Wound InfectionPhase 2NCT00150852
Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
A Phase 2 study testing Vancomycin in people with Wound Infection, run by University Hospital, Geneva at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection
- What is being tested?
- Vancomycin
- How many people
- 96 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Division of Gastroenterology, University Hospital
Geneva, Canton of Geneva, 1211
Alain Vonlaufen, MD, + 41 22 372 93 40, alain.vonlaufen@hcuge.ch
Philippe De Saussure, MD, + 41 22 372 93 40, Philippe.DeSaussure@hcuge.ch
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Gian Dorta, + 41 21 314 11 11, Gian.Dorta@chuv.ch
Gian Dorta, MD
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire (CHU)
Grenoble, 38000
Agnès Plages, + 33 476 76 55 97, APlages@chu-grenoble.fr
Xavier Roblin, MD
About this study
Official title: Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study
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).
Read the 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.
- Conditions
- Wound Infection
- Being tested
- Vancomycin
- Keywords
- Gastrostomy, Wound infection, Antibiotic prophylaxis
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Alain Vonlaufen, MD, Principal investigator, Division of Gastroenterology, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150852
- Sponsor's protocol ID
- 04-012 (med 04-008)
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 29 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00150852
- Acronym / sponsor ID
- 04-012 (med 04-008)
- Conditions
- Wound Infection
- Keywords
- Gastrostomy, Wound infection, Antibiotic prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin | Drug | – |
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
1 secondary outcome
Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2005.
Related trials for Wound Infection
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Vonlaufen, MD principal investigator
Division of Gastroenterology, University Hospital, Geneva
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin in people with Wound Infection, run by University Hospital, Geneva at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Vonlaufen, MD (+41 22 372 93 40, Alain.Vonlaufen@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2005; AzTrials last refreshed its copy on 8 Nov 2026.