Clinical Trials Logo

Clinical 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).


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00150852
Study type Interventional
Source University Hospital, Geneva
Contact Alain Vonlaufen, MD
Phone +41 22 372 93 40
Email Alain.Vonlaufen@hcuge.ch
Status Recruiting
Phase Phase 2
Start date September 2004

See also
  Status Clinical Trial Phase
Recruiting NCT02905955 - Vacuumtherapy After Venous Hybrid Procedures Phase 4
Not yet recruiting NCT02868372 - Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine N/A
Enrolling by invitation NCT02559453 - Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Active, not recruiting NCT01939145 - Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation Phase 4
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
Completed NCT00576745 - A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery Phase 1
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT02018094 - The Amputation Surgical Site Infection Trial (ASSIT) Phase 4
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Enrolling by invitation NCT02945761 - High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound N/A
Not yet recruiting NCT02882360 - Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum Phase 4
Enrolling by invitation NCT01977989 - Vancomycin in Spine Surgery Phase 4