Status:
COMPLETED
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Lead Sponsor:
European Institute of Oncology
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00981110
Start Date
June 1 2008
End Date
December 1 2010
Last Update
September 11 2012
Active Locations (2)
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1
S. Gerardo Hospital
Monza, Monza, Italy, 20052
2
European Institute of Oncology
Milan, Italy