Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery (AM)

European Institute of Oncology

Status and phase

Completed

Phase 3

Conditions

Colorectal Cancer

Treatments

Device: Mepore Self-adhesive absorbent dressing

Device: AQUAGEL Ag Hydrofiber Wound Dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT00981110

IEO S402/208

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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