Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Phase 3
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00981110
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
- Age 18-75
- Informed signed consent
- Performance Status 0-2 (according to ECOG score)
- Platelets > 50.000/mm3
- Prothrombin Time (Quick) > 60%
- White Blood Cells > 2500/mm3
- Life Expectancy > 3 months
Exclusion Criteria
- Intestinal obstruction
- Severe intestinal bleeding requiring blood transfusion
- Age under 18 or over 75
- Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
- Renal failure (hemodialysis, creatinin > 2.5 mg/dL)
- Active infections
- Coagulopathy
- Inability to give an informed consent
- Known allergies to dressing components
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The rate of patients with a Surgical site infection 30 days after surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
European Institute of Oncology
🇮🇹Milan, Italy
S. Gerardo Hospital
🇮🇹Monza, Italy
European Institute of Oncology🇮🇹Milan, Italy