Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The rate of patients with a Surgical site infection
Outcome Time Frame:
30 days after surgery
Safety Issue:
Yes
Principal Investigator
Bruno Andreoni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
European Institute of Oncology
Authority:
Italy: The Italian Medicines Agency
Study ID:
IEO S402/208
NCT ID:
NCT00981110
Start Date:
June 2008
Completion Date:
December 2010
Related Keywords:
- Colorectal Cancer
- Surgical site infections (SSI)
- Advanced antimicrobial dressing and clean surgery
- Hydrofibre dressing
- Colorectal Neoplasms
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