Ko 1992.
Study characteristics | ||
Methods | QRCT | |
Participants | 1980 adults having cardiopulmonary bypass surgery in the USA between July 1987 and June 1989 | |
Interventions | Group 1: hair removal with razor (n = 990) Group 2: hair removal with a clipper (n = 990) Product details: no details are given for the razor, the clippers were Remington, 3M. Timing of hair removal: the night before surgery for elective cases, and immediately before surgery for emergency cases. Hair removed by: not specified. Venue for hair removal: not reported for elective surgery, the operating table for emergency cases. |
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Outcomes | Outcome: suppurative mediastinitis (the authors use this term interchangeably with sternal wound infection). Definition included; pain, fever, erythema, purulent drainage, sternal instability, tenderness, and leukocytosis. Needle aspiration sometimes used to assist diagnosis. Wounds were examined by the surgical team at least twice a day. 1 infection was diagnosed at the 30‐day postoperative follow‐up visit. No other details are given regarding assessment. |
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Notes | Participants were also randomised to receive either saline or povidone iodine intraoperative irrigation. No funding sources mentioned. No details of conflict of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "according to the last two digits of their hospital numbers" Comment: inadequate randomisation technique. |
Allocation concealment (selection bias) | High risk | Quote: "according to the last two digits of their hospital numbers" Comment: care provider could predict allocation by reference to hospital number. |
Blinding (performance bias and detection bias) Care providers blinded | Unclear risk | Not reported. Comment: unclear whether care providers were blinded to intervention allocation. |
Blinding (performance bias and detection bias) Participants blinded | High risk | Not reported. Comment: participants would have been aware of hair removal method. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Wounds were examined by the surgical team twice a day. Comment: unclear whether assessors were blinded to intervention allocation. |
Incomplete outcome data (attrition bias) ITT analysis undertaken | Unclear risk | Not reported. Comment: no discussion of whether participants were analysed in groups to which they had been allocated. |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Unclear risk | Not reported. Comment: insufficient details to permit a judgement. |
Selective reporting (reporting bias) | Low risk | Main outcomes reported. Comment: unlikely to be affected by reporting bias. |
Other bias | Low risk | Comment: participant groups were equal or similar. |