Martin‐Trapero 2013.
Methods | 2‐arm RCT undertaken in Spain | |
Participants | People diagnosed with cholelithiasis undergoing elective laparoscopic cholecystectomy Exclusion criteria: > 70 years of age; diabetes; having a fever; and current treatment with immunosuppressants |
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Interventions | Group A (n = 101): non‐occlusive dressing (gauze) Group B (n = 96): 0.2% polyhexamethylene biguanide (PHMB) dressing The disinfection of the skin prior to surgery was performed 2 times with a solution of povidone iodine. A single dose of prophylaxis antibiotics was given at anaesthetic induction. Metal staples were used to close the surgical wound. Once incisions closed the wound was cleaned with povidone‐iodine 0.01% and the gauze or PHMB dressing was applied. |
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Outcomes | Primary review outcome: SSI (CDC definition) Secondary review outcomes: none (based on translation) |
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Notes | Trial outcome data: see Table 12 Information extracted from English abstract and limited translation of methods and results Follow‐up: 30 days |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Based on translation "....were assigned by an automatic method after the preparation of a spreadsheet (MS Excel) using the function ‐random tool where the researcher did not know the allocation of the next patient to be included in the study (concealment of random allocation)" |
Allocation concealment (selection bias) | Low risk | Based on translation "....were assigned by an automatic method after the preparation of a spreadsheet (MS Excel) using the function ‐random tool where the researcher did not know the allocation of the next patient to be included in the study (concealment of random allocation)" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not able to assess |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not able to assess |
Selective reporting (reporting bias) | Unclear risk | Not able to assess |
Other bias | Unclear risk | Not able to assess |