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| Sponsored by: |
University Hospital, Geneva |
|---|---|
| Information provided by: | University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00150852 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Wound Infection |
Drug: Vancomycin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study |
| Estimated Enrollment: | 96 |
| Study Start Date: | September 2004 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alain Vonlaufen, MD | +41 22 372 93 40 | Alain.Vonlaufen@hcuge.ch |
| Contact: Philippe De Saussure, MD | + 41 22 372 93 40 | Philippe.deSaussure@hcuge.ch |
| France | |
| Centre Hospitalier Universitaire (CHU) | Not yet recruiting |
| Grenoble, France, 38000 | |
| Contact: Agnès Plages + 33 476 76 55 97 APlages@chu-grenoble.fr | |
| Principal Investigator: Xavier Roblin, MD | |
| Switzerland | |
| Division of Gastroenterology, University Hospital | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Alain Vonlaufen, MD + 41 22 372 93 40 alain.vonlaufen@hcuge.ch | |
| Contact: Philippe De Saussure, MD + 41 22 372 93 40 Philippe.DeSaussure@hcuge.ch | |
| Principal Investigator: Alain Vonlaufen, MD | |
| Switzerland, Vaud | |
| Centre Hospitalier Universitaire Vaudois | Not yet recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Gian Dorta + 41 21 314 11 11 Gian.Dorta@chuv.ch | |
| Principal Investigator: Gian Dorta, MD | |
| Principal Investigator: | Alain Vonlaufen, MD | Division of Gastroenterology, University Hospital, Geneva |
More Information
| Study ID Numbers: | 04-012 (med 04-008) |
| Study First Received: | September 6, 2005 |
| Last Updated: | December 28, 2005 |
| ClinicalTrials.gov Identifier: | NCT00150852 |
| Health Authority: | Switzerland: Swissmedic |
|
Gastrostomy Wound infection Antibiotic prophylaxis |
|
Methicillin Wounds and Injuries Vancomycin Disorders of Environmental Origin Wound Infection |
|
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |
