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

Sponsored by: University Hospital, Geneva
Information provided by: University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00150852

Purpose

The aim of this study is to determine whether vancomycine with cefazoline is superior to vancomycine with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).
Condition Intervention Phase
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

Official Title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients : a Double-Blind, Randomized, Placebo-Controlled Study

Further Study Details: 
Primary Outcomes: Rate of PEG-site infection at 3, 7, 14, 21 and 28 days post intervention as assessed by a clinical score (Jain score) and swab culture
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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion

Exclusion Criteria:

  • 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00150852

Alain Vonlaufen, MD      +41 22 372 93 40    Alain.Vonlaufen@hcuge.ch
Philippe De Saussure, MD      + 41 22 372 93 40    Philippe.deSaussure@hcuge.ch

France
      Centre Hospitalier Universitaire (CHU), Grenoble,  38000,  France; Not yet recruiting
Agnès Plages  + 33 476 76 55 97    APlages@chu-grenoble.fr 
Xavier Roblin, MD,  Principal Investigator

Switzerland
      Division of Gastroenterology, University Hospital, Geneva,  1211,  Switzerland; Recruiting
Alain Vonlaufen, MD  + 41 22 372 93 40    alain.vonlaufen@hcuge.ch 
Philippe De Saussure, MD  + 41 22 372 93 40    Philippe.DeSaussure@hcuge.ch 
Alain Vonlaufen, MD,  Principal Investigator

Switzerland, Vaud
      Centre Hospitalier Universitaire Vaudois, Lausanne,  Vaud,  1011,  Switzerland; Not yet recruiting
Gian Dorta  + 41 21 314 11 11    Gian.Dorta@chuv.ch 
Gian Dorta, MD,  Principal Investigator

Study chairs or principal investigators

Alain Vonlaufen, MD,  Principal Investigator,  Division of Gastroenterology, University Hospital, Geneva   

More Information

Study ID Numbers:  04-012 (med 04-008)
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

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