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

NCT ID: NCT00150852

Last Updated: 2005-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Wound Infection

Keywords

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Gastrostomy Wound infection Antibiotic prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Vancomycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Principal Investigators

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Alain Vonlaufen, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology, University Hospital, Geneva

Locations

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Centre Hospitalier Universitaire (CHU)

Grenoble, , France

Site Status NOT_YET_RECRUITING

Division of Gastroenterology, University Hospital

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status NOT_YET_RECRUITING

Countries

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France Switzerland

Central Contacts

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Alain Vonlaufen, MD

Role: CONTACT

Phone: +41 22 372 93 40

Email: [email protected]

Philippe De Saussure, MD

Role: CONTACT

Phone: + 41 22 372 93 40

Email: [email protected]

Facility Contacts

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Agnès Plages

Role: primary

Alain Vonlaufen, MD

Role: primary

Philippe De Saussure, MD

Role: backup

Gian Dorta

Role: primary

Other Identifiers

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04-012 (med 04-008)

Identifier Type: -

Identifier Source: org_study_id