Clinical trial NCT00150852: Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
Official title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wound Infection
Keywords: Gastrostomy
Wound infection
Antibiotic prophylaxis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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 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

Primary outcomes:
measure: 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:
measure: Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire (CHU)
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
city: Geneva
country: Switzerland
facility: Division of Gastroenterology, University Hospital
Study officials:
affiliation: Division of Gastroenterology, University Hospital, Geneva
name: Alain Vonlaufen, MD
role: PRINCIPAL_INVESTIGATOR
References: