Methods | Randomised controlled trial. | |
Participants | Consenting male and female patients who had not received antibiotics in the preceding 2 days. PEG tube inserted for CVA (n= 57), dementia (n= 10), neurogenic dysphagia (n= 11) and miscellaneous (n= 18). Excluded if on antibiotic therapy, unable to gain consent, had allergy to cephalosporin or iodine, or required prophylaxis for endocarditis. Total number of patients randomised; n = 96. |
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Interventions | 'Pull' technique. Group 1: cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34); Group 2: povidone‐iodine spray only (n = 28); Group 3: povidone‐iodine spray and cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34). | |
Outcomes | Peristomal infection. Mortality. Logistic regression effects of diabetes, steroids, acid suppressants, age and sex. | |
Notes | Used Jain et al wound assessment. Some patients received antibiotics during follow‐up period. Country of origin: England. Power calculation not performed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Closed envelopes opened at random by an endoscopy nurse. |
Allocation concealment (selection bias) | Low risk | 'Closed envelopes that were shuffled and opened at random by an endoscopy nurse after the patient had given consent for the study'. |
Blinding (performance bias and detection bias) Blinding patient | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Blinding care provider | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Blinding outcome assessor | Low risk | Stomal site inspected by the investigator who was blinded to regime. |
Incomplete outcome data (attrition bias) Drop outs/withdrawals | Low risk | No drop outs, five patient deaths in 1 week, 1 from gastric leakage on day 6 (5.2%). |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes addressed. |
Baseline imbalance? (Was the study free of baseline imbalance?) | Low risk | All groups were balanced for age, gender, steroids, diabetes, size of PEG tube, reasons for PEG. |
Timing of outcome assessment similar in all groups? | Low risk | Outcomes in both groups were assessed on day three or four and day seven. |