Khalighi 2014.
Methods | 4‐arm RCT. Clean/contaminated (class 2) surgery | |
Participants | 1008 participants who underwent transvenous cardiac electronic implantable device insertions. Exclusion criteria: none reported Setting: hospital in Eason, Pennsylvania |
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Interventions | Intervention 1: povidone iodine ointment 10%, single dose applied immediately after closure. Intervention 2: neomycin ointment 3.5 mg/g, single dose applied immediately after closure. Control 1: non‐antibiotic, non‐antiseptic placebo (see authors additional notes below). Control 2: sterile non‐adherent pad applied immediately after closure (see authors additional notes below). |
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Outcomes | Surgical site inflammation/infection 4‐point grading system ( A‐B = inflammation, C‐D = infection); incidences of wound abscess or erosion of pacing system was part of grade D infection. Wounds with discharge were swabbed. Infection could occur up to 12 months after procedure. | |
Notes | Adverse effects: positive wound swab cultures Concurrent illness: diabetes mellitus, chronic kidney disease, malignancy, steroids (not specified), anticoagulation therapy (not specified) Quotes from direct correspondence with author: "In the ‘non‐antibiotic, non‐antiseptic arm of the trial’, these patients actually did not have an inert ointment applied to their wound, we used regular sterile gauze (4x4 gauze folded in half) as the dressing. The neomycin and iodine ointment arms received the same dressing,. The ‘sterile adherent pad’ arm only used "Telfa" (sterile non adherent pad) available commercially in most/all hospitals. "Patients classified as having grade 1 and grade 2 superficial inflammations (echemosis, oozing) were not considered as infection, since they ruled out to have infections (no discharge/no positive cultures/no 'ill looking' erythema)." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: study described as randomized, but method of random sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | Comment: not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: blinding was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome data were reported for all participants. Analysis was per ITT. |
Selective reporting (reporting bias) | Unclear risk | Comment: outcome data were presented for all outcomes listed in the methods section. Study protocol was not available for identification of any unreported outcomes. |
Other bias | Low risk | Comment: none were identified. |