Objective To evaluate a new and simpler strategy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG).
Design Single centre, two arm, randomised, controlled, double blind clinical trial.
Setting Endoscopy unit in Karolinska University Hospital, Stockholm, Sweden, between 3 June 2005 and 31 October 2009.
Participants 234 patients with an indication for PEG who gave informed consent to participate.
Intervention A single 20 ml dose of the oral solution of sulfamethoxazole and trimethoprim (also known as co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd, Basel, Switzerland) deposited in the PEG catheter immediately after insertion. The control group received standard prophylaxis consisting of a single intravenous dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline, London) administered before insertion of the PEG tube.
Main outcome measure Primary outcome was the occurrence of clinically evident wound infection within 14 days after insertion of the PEG catheter. Secondary outcomes were positive bacterial culture and blood tests (highly sensitive C reactive protein and white blood cell count). All randomised patients were included in an intention to treat analysis.
Results Of the 234 patients included in this study, 116 were randomly assigned to co-trimoxazole and 118 to cefuroxime. At follow-up 7-14 days after insertion of the PEG catheter, wound infection was found in 10 (8.6%) patients in the co-trimoxazole group and 14 (11.9%) in the cefuroxime group, which corresponds to a percentage point difference of −3.3% (95% confidence interval −10.9% to 4.5%). The per protocol analysis, which comprised 100 patients in each group, gave similar results—10% and 13% infection in the co-trimoxazole and cefuroxime groups, respectively (percentage point difference −3.0%, 95% CI −11.8% to 5.8%). Both these analyses indicate non-inferiority of co-trimoxazole compared with cefuroxime because the upper bounds of the confidence intervals are lower than the pre-determined non-inferiority margin of 15%. Analyses of the secondary outcomes supported this finding.
Conclusion 20 ml of co-trimoxazole solution deposited in a newly inserted PEG catheter is at least as effective as cefuroxime prophylaxis given intravenously before PEG at preventing wound infections in patients undergoing PEG.
Trial registration Current Controlled Trials ISRCTN18677736.