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Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150852
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : September 8, 2005
Last Update Posted : December 29, 2005
Information provided by:
University Hospital, Geneva

Brief Summary:
The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

Condition or disease Intervention/treatment Phase
Wound Infection Drug: Vancomycin Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 or 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 from the standard pull technique proposed by the physician in charge and the gastroenterologist
  • Patients requiring antibiotic prophylaxis of endocarditis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150852

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Contact: Alain Vonlaufen, MD +41 22 372 93 40
Contact: Philippe De Saussure, MD + 41 22 372 93 40

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Centre Hospitalier Universitaire (CHU) Not yet recruiting
Grenoble, France, 38000
Contact: Agnès Plages    + 33 476 76 55 97   
Principal Investigator: Xavier Roblin, MD         
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Gian Dorta    + 41 21 314 11 11   
Principal Investigator: Gian Dorta, MD         
Division of Gastroenterology, University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Alain Vonlaufen, MD    + 41 22 372 93 40   
Contact: Philippe De Saussure, MD    + 41 22 372 93 40   
Principal Investigator: Alain Vonlaufen, MD         
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Alain Vonlaufen, MD Division of Gastroenterology, University Hospital, Geneva

Layout table for additonal information Identifier: NCT00150852    
Other Study ID Numbers: 04-012 (med 04-008)
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 29, 2005
Last Verified: September 2005
Keywords provided by University Hospital, Geneva:
Wound infection
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Communicable Diseases
Wound Infection
Wounds and Injuries
Anti-Bacterial Agents
Anti-Infective Agents