kingdom |
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Interventions | Intervention: HBOT treatment in a Vicker's clinical transparent pressure chamber, sessions of 100% O2 at 2 ATA for 2 hours, 1 day twice and the next 3 days once Comparison: usual care, clarification of usual care was not stated All cases had closed dressings of paraffin gauze, cotton wool and bandages applied to the operation and donor sites | |
Outcomes | Graft survival (defined as at least 95% take) at day 7 | |
Notes | Location: Queen Mary's Hospital, Roehampton, London, United Kingdom Setting: Burns Unit Financial support: not stated Estimating patches is not a reliable and validated outcome measurement |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were allotted randomly to treatment or control groups" Comment: insufficient information about the sequence generation process |
Allocation concealment (selection bias) | Unclear risk | Comment: the method of concealment is not described |
Blinding (performance bias and detection bias) Care provider blinding | Low risk | Quote: "routine surgery was performed by the surgeon, who did not know if the case was subsequently to be treated". Comment: probably done; surgeon is blinded |
Blinding (performance bias and detection bias) Outcome assessor blinding | Unclear risk | Comment: the surgeon who performed the operation was blinded, but it is not clear whether he was also the outcome assessor |
Blinding (performance bias and detection bias) Participant blinding | High risk | Comment: only the surgeon who performed the operation was blinded |
Incomplete outcome data (attrition bias) Was drop out rate described and acceptable | Low risk | Comment: there were no drop‐outs and all patients were assessed at the 6‐day follow‐up time point. |
Incomplete outcome data (attrition bias) ITT analysis | High risk | Comment: 2 grafts failed completely in the treated group. These 2 cases were excluded from analysis, on the grounds that a successful 'take' could not be expected. |
Selective reporting (reporting bias) | High risk | Comment: no protocol available, but percentage wound healing was measured at day seven with multiple sub‐endpoints. This increases the risk of a type 1 error. |
Other bias | Unclear risk | Comment: baseline comparability not stated; same treatment apart from intervention |