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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00150852
First received: September 6, 2005
Last updated: December 28, 2005
Last verified: September 2005
  Purpose

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 Intervention Phase
Wound Infection
Drug: Vancomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

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

Estimated Enrollment: 96
Study Start Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150852

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

Locations
France
Centre Hospitalier Universitaire (CHU) Not yet recruiting
Grenoble, France, 38000
Contact: Agnès Plages    + 33 476 76 55 97    APlages@chu-grenoble.fr   
Principal Investigator: Xavier Roblin, MD         
Switzerland
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Gian Dorta    + 41 21 314 11 11    Gian.Dorta@chuv.ch   
Principal Investigator: Gian Dorta, MD         
Division of Gastroenterology, University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Alain Vonlaufen, MD    + 41 22 372 93 40    alain.vonlaufen@hcuge.ch   
Contact: Philippe De Saussure, MD    + 41 22 372 93 40    Philippe.DeSaussure@hcuge.ch   
Principal Investigator: Alain Vonlaufen, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Alain Vonlaufen, MD Division of Gastroenterology, University Hospital, Geneva
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150852     History of Changes
Other Study ID Numbers: 04-012 (med 04-008)
Study First Received: September 6, 2005
Last Updated: December 28, 2005
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Gastrostomy
Wound infection
Antibiotic prophylaxis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Wounds and Injuries
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014