Skip to main content
. 2013 Nov 14;2013(11):CD005571. doi: 10.1002/14651858.CD005571.pub3
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.
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.