Dormann 2000

Methods	Randomised controlled trial.
Participants	Male and female patients aged over 18 years requiring enteral feeding via PEG tube > six weeks. PEG tube inserted for neurological disease (n= 145), tumour (n= 63) and other (n= 8). (Taken from Table 1 ‐ 216 patients evaluable as 21 dropouts). Excluded if signs of infection, peritonitis ascites, peritoneal malignancy, prior gastric/bowel disease, granulocytopenia, previous radio/chemotherapy, antibiotic treatment within previous 72 h, clotting/platelet disorders, sensitivity to ceftriaxone. Total number of patients randomised; n = 237.
Interventions	'Pull' technique: Group 1: ceftriaxone 1 g IV 30 min prior to PEG (n = 106); Group 2: no placebo, no antibiotic (n = 110). Numbers originally randomised into groups not given in trial report.
Outcomes	Peristomal infection. Mortality. Cost of antibiotic therapy. Post‐intervention antibiotic therapy.
Notes	Used modified Jain et al criteria for wound assessment. Data from four previous studies incorporated into this study. Data from previous study (1999a), sponsored by Hoffman La Roche, incorporated into this study. Conducted in 12 secondary and tertiary medical centres. Country of origin: Germany. Power calculation performed.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised in blocks of four using Rancode 3.1.
Allocation concealment (selection bias)	Unclear risk	Not stated.
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	Unclear risk	'Study monitors' involved but specific role not stated.
Incomplete outcome data (attrition bias) Drop outs/withdrawals	Low risk	21 drop outs (8.9%).
Selective reporting (reporting bias)	Low risk	Prespecified outcomes addressed.
Baseline imbalance? (Was the study free of baseline imbalance?)	Low risk	Both groups balanced for gender, age, reasons for PEG tube, BMI,indications for PEG, underlying conditions.
Timing of outcome assessment similar in all groups?	Low risk	Outcomes in both groups were assessed at one, two, four and ten days (mean 8.7).