Prevention of Gastrostomy-Related Wound Infection by Vancomycine in Carriers of Methicillin-Resistant Staphylococcus Aureus. - Article
Clinical Trial: Prevention of Gastrostomy-Related Wound Infection by Vancomycine in Carriers of Methicillin-Resistant Staphylococcus Aureus.
This study is currently recruiting patients.
Verified by University Hospital, Geneva September 2005
|Wound Infection || Drug: Vancomycine ||Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Secondary Outcomes: Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
Expected Total Enrollment: 96
Study start: September 2004
Percutaneous endoscopic gastrostomy (PEG) provides an enteral route for long-term nutrition in patients unable to swallow. Peristomal wound infection occurs in 5 - 30 % of patients. Systematic antibiotic prophylaxis by cephalosporins or ampicillin/clavulanic acid has been shown to prevent this complication efficiently.
MRSA-positive patients have been suggested to be at higher risk of PEG-related wound infection due to MRSA. However, recommendations about vancomycin-prophylaxis before surgical procedures have not been extended to PEG insertion. This might be due to the fact that the exact route of contamination is unknown. It is assumed that contamination occurs when gastrostomy tubes are passed through the oropharynx. However, oropharyngeal carriage appears less frequent than nasopharyngeal or cutaneous carriage. Furthermore, patients who receive PEG are particularly vulnerable to vancomycin toxicity because of older age and multiple comorbidities.
The aim of this study is to compare the rate of infectious complications after PEG insertion in patients colonized with MRSA who received either standard intravenous antibiotic prophylaxis associated with vancomycin or standard prophylaxis with placebo.
- PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion
- Age < 18 years
- No informed consent obtained either from the patient of from his legal representative
- Contraindication to the administration of cefazolin or of vancomycin
- Systemic administration of antibiotics effective against MRSA during the week prior to the procedure
- Technique of PEG insertion different fromt the standard pull technique proposed by the physician in charge and the gastroenterologist
- Patients requiring antibiotic prophylaxis of endocarditis
Location and Contact Information
Philippe De Saussure, MD + 41 22 372 93 40 Philippe.deSaussure@hcuge.ch
Centre Hospitalier Universitaire (CHU), Grenoble, 38000, France; Not yet recruiting
Xavier Roblin, MD, Principal Investigator
Division of Gastroenterology, University Hospital, Geneva, 1211, Switzerland; Recruiting
Philippe De Saussure, MD + 41 22 372 93 40 Philippe.DeSaussure@hcuge.ch
Alain Vonlaufen, MD, Principal Investigator
Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, 1011, Switzerland; Not yet recruiting
Gian Dorta, MD, Principal Investigator
Alain Vonlaufen, MD, Principal Investigator, Division of Gastroenterology, University Hospital, Geneva
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150852
Health Authority: Switzerland: Swissmedic
ClinicalTrials.gov processed this record on 2005-09-13
- Vancomycin-Intermediate/Resistant Staphylococcus aureus(VISA/VRSA) Infections (Centers for Disease Control and Prevention)