Vishwanath 2011.
| Methods | Randomised clinical trial Study period: not stated |
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| Participants | Inclusion criteria: (1) patients with a major defect requiring a free flap in which conventional techniques were considered as inapplicable or sub optimal and (2) fitness to undergo up to 12 hours of anaesthesia and surgery. Exclusion criteria: none reported Baseline wound size: not stated Mean age (SD): not stated HBOT n = 5 Control n = 5 Total number of participants = 10 Duration of follow‐up: 14 days |
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| Interventions | Intervention: HBOT treatment, sessions once a day for seven days (starting from the first postoperative day) at 2.5 ATA (type of chamber and duration not reported), Comparison: "usual care", clarification of usual care was not stated. | |
| Outcomes | Flap loss (i.e. unviable segment of tissue of any size in the flap) (number); Adverse effects; flap oedema and venous congestion. |
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| Notes | Location: INHS Asvini, Mumbai, India Setting: Department of surgery and reconstructive surgery, hospital Financial support: Research grants from the office of DGAFMS |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomised into two groups by random chit method" Comment: insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Comment: The method of concealment is not described |
| Blinding (performance bias and detection bias) Care provider blinding | High risk | Comment: The treatment and control groups are distinguishable for the patients |
| Blinding (performance bias and detection bias) Outcome assessor blinding | Unclear risk | Comment: Insufficient information to permit judgement |
| Blinding (performance bias and detection bias) Participant blinding | High risk | Comment: The treatment and control groups are distinguishable for the patients |
| 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 up to 14 days postoperatively |
| Incomplete outcome data (attrition bias) ITT analysis | High risk | Quote: "One flap each in groups 1 and 2 failed to survive beyond 24 hours of surgery. These patients were excluded from the analysis since flap loss had occurred even before HBO was exhibited to the case group" Comment: No ITT‐analysis was performed |
| Selective reporting (reporting bias) | Low risk | Comment: no protocol available; but the trial report list the outcomes of interest in both the methods and the results section |
| Other bias | Unclear risk | Comment: baseline comparable unclear; same treatment apart from intervention |