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

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University Hospitals (UH)

Status and phase

Unknown
Phase 2

Conditions

Wound Infection

Treatments

Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00150852
04-012 (med 04-008)

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Central trial contact

Philippe De Saussure, MD; Alain Vonlaufen, MD

Data sourced from clinicaltrials.gov

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