Moshakis 1984.
Methods | 2‐arm RCT undertaken in the UK | |
Participants | People undergoing the excision of a breast lump | |
Interventions | Group A (n = 59): dry gauze; 4–6 gauze dressings secured in place by 4 cm strips of tape (Transpore or Elastoplast, 3M Healthcare). Removed 1 day postoperatively and inspected; drain removed; a new dressing applied. Participants provided with dressings to take home, if further changes required. Group B (n = 61): transparent film (polyurethane membrane) dressing (Tegaderm, 3M Healthcare) left intact until day 6–8 for suture removal. If drain present, dressing was split along the length of the drain and it was removed. Any serious fluid collection was aspirated, and puncture covered with Transpore. | |
Outcomes | Primary review outcome: not reported Secondary review outcomes: pain (assessed by participant on a linear scale); acceptability (assessed by participant on a linear scale also assessed by nurse on the same scale). Cost, scarring and ease of removal not reported. |
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Notes | Trial outcome data: see Table 12 Follow‐up: nurse assessment of the wound took place before discharge, normally 1 day postoperatively. Participants gave their wound assessments at an outpatient visit (normally 6‐8 days postoperatively). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "..they were randomly allocated to receive.." However, some patients were undergoing excision of bilateral breasts lumps. In this case each wound was allocated to a different dressing. Therefore, some participants were their own control and some were not. Comment: unclear process |
Allocation concealment (selection bias) | Unclear risk | "To diminish bias, allocation of the dressing to each patient was not known to the surgeon until the end of the operation" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention of blinding in the trial report |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up: 5 at outpatient follow‐up |
Selective reporting (reporting bias) | Low risk | Given the information presented in the paper, all prespecified outcomes reported. |
Other bias | High risk | Lack of baseline data. Analysis did not acknowledge the lack of independence in wounds on the same person. |