title: Systemic Prophylactic Antibiotics for the Modified Introducer Method for Percutaneous Endoscopic Gastrostomy: A Prospective, Randomized, Double-Blind Study.
abstract: Percutaneous endoscopic gastrostomy (PEG) is the most common method of enteral nutrition in patients who require long-term tube feeding. According to meta-analyses, administration of systemic prophylactic antibiotics for PEG reduces peristomal infection. However, with several recent developments in the procedure and instruments, the risk of infection might have been reduced. The aim of this study was to evaluate the use of systemic antibiotic prophylaxis for a modified introducer method of PEG.
  
  
  
  This prospective, randomized, double-blind trial assessed 278 patients undergoing PEG for inclusion. Ninety-one patients with an indication for PEG who gave informed consent to participate were randomized. Forty-six patients received prophylactic ampicillin and 45 patients received a placebo. A modified introducer method of PEG using a Seldinger PEG kit was performed. The primary outcome was the occurrence of clinically evident wound infection within 3 days after PEG.
  
  
  
  Wound infection within 3 days was observed in none in the prophylaxis group and in 1 patient in the control group (P=0.4945). There was no significant difference between 2 groups in the other parameters, including peristomal infection within 7 days, overall infection, white blood cell counts, C-reactive protein level, and successive rate of finishing antibiotics.
  
  
  
  For wound infection within 3 days, noninferiority of the placebo group to the antibiotics group was preliminarily suggested with our criteria, but not for peristomal infection within 7 days. More strict criteria for noninferiority should be examined in a further large sample study.
authors.affiliation: *Department of Internal Medicine, Division of Gastroenterology, Sapporo Shirakaba-dai Hospital †Department of Gastroenterology, Rheumatology, and Clinical Immunology, Sapporo Medical University, Sapporo, Hokkaido, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Adachi
authors.forename: Kimishige
authors.initials: K
authors.lastname: Akino
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Mita
authors.forename: Takefumi
authors.initials: T
authors.lastname: Kikuchi
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yamashita
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Arimura
authors.forename: Takao
authors.initials: T
authors.lastname: Endo
mesh_terms: D000368:Aged; D000667:Ampicillin / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D004311:Double-Blind Method; D004750:Enteral Nutrition; D004940:Esophageal Stenosis / Q000601:surgery*; D005260:Female; D005773:Gastroscopy / Q000379:methods; D005774:Gastrostomy / Q000379:methods; D006801:Humans; D007564:Japan; D008297:Male; D011183:Postoperative Complications; D011446:Prospective Studies; D013530:Surgical Wound Infection; D016896:Treatment Outcome
chemical_list: D000667:Ampicillin