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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150852

Enrollment

Registered

2005-09-08

Start date

2004-09-30

Completion date

Unknown

Last updated

2005-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

Keywords

Gastrostomy, Wound infection, Antibiotic prophylaxis

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.

Interventions

DRUGVancomycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)	—

Countries

France, Switzerland

Contacts

Primary ContactAlain Vonlaufen, MD

Alain.Vonlaufen@hcuge.ch+41 22 372 93 40

Backup ContactPhilippe De Saussure, MD

Philippe.deSaussure@hcuge.ch+ 41 22 372 93 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026