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

Condition(s) targeted: Wound Infection

Intervention: Vancomycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Alain Vonlaufen, MD, Principal Investigator, Affiliation: Division of Gastroenterology, University Hospital, Geneva

Overall contact:
Alain Vonlaufen, MD, Phone: +41 22 372 93 40, Email: Alain.Vonlaufen@hcuge.ch

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).

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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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 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

Alain Vonlaufen, MD, Phone: +41 22 372 93 40, Email: Alain.Vonlaufen@hcuge.ch

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

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

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

Starting date: September 2004
Last updated: December 28, 2005